Frontotemporal DementiaFORWARDNCT03088956
Cognitive, Behavioral, and Functional Change in Behavioral Variant Frontotemporal Dementia (bvFTD)
An observational study of Frontotemporal Dementia and Behavioral Variant Frontotemporal Dementia, run by Biogen at 12 sites in United States.
Trial summary
The objectives of the study are to; (1) estimate the change in disease -related cognitive decline over 1 year on a battery of cognitive tests administered to participants with early-stage symptomatic Behavioral Variant Frontotemporal Dementia (bvFTD) phenotypic variant; (2) identify the cognitive test or brief battery… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Frontotemporal Dementia, Behavioral Variant Frontotemporal Dementia
- What is being tested?
- Assessments
- How many people
- 47 participants
- Where
- 12 sitesUnited States
- Study dates
- 19 Jan 2018to 23 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Academic centers, Hospitals, Clinics
Who may be able to join
- Must speak and understand oral and written English.
- Must be in good general health determined by Investigator.
Who cannot join
- Concomitant motor neuron disease with limb or bulbar weakness which, in the opinion of the Investigator, may affect performance over the course of the study. Participants with bvFTD with motor neuron disease are otherwise allowed to participate.
- Known presence of a structural brain lesion that could reasonably explain symptoms.
- Diagnosis of Alzheimer's disease and/or known presence of an Alzheimer's disease causing mutation in PSEN1, PSEN2 or APP; or neuropathological evidence for Alzheimer's disease as a cause of syndrome.
- History of other acute or chronic neurological or psychiatric conditions that are unrelated and may confound a diagnosis of bvFTD and that, in the opinion of the Investigator, may affect cognition, behavior, or ability to complete the study.
- History of severe alcohol or substance abuse.
- History of disorders that could confound a diagnosis of bvFTD.
Show all 11Show fewer
- Use of allowed chronic medications at doses that have not been stable for at least 4 weeks prior to Screening.
- Current use of psychoactive medication that will interfere with accurate assessment of cognition (as assessed by the Investigator)
- History of alcohol or substance abuse.
- Current use of psychoactive medication that will interfere with accurate assessment of cognition (as assessed by the Investigator).
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Research Site
Atlanta, Georgia, 30322
Research Site
Baltimore, Maryland, 21218
Research Site
Birmingham, Alabama, 35233
Research Site
Boca Raton, Florida, 33431
Research Site
Boca Raton, Florida, 33486
Research Site
Columbus, Ohio, 43220
Research Site
Elk Grove Village, Illinois, 60007
Research Site
Knoxville, Tennessee, 37909
Research Site
Los Angeles, California, 90095
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
Rochester, Minnesota, 55905
Research Site
Seattle, Washington, 98104
About this study
Official title: A Study to Model Rates of Change on Neuropsychological Test Measures in Subjects Diagnosed With Behavioral Variant Frontotemporal Dementia and Healthy Subjects
The objectives of the study are to; (1) estimate the change in disease -related cognitive decline over 1 year on a battery of cognitive tests administered to participants with early-stage symptomatic Behavioral Variant Frontotemporal Dementia (bvFTD) phenotypic variant; (2) identify the cognitive test or brief battery of cognitive tests which are the most sensitive to detect bvFTD progression; (3) determine the optimal schedule of administration of cognitive tests to detect bvFTD progression; (4) evaluate the relationship between cognitive tests and measures of behavior, function, caregiver's burden, quality of life (QOL); and (5) obtain blood samples for genetic and exploratory biomarkers correlations.
- Being tested
- Assessments
- Keywords
- Longitudinal, Caregiver, Cognitive assessments, Behavioral assessments, Functional assessments
- Medical subject headings
- Frontotemporal Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentsOther
Cognitive, Behavioral and Functional as described in the Outcome Measures
| Study group | Role | What they receive |
|---|---|---|
| bvFTD | Participants with behavioral variant frontotemporal dementia (bvFTD) (n=37) Receives: Other: Assessments | |
| Healthy | Healthy Participants (n=10) Receives: Other: Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized rate of change in International Shopping List Test (ISLT) - Immediate Recall
ISLT uses a word list learning paradigm to measure verbal learning. The score for this test is based on the total number of correct responses made in remembering the list on 3 consecutive trials at a single session. Higher scores indicate better performance.
Measured: Up to 12 Months
Annualized rate of change in Detection Test
A test that uses a simple reaction time paradigm to measure psychomotor function. The score for this test is based on the speed of performance, measured as the mean of the log10 transformed reaction times for correct responses. Lower scores indicate better performance.
Measured: Up to 12 Months
Annualized rate of change in Identification Test
A test that uses a choice reaction time paradigm to measure attention. The score for this test is based on the speed of performance, measured as the mean of the log10 transformed reaction times for correct responses. Lower scores indicate better performance.
Measured: Up to 12 Months
Annualized rate of change in One Back Test
A test that uses an n-back paradigm to measure working memory. The score for this test is based on the speed of performance, measured as the mean of the log10 transformed reaction times for correct responses. Lower scores indicate better performance.
Measured: Up to 12 Months
Annualized rate of change in Groton Maze Learning Test
Modified version (10 x 10, "snake maze" version): this is a test that uses a maze learning paradigm to measure executive function and spatial learning. The score for this test is based on the total number of errors made in attempting to learn the same hidden pathway on 5 consecutive trials at a single session. Lower scores indicate better performance.
Measured: Up to 12 Months
Annualized rate of change in ISLT - Delayed Recall
A test that uses a word list paradigm to measure verbal memory. The score for this test is based on the total number of correct responses made in remembering the list after a delay. Higher scores indicate better performance.
Measured: Up to 12 Months
Annualized rate of change in Social Emotional Cognition Test (SECT)
A test that uses an odd-man-out paradigm to measure social cognition. The score for this test is based on the accuracy of performance, measured as the arcsine transformation of the square root of the proportion of correct responses. Higher scores indicate better performance.
Measured: Up to 12 Months
Annualized rate of change in Letter Fluency
A test that assesses executive function by asking the participant to state as many words as possible starting with a specific letter. The score for this test is based on the number of words generated. Higher scores indicate better performance.
Measured: Up to 12 Months
Annualized rate of change in Category Fluency
A test that assesses executive function by asking the participant to state as many words as possible within a given category. The score for this test is based on the number of words generated. Higher scores indicate better performance.
Measured: Up to 12 Months
Annualized rate of change in Digit Symbol Coding (DSC)
A paper and pencil test that assesses attention, working memory, and executive function. The participant is presented with a paper on top of which is printed a key showing numerals paired with symbols and on the bottom are rows of numerals with a blank space beneath each one. The participant is instructed to draw the symbol that matches each numeral and to complete as many as possible in order in 2 minutes. The score for this test is the number of correct responses. Higher scores indicate better performance.
Measured: Up to 12 Months
Annualized rate of change in Letter Number Sequencing (LNS)
A test that assesses working memory by asking the participant to recall series of numbers and letters presented in random order, but to respond by reciting the numbers in ascending order followed by letters in alphabetical order. The score for this test is based on the number of correct answers. Higher scores indicate better performance.
Measured: Up to 12 Months
Annualized rate of change in Mini Mental State Examination (MMSE)
A test that assesses working memory by asking the participant to recall series of numbers and letters presented in random order, but to respond by reciting the numbers in ascending order followed by letters in alphabetical order. The score for this test is based on the number of correct answers. Higher scores indicate better performance.
Measured: Up to 12 Months
Change from Day 1 in International Shopping List Test (ISLT) - Immediate Recall
ISLT uses a word list learning paradigm to measure verbal learning. The score for this test is based on the total number of correct responses made in remembering the list on 3 consecutive trials at a single session. Higher scores indicate better performance.
Measured: Up to 12 Months
Change from Day 1 in Detection Test
A test that uses a simple reaction time paradigm to measure psychomotor function. The score for this test is based on the speed of performance, measured as the mean of the log10 transformed reaction times for correct responses. Lower scores indicate better performance.
Measured: Up to 12 Months
Change from Day 1 in Identification Test
A test that uses a choice reaction time paradigm to measure attention. The score for this test is based on the speed of performance, measured as the mean of the log10 transformed reaction times for correct responses. Lower scores indicate better performance.
Measured: Up to 12 Months
Change from Day 1 in One Back Test
A test that uses an n-back paradigm to measure working memory. The score for this test is based on the speed of performance, measured as the mean of the log10 transformed reaction times for correct responses. Lower scores indicate better performance.
Measured: Up to 12 Months
Change from Day 1 in Groton Maze Learning Test
Modified version (10 x 10, "snake maze" version): this is a test that uses a maze learning paradigm to measure executive function and spatial learning. The score for this test is based on the total number of errors made in attempting to learn the same hidden pathway on 5 consecutive trials at a single session. Lower scores indicate better performance.
Measured: Up to 12 Months
Change from Day 1 in ISLT- Delayed Recall
A test that uses a word list paradigm to measure verbal memory. The score for this test is based on the total number of correct responses made in remembering the list after a delay. Higher scores indicate better performance.
Measured: Up to 12 Months
Change from Day 1 in SECT
A test that uses an odd-man-out paradigm to measure social cognition. The score for this test is based on the accuracy of performance, measured as the arcsine transformation of the square root of the proportion of correct responses. Higher scores indicate better performance.
Measured: Up to 12 Months
Change from Day 1 in Letter Fluency
A test that assesses executive function by asking the participant to state as many words as possible starting with a specific letter. The score for this test is based on the number of words generated. Higher scores indicate better performance.
Measured: Up to 12 Months
Change from Day 1 in Category Fluency
A test that assesses executive function by asking the participant to state as many words as possible within a given category. The score for this test is based on the number of words generated. Higher scores indicate better performance.
Measured: Up to 12 Months
Change from Day 1 in DSC
A paper and pencil test that assesses attention, working memory, and executive function. The participant is presented with a paper on top of which is printed a key showing numerals paired with symbols and on the bottom are rows of numerals with a blank space beneath each one. The participant is instructed to draw the symbol that matches each numeral and to complete as many as possible in order in 2 minutes. The score for this test is the number of correct responses. Higher scores indicate better performance.
Measured: Up to 12 Months
Change from Day 1 in LNS
A test that assesses working memory by asking the participant to recall series of numbers and letters presented in random order, but to respond by reciting the numbers in ascending order followed by letters in alphabetical order. The score for this test is based on the number of correct answers. Higher scores indicate better performance.
Measured: Up to 12 Months
Change from Day 1 in MMSE
A test that assesses working memory by asking the participant to recall series of numbers and letters presented in random order, but to respond by reciting the numbers in ascending order followed by letters in alphabetical order. The score for this test is based on the number of correct answers. Higher scores indicate better performance.
Measured: Up to 12 months
Actual values from Day 1 in Neurophsychic Inventory (NPI)
A 12-item participant and caregiver interview based questionnaire assessing behavioral domains which are common in dementia: hallucinations, delusions, agitation/aggression, dysphoria/depression, anxiety, irritability, disinhibition, euphoria, apathy, aberrant motor behavior, sleep and night-time behavior disorders, and appetite and eating disorders. Each domain is scored for frequency on a 4-item scale (1 = rarely to 4 = very often), for severity on a 3-item scale (1 = mild to 3 = severe), and for associated caregiver distress on a 6-item scale (0 = not at all to 5 = very severe or extremely).
Measured: Up to 12 Months
Change from Day 1 in NPI
A 12-item participant and caregiver interview based questionnaire assessing behavioral domains which are common in dementia: hallucinations, delusions, agitation/aggression, dysphoria/depression, anxiety, irritability, disinhibition, euphoria, apathy, aberrant motor behavior, sleep and night-time behavior disorders, and appetite and eating disorders. Each domain is scored for frequency on a 4-item scale (1 = rarely to 4 = very often), for severity on a 3-item scale (1 = mild to 3 = severe), and for associated caregiver distress on a 6-item scale (0 = not at all to 5 = very severe or extremely).
Measured: Up to 12 Months
Actual values from Day 1 in Neurophsychic Inventory Questionnaire (NPI-Q)
A shorter version of the NPI, intended for use in routine clinical practice. The NPI-Q contains 12 questions scored on symptom presence (yes/no) and severity (mild, moderate, and severe). Frequency on a 4-item scale (rarely to very often) and associated caregiver distress on a 6-item scale (0 = not at all to 5 = very severe or extreme) will also be collected.
Measured: Up to 12 Months
Change from Day 1 in NPI-Q
A shorter version of the NPI, intended for use in routine clinical practice. The NPI-Q contains 12 questions scored on symptom presence (yes/no) and severity (mild, moderate, and severe). Frequency on a 4-item scale (rarely to very often) and associated caregiver distress on a 6-item scale (0 = not at all to 5 = very severe or extreme) will also be collected.
Measured: Up to 12 Months
Actual values from Day 1 in Revised Self-Monitoring Scale
A 13-item version of the Self-Monitoring Scale [Snyder 1974] which measures sensitivity to the expressive behavior of others and ability to modify self-presentation.
Measured: Up to 12 Months
Change from Day 1 in Revised Self-Monitoring Scale
A 13-item version of the Self-Monitoring Scale [Snyder 1974] which measures sensitivity to the expressive behavior of others and ability to modify self-presentation.
Measured: Up to 12 Months
Actual values from Day 1 in Apathy Inventory
Assesses 3 dimensions of apathy: emotional blunting, lack of initiative, and lack of interest, with 1 version each for participants, caregivers, and clinicians. Higher scores reflect greater apathy. For the participant version, yes/no responses are captured for each dimension, then a visual analogue scale or numeric evaluation from 1-12 is captured for severity of functioning (1=mild to 12=extremely severe), for a total score of 36. For the caregiver version, each dimension is scored on a 12-point Likert scale based on frequency (1=occasionally to 4=very frequently: and severity (1=mild to 3=marked), for a total score of 36. The clinician version captures each domain on a scale from 0 to 4 (0=no problem to 4=major problem), for a total score of 12.
Measured: Up to 12 Months
Change from Day 1 in Apathy Inventory
Assesses 3 dimensions of apathy: emotional blunting, lack of initiative , and lack of interest , with 1 version each for participants, caregivers, and clinicians. Higher scores reflect greater apathy. For the participant version, yes/no responses are captured for each dimension, then a visual analogue scale or numeric evaluation from 1-12 is captured for severity of functioning (1=mild to 12=extremely severe), for a total score of 36. For the caregiver version, each dimension is scored on a 12-point Likert scale based on frequency (1=occasionally to 4=very frequently: and severity (1=mild to 3=marked), for a total score of 36. The clinician version captures each domain on a scale from 0 to 4 (0=no problem to 4=major problem), for a total score of 12.
Measured: Up to 12 Months
Actual values from Day 1 in Family Accommodation Scale for Obsessive Compulsive Disorder - Self Rated (FAS-SR)
This is a self-rated version of the Family Accommodation Scale for Obsessive Compulsive Disorder to be completed by the caregiver, which assesses the number of days with accommodating behaviors in the past week using a 5-point Likert scale (0 = none to 4 = every day).
Measured: Up to 12 Months
Change from Day 1 in FAS-SR
This is a self-rated version of the Family Accommodation Scale for Obsessive Compulsive Disorder to be completed by the caregiver, which assesses the number of days with accommodating behaviors in the past week using a 5-point Likert scale (0 = none to 4 = every day).
Measured: Up to 12 Months
Actual values from Day 1 in Behavior Rating Scale
A questionnaire completed by the clinic rater assessing participant's behaviors on a 4-item severity scale (none to severe). Behaviors include agitation, stimulus boundedness, perseverative behavior, decreased initiation, motor stereotypies, distractibility, lack of social/emotional engagement, impulsivity, socially inappropriateness, and impaired or fluctuating levels of alertness.
Measured: Up to 12 Months
Change from Day 1 in Behavior Rating Scale
A questionnaire completed by the clinic rater assessing participant's behaviors on a 4-item severity scale (none to severe). Behaviors include agitation, stimulus boundedness, perseverative behavior, decreased initiation, motor stereotypies, distractibility, lack of social/emotional engagement, impulsivity, socially inappropriateness, and impaired or fluctuating levels of alertness.
Measured: Up to 12 Months
Actual values from Day 1 in Functional Activities Questionnaire (FAQ)
A 10-item questionnaire designed to assess independence in participants with Alzheimer's Disease by measuring instrumental activities of daily living. Each question is rated on a 4-point Likert scale (0 = normal to 3 = dependent).
Measured: Up to 12 Months
Change from Day 1 in FAQ
A 10-item questionnaire designed to assess independence in participants with Alzheimer's Disease by measuring instrumental activities of daily living. Each question is rated on a 4-point Likert scale (0 = normal to 3 = dependent).
Measured: Up to 12 Months
Actual values from Day 1 in Clinical Global Impression of Change (CGIC)
This is 1 of the items of the Clinical Global Impression, and measures clinical change as improvement or worsening. It is scored on a 7-point Likert scale (marked improvement to no change and to marked worsening).
Measured: Up to 12 Months
Change from Day 1 in CGIC
This is 1 of the items of the Clinical Global Impression, and measures clinical change as improvement or worsening. It is scored on a 7-point Likert scale (marked improvement to no change and to marked worsening).
Measured: Up to 12 Months
Actual values from Day 1 in Clinical Dementia Rating-Frontotemporal Lobar Degeneration (CDR-FTLD)
An FTLD-modified CDR scale (initially developed for Alzheimer's Disease) which includes 2 additional domains: behavior/comportment/personality and language, to the CDR 6 domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain is scored on a 5-point impairment Likert scale (normal to severe dementia).
Measured: Up to 12 Months
Change from Day 1 in CDR-FTLD
An FTLD-modified CDR scale (initially developed for Alzheimer's Disease) which includes 2 additional domains: behavior/comportment/personality and language, to the CDR 6 domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain is scored on a 5-point impairment Likert scale (normal to severe dementia).
Measured: Up to 12 Months
Actual values from Day 1 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III
A motor examination domain of the UPDRS, designed to assess progression of Parkinson's disease. It consists of 14 questions scored on a 5-point severity Likert scale (0 to 4).
Measured: Up to 12 Months
Change from Day 1 in UPDRS Part III
A motor examination domain of the UPDRS, designed to assess progression of Parkinson's disease. It consists of 14 questions scored on a 5-point severity Likert scale (0 to 4).
Measured: Up to 12 Months
Actual values from Day 1 of caregiver's Quality of Life (QOL) in Zarit Caregiver Burden Interview
A caregiver self-reported measure to assess level of burden when taking care of someone, consisting of a 22-item questionnaire. Each question is scored on a 5-point Likert scale (0 = never to 4 = nearly always).
Measured: Up to 12 Months
Change from Day 1 of caregiver's QOL in Zarit Caregiver Burden Interview
A caregiver self-reported measure to assess level of burden when taking care of someone, consisting of a 22-item questionnaire. Each question is scored on a 5-point Likert scale (0 = never to 4 = nearly always).
Measured: Up to 12 Months
Actual values from Day 1 of QOL in Geriatric Depression Scale- Short Form (GDS-SF)
A 15-item questionnaire developed to assess depression symptoms in elderly participants (55 years or older). Each question is scored as yes/no. This measure has been used in similar dementia populations, such as Alzheimer's and Parkinson's, in addition to 1 FTD study [Matsuzono 2015]. While the population in this study may be a bit younger, this measure will be tested for use in the bvFTD population included.
Measured: Up to 12 Months
Change from Day 1 of QOL in GDS-SF
A 15-item questionnaire developed to assess depression symptoms in elderly participants (55 years or older). Each question is scored as yes/no. This measure has been used in similar dementia populations, such as Alzheimer's and Parkinson's, in addition to 1 FTD study [Matsuzono 2015]. While the population in this study may be a bit younger, this measure will be tested for use in the bvFTD population included.
Measured: Up to 12 Months
Actual values from Day 1 of caregiver's QOL in Caregiver Assessment Measure
A questionnaire developed by Biogen which consists of 4 questions. The first 2 questions are scored on a 5-point Likert scale (0 = not at all to 4 = a great deal) and refer to the impact of the participant's disease on the caregiver. The third question refers to the change in the participant's need of care; in case this has increased, an additional question is to be scored on a 5-point Likert scale (0 = a little more care to 4 = a great deal more care). The last question refers to the amount of care (hours per day).
Measured: Up to 12 Months
Change from Day 1 of caregiver's QOL in Caregiver Assessment Measure
A questionnaire developed by Biogen which consists of 4 questions. The first 2 questions are scored on a 5-point Likert scale (0 = not at all to 4 = a great deal) and refer to the impact of the participant's disease on the caregiver. The third question refers to the change in the participant's need of care; in case this has increased, an additional question is to be scored on a 5-point Likert scale (0 = a little more care to 4 = a great deal more care). The last question refers to the amount of care (hours per day).
Measured: Up to 12 Months
Actual values from Day 1 of QOL in Quality of Life in Neurological Disorders (NeuroQOL)
A self-reported health-related quality of life (HRQL) assessment for adults with a neurological disorder, which measures 3 areas: physical health, mental health, and social health. All NeuroQOL items have 5 response options (1 = not at all to 5 = very much). Higher scores represent more impairment or worse health. Participants with bvFTD will complete the following sections of the NeuroQOL: Cognitive Function SF, Emotional and Behavioral Dyscontrol SF and Ability to Participate in Social Roles and Activities SF. Caregivers will complete the following sections of the NeuroQOL: Satisfaction with Social Roles SF and Activities and Ability to Participate in Social Roles and Activities SF.
Measured: Up to 12 Months
Change from Day 1 of QOL in Quality of Life in NeuroQOL
A self-reported health-related quality of life (HRQL) assessment for adults with a neurological disorder, which measures 3 areas: physical health, mental health, and social health. All NeuroQOL items have 5 response options (1 = not at all to 5 = very much). Higher scores represent more impairment or worse health. Participants with bvFTD will complete the following sections of the NeuroQOL: Cognitive Function SF, Emotional and Behavioral Dyscontrol SF and Ability to Participate in Social Roles and Activities SF. Caregivers will complete the following sections of the NeuroQOL: Satisfaction with Social Roles SF and Activities and Ability to Participate in Social Roles and Activities SF.
Measured: Up to 12 Months
Actual values from Day 1 of QOL in EuroOol 5 Dimensions Questionnaire (EQ-5D)
A self-reported generic HRQL assessment with 2 parts, the first containing 5 tick boxes (no problems, some problems, moderate problems, severe problems, cannot do) to select the most appropriate statement on each of its 5 domains (mobility, self care, usual activities, anxiety/ depression, and pain), and the second with a visual analogue scale ranging from "the best health you can imagine" to "the worst health you can imagine". This version with 5 response levels is called the EQ-5D-5L.
Measured: Up to 12 Months
Change from Day 1 of QOL in EQ-5D
A self-reported generic HRQL assessment with 2 parts, the first containing 5 tick boxes (no problems, some problems, moderate problems, severe problems, cannot do) to select the most appropriate statement on each of its 5 domains (mobility, self care, usual activities, anxiety/ depression, and pain), and the second with a visual analogue scale ranging from "the best health you can imagine" to "the worst health you can imagine". This version with 5 response levels is called the EQ-5D-5L.
Measured: Up to 12 Months
Actual values from Day 1 of QOL in Affect and Activity Indicators of QOL (AAIQOL)
A measure of caregiver-reported (proxy) QOL in participants with dementia which assesses 2 domains: activity and affect. Activity is a 15-item questionnaire rated on opportunity (no/yes), frequency (none/few/often), and enjoyment (yes/no), with 5 items for outdoors activities and 10 items for home activities. Affect is a 6-item questionnaire, with 3 items for positive effects and 3 items for negative effects, referring to the previous 2 weeks, and scored on a 5-point Likert scale (1 = never to 5 = several [3+] times per day).
Measured: Up to 12 Months
Change from Day 1 of QOL in AAIQOL
A measure of caregiver-reported (proxy) QOL in participants with dementia which assesses 2 domains: activity and affect. Activity is a 15-item questionnaire rated on opportunity (no/yes), frequency (none/few/often), and enjoyment (yes/no), with 5 items for outdoors activities and 10 items for home activities. Affect is a 6-item questionnaire, with 3 items for positive effects and 3 items for negative effects, referring to the previous 2 weeks, and scored on a 5-point Likert scale (1 = never to 5 = several [3+] times per day).
Measured: Up to 12 Months
Actual values from Day 1 for exploratory biomarkers
Venipuncture for collection of whole blood samples for exploratory blood biomarkers analyses.
Measured: Baseline, Month 12
Change from Day 1 for exploratory blood biomarkers
Venipuncture for collection of whole blood samples for exploratory blood biomarkers analyses.
Measured: Baseline, Month 12
bvFTD genetic mutations identification in whole blood samples
Venipuncture for collection of whole blood samples for identification of bvFTD genetic mutations.
Measured: Baseline, Month 12
Potential identification of genetic biomarkers associated with bvFTD from DNA/RNA in whole blood samples
Venipuncture for collection of whole blood samples for potential identification of genetic biomarkers associated with bvFTD.
Measured: Baseline, Month 12
Actual values at Day 1 in Clinical Global Impression of Severity (CGIS)
This is one of the items of the Clinical Global Impression, and measures clinical severity at baseline. It is rated on a 7-point Likert scale, with illness being rated in the range of 1 (normal) to 7 (severely ill). It requires the clinician to rate the severity of the participant's illness at the time of the assessment, relative to the clinician's past experience with participants who have the same diagnosis.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start19 Jan 2018
- Primary completion23 Sep 2019
- Study completion23 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frontotemporal DementiaStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088956
- Sponsor's protocol ID
- 992FD001
- Acronym
- FORWARD
- Status last verified
- Jun 2020
- First submitted
- 17 Mar 2017
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Model Rates of Change on Neuropsychological Test Measures in Subjects Diagnosed With Behavioral Variant Frontotemporal Dementia and Healthy Subjects
- ClinicalTrials.gov ID
- NCT03088956
- Acronym / sponsor ID
- FORWARD / 992FD001
- Keywords
- Longitudinal, Caregiver, Cognitive assessments, Behavioral assessments, Functional assessments
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 23 Sep 2019 (actual)
- Study completion
- 23 Sep 2019 (actual)
- First posted
- 24 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of the study are to; (1) estimate the change in disease -related cognitive decline over 1 year on a battery of cognitive tests administered to participants with early-stage symptomatic Behavioral Variant Frontotemporal Dementia (bvFTD) phenotypic variant; (2) identify the cognitive test or brief battery of cognitive tests which are the most sensitive to detect bvFTD progression; (3) determine the optimal schedule of administration of cognitive tests to detect bvFTD progression; (4) evaluate the relationship between cognitive tests and measures of behavior, function, caregiver's burden, quality of life (QOL); and (5) obtain blood samples for genetic and exploratory biomarkers correlations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bvFTD | – | Other: AssessmentsParticipants with behavioral variant frontotemporal dementia (bvFTD) (n=37) |
| Healthy | – | Other: AssessmentsHealthy Participants (n=10) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Academic centers, Hospitals, Clinics
Key inclusion criteria (2 listed)
- Must speak and understand oral and written English.
- Must be in good general health determined by Investigator.
Key exclusion criteria (11 listed)
- Concomitant motor neuron disease with limb or bulbar weakness which, in the opinion of the Investigator, may affect performance over the course of the study. Participants with bvFTD with motor neuron disease are otherwise allowed to participate.
- Known presence of a structural brain lesion that could reasonably explain symptoms.
- Diagnosis of Alzheimer's disease and/or known presence of an Alzheimer's disease causing mutation in PSEN1, PSEN2 or APP; or neuropathological evidence for Alzheimer's disease as a cause of syndrome.
- History of other acute or chronic neurological or psychiatric conditions that are unrelated and may confound a diagnosis of bvFTD and that, in the opinion of the Investigator, may affect cognition, behavior, or ability to complete the study.
- History of severe alcohol or substance abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AssessmentsCognitive, Behavioral and Functional as described in the Outcome Measures | Other | Healthy, bvFTD |
Primary outcome
Annualized rate of change in International Shopping List Test (ISLT) - Immediate Recall
Time frame: Up to 12 Months
ISLT uses a word list learning paradigm to measure verbal learning. The score for this test is based on the total number of correct responses made in remembering the list on 3 consecutive trials at a single session. Higher scores indicate better performance.
Annualized rate of change in Detection Test
Time frame: Up to 12 Months
A test that uses a simple reaction time paradigm to measure psychomotor function. The score for this test is based on the speed of performance, measured as the mean of the log10 transformed reaction times for correct responses. Lower scores indicate better performance.
Annualized rate of change in Identification Test
Time frame: Up to 12 Months
A test that uses a choice reaction time paradigm to measure attention. The score for this test is based on the speed of performance, measured as the mean of the log10 transformed reaction times for correct responses. Lower scores indicate better performance.
Annualized rate of change in One Back Test
Time frame: Up to 12 Months
A test that uses an n-back paradigm to measure working memory. The score for this test is based on the speed of performance, measured as the mean of the log10 transformed reaction times for correct responses. Lower scores indicate better performance.
Annualized rate of change in Groton Maze Learning Test
Time frame: Up to 12 Months
Modified version (10 x 10, "snake maze" version): this is a test that uses a maze learning paradigm to measure executive function and spatial learning. The score for this test is based on the total number of errors made in attempting to learn the same hidden pathway on 5 consecutive trials at a single session. Lower scores indicate better performance.
Annualized rate of change in ISLT - Delayed Recall
Time frame: Up to 12 Months
A test that uses a word list paradigm to measure verbal memory. The score for this test is based on the total number of correct responses made in remembering the list after a delay. Higher scores indicate better performance.
Annualized rate of change in Social Emotional Cognition Test (SECT)
Time frame: Up to 12 Months
A test that uses an odd-man-out paradigm to measure social cognition. The score for this test is based on the accuracy of performance, measured as the arcsine transformation of the square root of the proportion of correct responses. Higher scores indicate better performance.
Annualized rate of change in Letter Fluency
Time frame: Up to 12 Months
A test that assesses executive function by asking the participant to state as many words as possible starting with a specific letter. The score for this test is based on the number of words generated. Higher scores indicate better performance.
Annualized rate of change in Category Fluency
Time frame: Up to 12 Months
A test that assesses executive function by asking the participant to state as many words as possible within a given category. The score for this test is based on the number of words generated. Higher scores indicate better performance.
Annualized rate of change in Digit Symbol Coding (DSC)
Time frame: Up to 12 Months
A paper and pencil test that assesses attention, working memory, and executive function. The participant is presented with a paper on top of which is printed a key showing numerals paired with symbols and on the bottom are rows of numerals with a blank space beneath each one. The participant is instructed to draw the symbol that matches each numeral and to complete as many as possible in order in 2 minutes. The score for this test is the number of correct responses. Higher scores indicate better performance.
Annualized rate of change in Letter Number Sequencing (LNS)
Time frame: Up to 12 Months
A test that assesses working memory by asking the participant to recall series of numbers and letters presented in random order, but to respond by reciting the numbers in ascending order followed by letters in alphabetical order. The score for this test is based on the number of correct answers. Higher scores indicate better performance.
Annualized rate of change in Mini Mental State Examination (MMSE)
Time frame: Up to 12 Months
A test that assesses working memory by asking the participant to recall series of numbers and letters presented in random order, but to respond by reciting the numbers in ascending order followed by letters in alphabetical order. The score for this test is based on the number of correct answers. Higher scores indicate better performance.
Change from Day 1 in International Shopping List Test (ISLT) - Immediate Recall
Time frame: Up to 12 Months
ISLT uses a word list learning paradigm to measure verbal learning. The score for this test is based on the total number of correct responses made in remembering the list on 3 consecutive trials at a single session. Higher scores indicate better performance.
Change from Day 1 in Detection Test
Time frame: Up to 12 Months
A test that uses a simple reaction time paradigm to measure psychomotor function. The score for this test is based on the speed of performance, measured as the mean of the log10 transformed reaction times for correct responses. Lower scores indicate better performance.
Change from Day 1 in Identification Test
Time frame: Up to 12 Months
A test that uses a choice reaction time paradigm to measure attention. The score for this test is based on the speed of performance, measured as the mean of the log10 transformed reaction times for correct responses. Lower scores indicate better performance.
Change from Day 1 in One Back Test
Time frame: Up to 12 Months
A test that uses an n-back paradigm to measure working memory. The score for this test is based on the speed of performance, measured as the mean of the log10 transformed reaction times for correct responses. Lower scores indicate better performance.
Change from Day 1 in Groton Maze Learning Test
Time frame: Up to 12 Months
Modified version (10 x 10, "snake maze" version): this is a test that uses a maze learning paradigm to measure executive function and spatial learning. The score for this test is based on the total number of errors made in attempting to learn the same hidden pathway on 5 consecutive trials at a single session. Lower scores indicate better performance.
Change from Day 1 in ISLT- Delayed Recall
Time frame: Up to 12 Months
A test that uses a word list paradigm to measure verbal memory. The score for this test is based on the total number of correct responses made in remembering the list after a delay. Higher scores indicate better performance.
Change from Day 1 in SECT
Time frame: Up to 12 Months
A test that uses an odd-man-out paradigm to measure social cognition. The score for this test is based on the accuracy of performance, measured as the arcsine transformation of the square root of the proportion of correct responses. Higher scores indicate better performance.
Change from Day 1 in Letter Fluency
Time frame: Up to 12 Months
A test that assesses executive function by asking the participant to state as many words as possible starting with a specific letter. The score for this test is based on the number of words generated. Higher scores indicate better performance.
Change from Day 1 in Category Fluency
Time frame: Up to 12 Months
A test that assesses executive function by asking the participant to state as many words as possible within a given category. The score for this test is based on the number of words generated. Higher scores indicate better performance.
Change from Day 1 in DSC
Time frame: Up to 12 Months
A paper and pencil test that assesses attention, working memory, and executive function. The participant is presented with a paper on top of which is printed a key showing numerals paired with symbols and on the bottom are rows of numerals with a blank space beneath each one. The participant is instructed to draw the symbol that matches each numeral and to complete as many as possible in order in 2 minutes. The score for this test is the number of correct responses. Higher scores indicate better performance.
Change from Day 1 in LNS
Time frame: Up to 12 Months
A test that assesses working memory by asking the participant to recall series of numbers and letters presented in random order, but to respond by reciting the numbers in ascending order followed by letters in alphabetical order. The score for this test is based on the number of correct answers. Higher scores indicate better performance.
Change from Day 1 in MMSE
Time frame: Up to 12 months
A test that assesses working memory by asking the participant to recall series of numbers and letters presented in random order, but to respond by reciting the numbers in ascending order followed by letters in alphabetical order. The score for this test is based on the number of correct answers. Higher scores indicate better performance.
Actual values from Day 1 in Neurophsychic Inventory (NPI)
Time frame: Up to 12 Months
A 12-item participant and caregiver interview based questionnaire assessing behavioral domains which are common in dementia: hallucinations, delusions, agitation/aggression, dysphoria/depression, anxiety, irritability, disinhibition, euphoria, apathy, aberrant motor behavior, sleep and night-time behavior disorders, and appetite and eating disorders. Each domain is scored for frequency on a 4-item scale (1 = rarely to 4 = very often), for severity on a 3-item scale (1 = mild to 3 = severe), and for associated caregiver distress on a 6-item scale (0 = not at all to 5 = very severe or extremely).
Change from Day 1 in NPI
Time frame: Up to 12 Months
A 12-item participant and caregiver interview based questionnaire assessing behavioral domains which are common in dementia: hallucinations, delusions, agitation/aggression, dysphoria/depression, anxiety, irritability, disinhibition, euphoria, apathy, aberrant motor behavior, sleep and night-time behavior disorders, and appetite and eating disorders. Each domain is scored for frequency on a 4-item scale (1 = rarely to 4 = very often), for severity on a 3-item scale (1 = mild to 3 = severe), and for associated caregiver distress on a 6-item scale (0 = not at all to 5 = very severe or extremely).
Actual values from Day 1 in Neurophsychic Inventory Questionnaire (NPI-Q)
Time frame: Up to 12 Months
A shorter version of the NPI, intended for use in routine clinical practice. The NPI-Q contains 12 questions scored on symptom presence (yes/no) and severity (mild, moderate, and severe). Frequency on a 4-item scale (rarely to very often) and associated caregiver distress on a 6-item scale (0 = not at all to 5 = very severe or extreme) will also be collected.
Change from Day 1 in NPI-Q
Time frame: Up to 12 Months
A shorter version of the NPI, intended for use in routine clinical practice. The NPI-Q contains 12 questions scored on symptom presence (yes/no) and severity (mild, moderate, and severe). Frequency on a 4-item scale (rarely to very often) and associated caregiver distress on a 6-item scale (0 = not at all to 5 = very severe or extreme) will also be collected.
Actual values from Day 1 in Revised Self-Monitoring Scale
Time frame: Up to 12 Months
A 13-item version of the Self-Monitoring Scale [Snyder 1974] which measures sensitivity to the expressive behavior of others and ability to modify self-presentation.
Change from Day 1 in Revised Self-Monitoring Scale
Time frame: Up to 12 Months
A 13-item version of the Self-Monitoring Scale [Snyder 1974] which measures sensitivity to the expressive behavior of others and ability to modify self-presentation.
Actual values from Day 1 in Apathy Inventory
Time frame: Up to 12 Months
Assesses 3 dimensions of apathy: emotional blunting, lack of initiative, and lack of interest, with 1 version each for participants, caregivers, and clinicians. Higher scores reflect greater apathy. For the participant version, yes/no responses are captured for each dimension, then a visual analogue scale or numeric evaluation from 1-12 is captured for severity of functioning (1=mild to 12=extremely severe), for a total score of 36. For the caregiver version, each dimension is scored on a 12-point Likert scale based on frequency (1=occasionally to 4=very frequently: and severity (1=mild to 3=marked), for a total score of 36. The clinician version captures each domain on a scale from 0 to 4 (0=no problem to 4=major problem), for a total score of 12.
Change from Day 1 in Apathy Inventory
Time frame: Up to 12 Months
Assesses 3 dimensions of apathy: emotional blunting, lack of initiative , and lack of interest , with 1 version each for participants, caregivers, and clinicians. Higher scores reflect greater apathy. For the participant version, yes/no responses are captured for each dimension, then a visual analogue scale or numeric evaluation from 1-12 is captured for severity of functioning (1=mild to 12=extremely severe), for a total score of 36. For the caregiver version, each dimension is scored on a 12-point Likert scale based on frequency (1=occasionally to 4=very frequently: and severity (1=mild to 3=marked), for a total score of 36. The clinician version captures each domain on a scale from 0 to 4 (0=no problem to 4=major problem), for a total score of 12.
Actual values from Day 1 in Family Accommodation Scale for Obsessive Compulsive Disorder - Self Rated (FAS-SR)
Time frame: Up to 12 Months
This is a self-rated version of the Family Accommodation Scale for Obsessive Compulsive Disorder to be completed by the caregiver, which assesses the number of days with accommodating behaviors in the past week using a 5-point Likert scale (0 = none to 4 = every day).
Change from Day 1 in FAS-SR
Time frame: Up to 12 Months
This is a self-rated version of the Family Accommodation Scale for Obsessive Compulsive Disorder to be completed by the caregiver, which assesses the number of days with accommodating behaviors in the past week using a 5-point Likert scale (0 = none to 4 = every day).
Actual values from Day 1 in Behavior Rating Scale
Time frame: Up to 12 Months
A questionnaire completed by the clinic rater assessing participant's behaviors on a 4-item severity scale (none to severe). Behaviors include agitation, stimulus boundedness, perseverative behavior, decreased initiation, motor stereotypies, distractibility, lack of social/emotional engagement, impulsivity, socially inappropriateness, and impaired or fluctuating levels of alertness.
Change from Day 1 in Behavior Rating Scale
Time frame: Up to 12 Months
A questionnaire completed by the clinic rater assessing participant's behaviors on a 4-item severity scale (none to severe). Behaviors include agitation, stimulus boundedness, perseverative behavior, decreased initiation, motor stereotypies, distractibility, lack of social/emotional engagement, impulsivity, socially inappropriateness, and impaired or fluctuating levels of alertness.
Actual values from Day 1 in Functional Activities Questionnaire (FAQ)
Time frame: Up to 12 Months
A 10-item questionnaire designed to assess independence in participants with Alzheimer's Disease by measuring instrumental activities of daily living. Each question is rated on a 4-point Likert scale (0 = normal to 3 = dependent).
Change from Day 1 in FAQ
Time frame: Up to 12 Months
A 10-item questionnaire designed to assess independence in participants with Alzheimer's Disease by measuring instrumental activities of daily living. Each question is rated on a 4-point Likert scale (0 = normal to 3 = dependent).
Actual values from Day 1 in Clinical Global Impression of Change (CGIC)
Time frame: Up to 12 Months
This is 1 of the items of the Clinical Global Impression, and measures clinical change as improvement or worsening. It is scored on a 7-point Likert scale (marked improvement to no change and to marked worsening).
Change from Day 1 in CGIC
Time frame: Up to 12 Months
This is 1 of the items of the Clinical Global Impression, and measures clinical change as improvement or worsening. It is scored on a 7-point Likert scale (marked improvement to no change and to marked worsening).
Actual values from Day 1 in Clinical Dementia Rating-Frontotemporal Lobar Degeneration (CDR-FTLD)
Time frame: Up to 12 Months
An FTLD-modified CDR scale (initially developed for Alzheimer's Disease) which includes 2 additional domains: behavior/comportment/personality and language, to the CDR 6 domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain is scored on a 5-point impairment Likert scale (normal to severe dementia).
Change from Day 1 in CDR-FTLD
Time frame: Up to 12 Months
An FTLD-modified CDR scale (initially developed for Alzheimer's Disease) which includes 2 additional domains: behavior/comportment/personality and language, to the CDR 6 domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain is scored on a 5-point impairment Likert scale (normal to severe dementia).
Actual values from Day 1 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III
Time frame: Up to 12 Months
A motor examination domain of the UPDRS, designed to assess progression of Parkinson's disease. It consists of 14 questions scored on a 5-point severity Likert scale (0 to 4).
Change from Day 1 in UPDRS Part III
Time frame: Up to 12 Months
A motor examination domain of the UPDRS, designed to assess progression of Parkinson's disease. It consists of 14 questions scored on a 5-point severity Likert scale (0 to 4).
Actual values from Day 1 of caregiver's Quality of Life (QOL) in Zarit Caregiver Burden Interview
Time frame: Up to 12 Months
A caregiver self-reported measure to assess level of burden when taking care of someone, consisting of a 22-item questionnaire. Each question is scored on a 5-point Likert scale (0 = never to 4 = nearly always).
Change from Day 1 of caregiver's QOL in Zarit Caregiver Burden Interview
Time frame: Up to 12 Months
A caregiver self-reported measure to assess level of burden when taking care of someone, consisting of a 22-item questionnaire. Each question is scored on a 5-point Likert scale (0 = never to 4 = nearly always).
Actual values from Day 1 of QOL in Geriatric Depression Scale- Short Form (GDS-SF)
Time frame: Up to 12 Months
A 15-item questionnaire developed to assess depression symptoms in elderly participants (55 years or older). Each question is scored as yes/no. This measure has been used in similar dementia populations, such as Alzheimer's and Parkinson's, in addition to 1 FTD study [Matsuzono 2015]. While the population in this study may be a bit younger, this measure will be tested for use in the bvFTD population included.
Change from Day 1 of QOL in GDS-SF
Time frame: Up to 12 Months
A 15-item questionnaire developed to assess depression symptoms in elderly participants (55 years or older). Each question is scored as yes/no. This measure has been used in similar dementia populations, such as Alzheimer's and Parkinson's, in addition to 1 FTD study [Matsuzono 2015]. While the population in this study may be a bit younger, this measure will be tested for use in the bvFTD population included.
Actual values from Day 1 of caregiver's QOL in Caregiver Assessment Measure
Time frame: Up to 12 Months
A questionnaire developed by Biogen which consists of 4 questions. The first 2 questions are scored on a 5-point Likert scale (0 = not at all to 4 = a great deal) and refer to the impact of the participant's disease on the caregiver. The third question refers to the change in the participant's need of care; in case this has increased, an additional question is to be scored on a 5-point Likert scale (0 = a little more care to 4 = a great deal more care). The last question refers to the amount of care (hours per day).
Change from Day 1 of caregiver's QOL in Caregiver Assessment Measure
Time frame: Up to 12 Months
A questionnaire developed by Biogen which consists of 4 questions. The first 2 questions are scored on a 5-point Likert scale (0 = not at all to 4 = a great deal) and refer to the impact of the participant's disease on the caregiver. The third question refers to the change in the participant's need of care; in case this has increased, an additional question is to be scored on a 5-point Likert scale (0 = a little more care to 4 = a great deal more care). The last question refers to the amount of care (hours per day).
Actual values from Day 1 of QOL in Quality of Life in Neurological Disorders (NeuroQOL)
Time frame: Up to 12 Months
A self-reported health-related quality of life (HRQL) assessment for adults with a neurological disorder, which measures 3 areas: physical health, mental health, and social health. All NeuroQOL items have 5 response options (1 = not at all to 5 = very much). Higher scores represent more impairment or worse health. Participants with bvFTD will complete the following sections of the NeuroQOL: Cognitive Function SF, Emotional and Behavioral Dyscontrol SF and Ability to Participate in Social Roles and Activities SF. Caregivers will complete the following sections of the NeuroQOL: Satisfaction with Social Roles SF and Activities and Ability to Participate in Social Roles and Activities SF.
Change from Day 1 of QOL in Quality of Life in NeuroQOL
Time frame: Up to 12 Months
A self-reported health-related quality of life (HRQL) assessment for adults with a neurological disorder, which measures 3 areas: physical health, mental health, and social health. All NeuroQOL items have 5 response options (1 = not at all to 5 = very much). Higher scores represent more impairment or worse health. Participants with bvFTD will complete the following sections of the NeuroQOL: Cognitive Function SF, Emotional and Behavioral Dyscontrol SF and Ability to Participate in Social Roles and Activities SF. Caregivers will complete the following sections of the NeuroQOL: Satisfaction with Social Roles SF and Activities and Ability to Participate in Social Roles and Activities SF.
Actual values from Day 1 of QOL in EuroOol 5 Dimensions Questionnaire (EQ-5D)
Time frame: Up to 12 Months
A self-reported generic HRQL assessment with 2 parts, the first containing 5 tick boxes (no problems, some problems, moderate problems, severe problems, cannot do) to select the most appropriate statement on each of its 5 domains (mobility, self care, usual activities, anxiety/ depression, and pain), and the second with a visual analogue scale ranging from "the best health you can imagine" to "the worst health you can imagine". This version with 5 response levels is called the EQ-5D-5L.
Change from Day 1 of QOL in EQ-5D
Time frame: Up to 12 Months
A self-reported generic HRQL assessment with 2 parts, the first containing 5 tick boxes (no problems, some problems, moderate problems, severe problems, cannot do) to select the most appropriate statement on each of its 5 domains (mobility, self care, usual activities, anxiety/ depression, and pain), and the second with a visual analogue scale ranging from "the best health you can imagine" to "the worst health you can imagine". This version with 5 response levels is called the EQ-5D-5L.
Actual values from Day 1 of QOL in Affect and Activity Indicators of QOL (AAIQOL)
Time frame: Up to 12 Months
A measure of caregiver-reported (proxy) QOL in participants with dementia which assesses 2 domains: activity and affect. Activity is a 15-item questionnaire rated on opportunity (no/yes), frequency (none/few/often), and enjoyment (yes/no), with 5 items for outdoors activities and 10 items for home activities. Affect is a 6-item questionnaire, with 3 items for positive effects and 3 items for negative effects, referring to the previous 2 weeks, and scored on a 5-point Likert scale (1 = never to 5 = several [3+] times per day).
Change from Day 1 of QOL in AAIQOL
Time frame: Up to 12 Months
A measure of caregiver-reported (proxy) QOL in participants with dementia which assesses 2 domains: activity and affect. Activity is a 15-item questionnaire rated on opportunity (no/yes), frequency (none/few/often), and enjoyment (yes/no), with 5 items for outdoors activities and 10 items for home activities. Affect is a 6-item questionnaire, with 3 items for positive effects and 3 items for negative effects, referring to the previous 2 weeks, and scored on a 5-point Likert scale (1 = never to 5 = several [3+] times per day).
Actual values from Day 1 for exploratory biomarkers
Time frame: Baseline, Month 12
Venipuncture for collection of whole blood samples for exploratory blood biomarkers analyses.
Change from Day 1 for exploratory blood biomarkers
Time frame: Baseline, Month 12
Venipuncture for collection of whole blood samples for exploratory blood biomarkers analyses.
bvFTD genetic mutations identification in whole blood samples
Time frame: Baseline, Month 12
Venipuncture for collection of whole blood samples for identification of bvFTD genetic mutations.
Potential identification of genetic biomarkers associated with bvFTD from DNA/RNA in whole blood samples
Time frame: Baseline, Month 12
Venipuncture for collection of whole blood samples for potential identification of genetic biomarkers associated with bvFTD.
Actual values at Day 1 in Clinical Global Impression of Severity (CGIS)
Time frame: Day 1
This is one of the items of the Clinical Global Impression, and measures clinical severity at baseline. It is rated on a 7-point Likert scale, with illness being rated in the range of 1 (normal) to 7 (severely ill). It requires the clinician to rate the severity of the participant's illness at the time of the assessment, relative to the clinician's past experience with participants who have the same diagnosis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frontotemporal Dementia and Behavioral Variant Frontotemporal Dementia, run by Biogen at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualized rate of change in International Shopping List Test (ISLT) - Immediate Recall (time frame: Up to 12 Months). The study lists 61 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.