Suspected Chronic Traumatic Encephalopathy (CTE) or Traumatic Encephalopathy Syndrome (TES)FDDNPNCT04311281
FDDNP Protocol for Visualizing Brain Proteinopathies to Assist in the Diagnosis of Persons With Suspected CTE and AD
An observational study of Suspected Chronic Traumatic Encephalopathy (CTE) or Traumatic Encephalopathy Syndrome (TES) and Suspected Alzheimer's Disease (AD), run by University of California, Los Angeles.
Trial summary
The primary objective of this study is to demonstrate the safety and efficacy of positron emission tomography (PET) imaging with a radioactive compound called [F-18]FDDNP in subjects with suspected Alzheimer's disease or suspected chronic traumatic encephalopathy (CTE) to predict clinical decline after one and two… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Suspected Chronic Traumatic Encephalopathy (CTE) or Traumatic Encephalopathy Syndrome (TES), Suspected Alzheimer's Disease (AD)
- What is being tested?
- [F-18]FDDNP-PET
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2021to 3 May 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: We will recruit participants with mild cognitive impairment and suspected CTE or suspected AD.
Who may be able to join
- Participants enrolling in the trial must meet all of the following criteria:
- Participant may be male or female and of any race/ethnicity
- Age 18 to 80 years at the time of study drug dosing
- Female participants must be either surgically sterilized or post-menopausal, defined as at least one-year without menses as reported by the participant or have a negative serum pregnancy test
- Participant or participant's legally acceptable representative (when appropriate) provides informed consent
- Participant is capable of complying with study procedures
Show all 31Show fewer
- Participant is capable of communicating with study personnel
- Participant is willing to undergo longitudinal follow-up at 1 and 2 years after the Imaging Visit
- All participants will meet criteria for mild cognitive impairment (Petersen et al, 2014) or Mild Neurocognitive Disorder (APA, 2013):
- Patient awareness of a memory problem, preferably confirmed by another person who knows the patient
- Memory impairment detected with standard assessment tests
- Ability to perform normal daily activities
- For a broad definition of mild cognitive impairment, we also use guidelines to identify those with other mild cognitive impairment subtypes, including those with memory impairment and/or additional cognitive deficits (Winblad et al, 2004). The diagnosis will be corroborated by clinical judgment and include participants who score 1 standard deviation or more below the age-corrected norms because this threshold for impairment yields high sensitivity for predicting dementia (de Jager et al, 2005). To balance increased sensitivity with specificity, impairment on at least 2 neuropsychological tests will be required (Jak et al., 2009).
- Participants with suspected CTE enrolling in the trial must meet all of the following criteria:
- Participant must meet the most recently proposed clinical criteria for suspected CTE (termed possible traumatic encephalopathy syndrome or TES; Reams et al, 2016). These proposed diagnostic criteria for possible TES include the following features:
- Required Features:
- Persistence of symptoms for longer than 2 years; no other neurologic disorder that is more likely to account for all the clinical features; history of head trauma exposure; progressive course; and at least 1 supportive feature
- History of head trauma exposure, typically associated with history of concussion, although may be limited to subconcussive trauma
- Head trauma exposure is repetitive in nature
- Demonstrated progressive course
- Delayed symptom onset
- Self-report or observer report of cognitive dysfunction, confirmed with objective cognitive decline documented by results of formal neuropsychological testing. Cognitive decline typically affects more than 1 domain (executive, visuospatial, memory, and language).
- Supportive Features (only 1 required):
- Emotional dysregulation: including depression, anxiety, agitation, aggression, paranoid ideation, deterioration of interpersonal relationships, and suicidality
- Behavioral change: including violence, poor impulse control, socially inappropriate behavior, avolition, apathy, change in personality, and comorbid substance abuse
- Motor disturbance: including bradykinesia, tremor, rigidity, gait instability, dysarthria, dysphagia, and ataxia
- Participants with suspected AD enrolling in the trial must meet all of the following criteria:
- Cognitive deficits do not occur exclusively in the context of a delirium.
- Cognitive deficits are not better explained by another mental disorder (e.g., major depressive disorder, schizophrenia).
- There is insidious onset and gradual progression of impairment in one or more cognitive domains.
- The participant has documented memory problems in one or more other cognitive domains, such as language, visual-spatial functioning, executive functioning, etc. (Busse et al., 2006).
Who cannot join
- Participants meeting any of the following criteria will not be enrolled in the study:
- Participant is pregnant or nursing
- Phone screen of Telephone Interview for Cognitive Status-modified (TICS-M) ≥ 33
- Participant unable to remain still for duration of imaging procedure or has an inability to tolerate neuropsychological, clinical, or PET scan studies (e.g., head tremor that may cause head motion artifact, uncontrollable psychosis, acute suicidality)
- Participant has prior history of stroke or other condition of the head or neck that, in the investigator's opinion, might affect circulation to the head or image interpretation
- Preexisting major neurologic or other physical illness that could confound results (e.g., multiple sclerosis, diabetes, cancer)
Show all 17Show fewer
- Participant has a major psychiatric disorder such as mania or schizophrenia, which might interfere with completing study procedures (APA, 2013)
- Participant has a psychiatric disorder, such as anxiety or depression, severe enough to interfere with completing study procedures
- Participant has a condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete accurate quality data
- Participant has a history of significant prescription drug, non-prescription drug, or alcohol abuse, including but not limited to marijuana, cocaine, heroin or derivatives
- Participant has previously received [F-18]FDDNP at any time, or any other investigational product within the past thirty days
- Participant has a history of allergic reactions to albumin
- Participant has severe anemia in which case the use of albumin would be medically contraindicated
- Participant has cardiac failure in which case the use of albumin would be contraindicated
- Participant has unstable cardiac disease or uncontrolled hypertension (systolic BP > 170 or diastolic BP > 100)
- Participants taking ibuprofen or naproxen will be asked to stop taking the medication for five days before the PET scan since these medicines may affect [F-18]FDDNP-PET scan results. Other anti-inflammatory medicines, such as diclofenac or aspirin, can be substituted during that period. If the participant cannot temporarily discontinue the medicine, that participant will be excluded from the study
- Participant has used of any investigational drugs within the previous month or has participated in imaging or other clinical research protocols that might confound study results
About this study
Official title: [F-18] FDDNP-PET Clinical Protocol for Visualizing Brain Proteinopathies to Assist in the Diagnosis of Persons With Suspected Chronic Traumatic Encephalopathy and Alzheimer's Disease
The primary objective of this study is to demonstrate the safety and efficacy of positron emission tomography (PET) imaging with a radioactive compound called [F-18]FDDNP in subjects with suspected Alzheimer's disease or suspected chronic traumatic encephalopathy (CTE) to predict clinical decline after one and two years.
Read the detailed description
The investigators will enroll approximately 180 participants with mild cognitive impairment (90 with suspected Alzheimer's Disease and 90 with suspected Chronic Traumatic Encephalopathy with a history of head trauma).
Participants will come to UCLA for 4 visits and will be called twice. The study duration is 2 years.
Participants will first complete an over the phone screening to assess their eligibility. If they pass the phone screen, then they will be invited to complete an in-person screen and will sign the informed consent form. They will then undergo a neurological evaluation, blood draw, and neuropsychological testing.
Within a month of the screening visit, participants will complete the imaging visit. Participants will undergo a magnetic resonance imaging (MRI) scan, if eligible, and a PET scan with FDDNP. For participants who are unable to undergo an MRI due to contraindications, they will complete a CT scan.
Participants will be monitored for possible adverse events following the procedures and will be called 24 hours later and 2 weeks later to assess for any potential adverse events.
At the one and two-year follow-up visits, participants' medical history will be reviewed. At this time, they will also complete a neuropsychiatric evaluation, blood draw and neuropsychological testing.
Prediction of clinical and cognitive decline from [F-18] FDDNP PET scan readers (blinded to clinical evaluations) and clinicians (blinded to [F-18]FDDNP PET scan results) will be compared with actual clinical outcomes determined at one and two-year follow-up visits.
- Conditions
- Suspected Chronic Traumatic Encephalopathy (CTE) or Traumatic Encephalopathy Syndrome (TES), Suspected Alzheimer's Disease (AD)
- Being tested
- [F-18]FDDNP-PET
- Keywords
- [F-18] FDDNP-PET, Alzheimer's disease (AD), beta amyloid, tau, positron emission tomography, chronic traumatic encephalopathy (CTE), traumatic encephalopathy syndrome (TES)
- Medical subject headings
- Alzheimer Disease, Plaque, Amyloid, Pick Disease of the Brain, Chronic Traumatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[F-18]FDDNP-PETBiological
[F-18]FDDNP, or 2-(1-{6-[(2-[F-18]fluoroethyl)(methyl)amino]-2- naphthyl}ethylidene)malononitrile, is a positron emission tomography (PET) radiotracer developed for the in vivo visualization of tau and amyloid-beta (Aβ) deposition in the brain.
| Study group | Role | What they receive |
|---|---|---|
| Suspected AD | Participants with suspected AD enrolling in the trial must meet all of the following criteria:
* Cognitive deficits do not occur exclusively in the context of a delirium.
* Cognitive deficits are not better explained by another mental disorder (e.g., major depressive disorder, schizophrenia).
* There is insidious onset and gradual progression of impairment in one or more cognitive domains.
* The participant has documented memory problems in one or more other cognitive domains, such as language, visual-spatial functioning, executive functioning, etc. (Busse et al., 2006). Receives: Biological: [F-18]FDDNP-PET | |
| Suspected CTE / TES | Required Features:
* Persistence of symptoms for longer than 2 years; no other neurologic disorder that is more likely to account for all the clinical features; history of head trauma exposure; progressive course; and at least 1 supportive feature
* History of head trauma exposure, typically associated with history of concussion, although may be limited to subconcussive trauma
* Head trauma exposure is repetitive in nature
* Demonstrated progressive course
* Delayed symptom onset
* Self-report or observer report of cognitive dysfunction, confirmed with objective cognitive decline documented by results of formal neuropsychological testing. Cognitive decline typically affects more than 1 domain (executive, visuospatial, memory, and language).
Supportive Features (only 1 required):
* Emotional dysregulation
* Behavioral change
* Motor disturbance Receives: Biological: [F-18]FDDNP-PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Dementia Rating Sum of Box Scores (CDR-SB)
We propose to use the CDR Sum of Box Scores (CDR-SB) as the primary efficacy endpoint to be predicted (at two-year follow-up) following baseline when the [F-18]FDDNP-PET imaging is performed. The CDR-SB score is obtained by summing each of the domain box scores, with scores ranging from 0 to 18. We will use change in CDR-SB score as the common outcome variable. We will convert individual CDR-SB scores into standardized scores by subtracting the baseline mean and dividing by the baseline standard deviation of the study sample (Monsell et al, 2012). Individuals experiencing worsening of cognition by at least 0.5 standard deviation per year in the standardized CDR-SB score will be classified as cognitive decliners; others will be classified as cognitive maintainers.
Measured: 2 years
Secondary outcomes (2)
Change in Executive Functioning Domain Score
Calculated as the average of z- transformed scores of: Trails B-A, Category Fluency, Letter Fluency, and Wechsler Adult Intelligence Scale-IV Digit Symbol and Digit Span backwards (Harrison et al., 2007).
Measured: 2 years
Conversion to Dementia
For a dementia diagnosis, we will use major neurocognitive disorder according to the Diagnostic and Statistical Manual-5 [DSM-5] criteria (APA, 2013; Csukly et al, 2016).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study startMay 2021 (estimated)
- Primary completion3 May 2021
- Study completion3 May 2021
Why it stopped: Insufficient Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Suspected Chronic Traumatic Encephalopathy (CTE) or Traumatic Encephalopathy Syndrome (TES)Studies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helen Lavretsky, MD, University of California, Los Angeles
- Investigators
- Helen Lavretsky, MD, Principal investigator, University of California, Los Angeles, Semel Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311281
- Sponsor's protocol ID
- 18-001176
- Acronym
- FDDNP
- Status last verified
- May 2021
- First submitted
- 12 Mar 2020
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Washington, DC: American Psychiatric Association, 2013.
Busse A, Hensel A, Guhne U, Angermeyer MC, Riedel-Heller SG. Mild cognitive impairment: long-term course of four clinical subtypes. Neurology. 2006 Dec 26;67(12):2176-85. doi: 10.1212/01.wnl.0000249117.23318.e1.
PubMed 17190940Csukly G, Siraly E, Fodor Z, Horvath A, Salacz P, Hidasi Z, Csibri E, Rudas G, Szabo A. The Differentiation of Amnestic Type MCI from the Non-Amnestic Types by Structural MRI. Front Aging Neurosci. 2016 Mar 30;8:52. doi: 10.3389/fnagi.2016.00052. eCollection 2016.
PubMed 27065855de Jager CA, Budge MM. Stability and predictability of the classification of mild cognitive impairment as assessed by episodic memory test performance over time. Neurocase. 2005 Feb;11(1):72-9. doi: 10.1080/13554790490896820.
PubMed 15804927Harrison J, Minassian SL, Jenkins L, Black RS, Koller M, Grundman M. A neuropsychological test battery for use in Alzheimer disease clinical trials. Arch Neurol. 2007 Sep;64(9):1323-9. doi: 10.1001/archneur.64.9.1323.
PubMed 17846273Hyman BT, Phelps CH, Beach TG, Bigio EH, Cairns NJ, Carrillo MC, Dickson DW, Duyckaerts C, Frosch MP, Masliah E, Mirra SS, Nelson PT, Schneider JA, Thal DR, Thies B, Trojanowski JQ, Vinters HV, Montine TJ. National Institute on Aging-Alzheimer's Association guidelines for the neuropathologic assessment of Alzheimer's disease. Alzheimers Dement. 2012 Jan;8(1):1-13. doi: 10.1016/j.jalz.2011.10.007.
PubMed 22265587Jak AJ, Bondi MW, Delano-Wood L, Wierenga C, Corey-Bloom J, Salmon DP, Delis DC. Quantification of five neuropsychological approaches to defining mild cognitive impairment. Am J Geriatr Psychiatry. 2009 May;17(5):368-75. doi: 10.1097/JGP.0b013e31819431d5.
PubMed 19390294Monsell SE, Liu D, Weintraub S, Kukull WA. Comparing measures of decline to dementia in amnestic MCI subjects in the National Alzheimer's Coordinating Center (NACC) Uniform Data Set. Int Psychogeriatr. 2012 Oct;24(10):1553-60. doi: 10.1017/S1041610212000452. Epub 2012 Apr 16.
PubMed 22717299Petersen RC, Caracciolo B, Brayne C, Gauthier S, Jelic V, Fratiglioni L. Mild cognitive impairment: a concept in evolution. J Intern Med. 2014 Mar;275(3):214-28. doi: 10.1111/joim.12190.
PubMed 24605806Reams N, Eckner JT, Almeida AA, Aagesen AL, Giordani B, Paulson H, Lorincz MT, Kutcher JS. A Clinical Approach to the Diagnosis of Traumatic Encephalopathy Syndrome: A Review. JAMA Neurol. 2016 Jun 1;73(6):743-9. doi: 10.1001/jamaneurol.2015.5015.
PubMed 27111824Winblad B, Palmer K, Kivipelto M, Jelic V, Fratiglioni L, Wahlund LO, Nordberg A, Backman L, Albert M, Almkvist O, Arai H, Basun H, Blennow K, de Leon M, DeCarli C, Erkinjuntti T, Giacobini E, Graff C, Hardy J, Jack C, Jorm A, Ritchie K, van Duijn C, Visser P, Petersen RC. Mild cognitive impairment--beyond controversies, towards a consensus: report of the International Working Group on Mild Cognitive Impairment. J Intern Med. 2004 Sep;256(3):240-6. doi: 10.1111/j.1365-2796.2004.01380.x.
PubMed 15324367
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [F-18] FDDNP-PET Clinical Protocol for Visualizing Brain Proteinopathies to Assist in the Diagnosis of Persons With Suspected Chronic Traumatic Encephalopathy and Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04311281
- Acronym / sponsor ID
- FDDNP / 18-001176
- Conditions
- Suspected Chronic Traumatic Encephalopathy (CTE) or Traumatic Encephalopathy Syndrome (TES), Suspected Alzheimer's Disease (AD)
- Keywords
- [F-18] FDDNP-PET, Alzheimer's disease (AD), beta amyloid, tau, positron emission tomography, chronic traumatic encephalopathy (CTE), traumatic encephalopathy syndrome (TES)
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Insufficient Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- 3 May 2021 (actual)
- Study completion
- 3 May 2021 (actual)
- First posted
- 17 Mar 2020 (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 primary objective of this study is to demonstrate the safety and efficacy of positron emission tomography (PET) imaging with a radioactive compound called [F-18]FDDNP in subjects with suspected Alzheimer's disease or suspected chronic traumatic encephalopathy (CTE) to predict clinical decline after one and two years.
Detailed description
The investigators will enroll approximately 180 participants with mild cognitive impairment (90 with suspected Alzheimer's Disease and 90 with suspected Chronic Traumatic Encephalopathy with a history of head trauma).
Participants will come to UCLA for 4 visits and will be called twice. The study duration is 2 years.
Participants will first complete an over the phone screening to assess their eligibility. If they pass the phone screen, then they will be invited to complete an in-person screen and will sign the informed consent form. They will then undergo a neurological evaluation, blood draw, and neuropsychological testing.
Within a month of the screening visit, participants will complete the imaging visit. Participants will undergo a magnetic resonance imaging (MRI) scan, if eligible, and a PET scan with FDDNP. For participants who are unable to undergo an MRI due to contraindications, they will complete a CT scan.
Participants will be monitored for possible adverse events following the procedures and will be called 24 hours later and 2 weeks later to assess for any potential adverse events.
At the one and two-year follow-up visits, participants' medical history will be reviewed. At this time, they will also complete a neuropsychiatric evaluation, blood draw and neuropsychological testing.
Prediction of clinical and cognitive decline from [F-18] FDDNP PET scan readers (blinded to clinical evaluations) and clinicians (blinded to [F-18]FDDNP PET scan results) will be compared with actual clinical outcomes determined at one and two-year follow-up visits.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suspected AD | – | Biological: [F-18]FDDNP-PETParticipants with suspected AD enrolling in the trial must meet all of the following criteria: * Cognitive deficits do not occur exclusively in the context of a delirium. * Cognitive deficits are not better explained by another mental disorder (e.g., major depressive disorder, schizophrenia). * There is insidious onset and gradual progression of impairment in one or more cognitive domains. * The participant has documented memory problems in one or more other cognitive domains, such as language, visual-spatial functioning, executive functioning, etc. (Busse et al., 2006). |
| Suspected CTE / TES | – | Biological: [F-18]FDDNP-PETRequired Features: * Persistence of symptoms for longer than 2 years; no other neurologic disorder that is more likely to account for all the clinical features; history of head trauma exposure; progressive course; and at least 1 supportive feature * History of head trauma exposure, typically associated with history of concussion, although may be limited to subconcussive trauma * Head trauma exposure is repetitive in nature * Demonstrated progressive course * Delayed symptom onset * Self-report or observer report of cognitive dysfunction, confirmed with objective cognitive decline documented by results of formal neuropsychological testing. Cognitive decline typically affects more than 1 domain (executive, visuospatial, memory, and language). Supportive Features (only 1 required): * Emotional dysregulation * Behavioral change * Motor disturbance |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will recruit participants with mild cognitive impairment and suspected CTE or suspected AD.
Key inclusion criteria (31 listed)
- Participant may be male or female and of any race/ethnicity
- Age 18 to 80 years at the time of study drug dosing
- Female participants must be either surgically sterilized or post-menopausal, defined as at least one-year without menses as reported by the participant or have a negative serum pregnancy test
- Participant or participant's legally acceptable representative (when appropriate) provides informed consent
- Participant is capable of complying with study procedures
Key exclusion criteria (17 listed)
- Participant is pregnant or nursing
- Phone screen of Telephone Interview for Cognitive Status-modified (TICS-M) ≥ 33
- Participant unable to remain still for duration of imaging procedure or has an inability to tolerate neuropsychological, clinical, or PET scan studies (e.g., head tremor that may cause head motion artifact, uncontrollable psychosis, acute suicidality)
- Participant has prior history of stroke or other condition of the head or neck that, in the investigator's opinion, might affect circulation to the head or image interpretation
- Preexisting major neurologic or other physical illness that could confound results (e.g., multiple sclerosis, diabetes, cancer)
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 |
|---|---|---|
| [F-18]FDDNP-PET[F-18]FDDNP, or 2-(1-{6-[(2-[F-18]fluoroethyl)(methyl)amino]-2- naphthyl}ethylidene)malononitrile, is a positron emission tomography (PET) radiotracer developed for the in vivo visualization of tau and amyloid-beta (Aβ) deposition in the brain. | Biological | Suspected AD, Suspected CTE / TES |
Primary outcome
Clinical Dementia Rating Sum of Box Scores (CDR-SB)
Time frame: 2 years
We propose to use the CDR Sum of Box Scores (CDR-SB) as the primary efficacy endpoint to be predicted (at two-year follow-up) following baseline when the [F-18]FDDNP-PET imaging is performed. The CDR-SB score is obtained by summing each of the domain box scores, with scores ranging from 0 to 18. We will use change in CDR-SB score as the common outcome variable. We will convert individual CDR-SB scores into standardized scores by subtracting the baseline mean and dividing by the baseline standard deviation of the study sample (Monsell et al, 2012). Individuals experiencing worsening of cognition by at least 0.5 standard deviation per year in the standardized CDR-SB score will be classified as cognitive decliners; others will be classified as cognitive maintainers.
2 secondary outcomes
Change in Executive Functioning Domain Score
Time frame: 2 years
Conversion to Dementia
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- BackgroundAmerican Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Washington, DC: American Psychiatric Association, 2013.
- Background: PubMed 17190940Busse A, Hensel A, Guhne U, Angermeyer MC, Riedel-Heller SG. Mild cognitive impairment: long-term course of four clinical subtypes. Neurology. 2006 Dec 26;67(12):2176-85. doi: 10.1212/01.wnl.0000249117.23318.e1.
- Background: PubMed 27065855Csukly G, Siraly E, Fodor Z, Horvath A, Salacz P, Hidasi Z, Csibri E, Rudas G, Szabo A. The Differentiation of Amnestic Type MCI from the Non-Amnestic Types by Structural MRI. Front Aging Neurosci. 2016 Mar 30;8:52. doi: 10.3389/fnagi.2016.00052. eCollection 2016.
- Background: PubMed 15804927de Jager CA, Budge MM. Stability and predictability of the classification of mild cognitive impairment as assessed by episodic memory test performance over time. Neurocase. 2005 Feb;11(1):72-9. doi: 10.1080/13554790490896820.
- Background: PubMed 17846273Harrison J, Minassian SL, Jenkins L, Black RS, Koller M, Grundman M. A neuropsychological test battery for use in Alzheimer disease clinical trials. Arch Neurol. 2007 Sep;64(9):1323-9. doi: 10.1001/archneur.64.9.1323.
- Background: PubMed 22265587Hyman BT, Phelps CH, Beach TG, Bigio EH, Cairns NJ, Carrillo MC, Dickson DW, Duyckaerts C, Frosch MP, Masliah E, Mirra SS, Nelson PT, Schneider JA, Thal DR, Thies B, Trojanowski JQ, Vinters HV, Montine TJ. National Institute on Aging-Alzheimer's Association guidelines for the neuropathologic assessment of Alzheimer's disease. Alzheimers Dement. 2012 Jan;8(1):1-13. doi: 10.1016/j.jalz.2011.10.007.
- Background: PubMed 19390294Jak AJ, Bondi MW, Delano-Wood L, Wierenga C, Corey-Bloom J, Salmon DP, Delis DC. Quantification of five neuropsychological approaches to defining mild cognitive impairment. Am J Geriatr Psychiatry. 2009 May;17(5):368-75. doi: 10.1097/JGP.0b013e31819431d5.
- Background: PubMed 22717299Monsell SE, Liu D, Weintraub S, Kukull WA. Comparing measures of decline to dementia in amnestic MCI subjects in the National Alzheimer's Coordinating Center (NACC) Uniform Data Set. Int Psychogeriatr. 2012 Oct;24(10):1553-60. doi: 10.1017/S1041610212000452. Epub 2012 Apr 16.
- Background: PubMed 24605806Petersen RC, Caracciolo B, Brayne C, Gauthier S, Jelic V, Fratiglioni L. Mild cognitive impairment: a concept in evolution. J Intern Med. 2014 Mar;275(3):214-28. doi: 10.1111/joim.12190.
- Background: PubMed 27111824Reams N, Eckner JT, Almeida AA, Aagesen AL, Giordani B, Paulson H, Lorincz MT, Kutcher JS. A Clinical Approach to the Diagnosis of Traumatic Encephalopathy Syndrome: A Review. JAMA Neurol. 2016 Jun 1;73(6):743-9. doi: 10.1001/jamaneurol.2015.5015.
- Background: PubMed 15324367Winblad B, Palmer K, Kivipelto M, Jelic V, Fratiglioni L, Wahlund LO, Nordberg A, Backman L, Albert M, Almkvist O, Arai H, Basun H, Blennow K, de Leon M, DeCarli C, Erkinjuntti T, Giacobini E, Graff C, Hardy J, Jack C, Jorm A, Ritchie K, van Duijn C, Visser P, Petersen RC. Mild cognitive impairment--beyond controversies, towards a consensus: report of the International Working Group on Mild Cognitive Impairment. J Intern Med. 2004 Sep;256(3):240-6. doi: 10.1111/j.1365-2796.2004.01380.x.
- Individual participant dataSharing planned: Yes
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.
Helen Lavretsky, MD principal investigator
University of California, Los Angeles, Semel Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Suspected Chronic Traumatic Encephalopathy (CTE) or Traumatic Encephalopathy Syndrome (TES) and Suspected Alzheimer's Disease (AD), run by University of California, Los Angeles.
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 31 inclusion and 17 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: withdrawn, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Clinical Dementia Rating Sum of Box Scores (CDR-SB) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04311281, which also lists 11 linked publications.
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 6 May 2021.