Alzheimers DiseaseNCT05097131
An Observational Study of Aducanumab-avwa in Participants With Alzheimer's Disease in the US
An observational study of Alzheimers Disease, run by Biogen at 22 sites in United States.
Trial summary
This is a prospective, single-arm, multicenter, non-interventional study of aducanumab-avwa as prescribed in the post-marketing setting in the US. Investigators will be prescribing aducanumab-avwa and participants will be treated according to the standard of care (SoC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimers Disease
- How many people
- 29 participants
- Where
- 22 sitesUnited States
- Study dates
- 18 Nov 2021to 20 May 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who have been prescribed with aducanumab-avwa in the post-marketing setting according to standard care of practice.
Who may be able to join
- Participant has a diagnosis of Alzheimer's Disease (AD) and is prescribed aducanumab-avwa by their treating physician.
- Participant's treating physician has made the decision to initiate aducanumab-avwa prior to participant inclusion and independently of the purpose of the study.
Who cannot join
- Participant concurrently participates in any interventional clinical study.
- Participant has ever been treated with aducanumab-avwa at a dose of 3 milligrams per kilogram (mg/kg) or greater prior to signing ICF.
- Participant has ever been treated with aducanumab-avwa and discontinued treatment prior to signing ICF.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Abington Neurological Associates
Abington, Pennsylvania, 19001
Carolina Clinical Research & Consulting, LLC
Asheboro, North Carolina, 27204
The Memory Clinic
Bennington, Vermont, 05201
Research Site
Boca Raton, Florida, 33487
Research Site
Bradenton, Florida, 34205
Research Site
Canton, Ohio, 44718
Dayton Center for Neurological Associates
Centerville, Ohio, 45459
Northwest Neurology
Chicago, Illinois, 60631
Research Site
Chula Vista, California, 91910
New Life Medical Research Center, Inc
Hialeah, Florida, 33012
Genesis Neuroscience Clinic
Knoxville, Tennessee, 37909
Las Vegas Medical Research
Las Vegas, Nevada, 89128
Research Site
Matthews, North Carolina, 28105
Miami Jewish Health System, Inc
Miami, Florida, 33180
Research Site
Ozark, Missouri, 65721
Imic, Inc.
Palmetto Bay, Florida, 33157
South Shore Neurologic Associates, P.A.
Patchogue, New York, 11772
Neurostudies, Inc
Port Charlotte, Florida, 33952
Coastal Neurology, PA
Port Royal, South Carolina, 29935
Center for Cognitive Health
Portland, Oregon, 97225
Mehdi Meratee MD
Valencia, California, 91355
Vero Beach Neurology and Research Institute
Vero Beach, Florida, 32960
About this study
Official title: International Collaboration for Real-World Evidence in Alzheimer's Disease (ICARE AD)- A Prospective Real-World Observational Study of Aducanumab-avwa in Patients With Alzheimer's Disease in the US
This is a prospective, single-arm, multicenter, non-interventional study of aducanumab-avwa as prescribed in the post-marketing setting in the US. Investigators will be prescribing aducanumab-avwa and participants will be treated according to the standard of care (SoC). Participants will be followed up to 5 years after enrollment and data will be collected at routine visits every 6 to 12 months.
- Conditions
- Alzheimers Disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Participants who have been prescribed with aducanumab-avwa in the post-marketing setting according to standard care of practice will be enrolled. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Quick Dementia Rating Scale Informant Version & Patient Version (QDRS-IV/PV) Score
QDRS-IV /PV is rapid dementia staging tool. It is a 10-item questionnaire completed by an informant and a participant. The 10 domains covered are memory and recall, orientation, decision-making and problem-solving abilities, activities outside the home, function at home and hobbies, toileting and personal hygiene, behavior and personality changes, language and communication abilities, mood, and attention and concentration. Each domain is rated on five-point scale with increasing severity of symptoms. Total scores range from 0 to 30 with higher scores representing greater cognitive impairment.
Measured: Up to 5 years
Change from Baseline in Amsterdam Instrumental Activities of Daily Living Questionnaire Short Version (A-IADL-Q-SV) Score
A-IADL-Q-SV is used to measure activities of daily living (ADL) in earliest stages of dementia. It consist of 30 items in 7 categories. All items are rated on a five-point scale, ranging from 'no difficulty' to 'unable to perform'. Scoring is based on item response theory (IRT). A-IADL-Q-SV meet all the basic assumptions of IRT scoring, based on a Graded Response Model: (1) Unidimensionality, which implies that one underlying latent trait determines the items; (2) Local independence, meaning the independence of item responses, conditional on the latent trait; and (3) Monotonicity, meaning the probability of endorsing higher item categories as the trait level increases. The IRT latent trait levels are transformed into a 'T-score' with a range from approximately 20 to 80, a mean of 50 and a standard deviation of 10, with higher 'T-scores' indicating better IADL functioning.
Measured: Up to 5 years
Change from Baseline in Functional Activities Questionnaire (FAQ) Score
FAQ is 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). Total score ranges from 0 to 30 with higher scores indicating more impairment.
Measured: Up to 5 years
Change from Baseline in Montreal Cognitive Assessment Version 8.1 (MoCA v8.1) Score
It is used to detect mild cognitive dysfunction. It assesses 30 items in different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total score ranges from 0-30 with lower score indicating poor performance.
Measured: Up to 5 years
Change from Baseline in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score
The NPI-Q assesses twelve behavioral domains common in dementia including; hallucinations, delusions, agitation/aggression, dysphoria/depression, anxiety, irritability, disinhibition, euphoria, apathy, aberrant motor behavior, sleep/night-time behavior change, and appetite/eating change. The questionnaire is given by the clinician to the patient's caregiver who is asked if the behavior described is present in the patient. If "Yes", the informant then rates both the Severity of the symptoms present within the last month on a 3-point scale (1 = mild, 2= moderate, and 3= severe) and the associated impact of the symptom manifestations on them (i.e. Caregiver Distress) using a 5-point scale (0 = not distressing at all, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = extreme or very severe). The total severity score represents the sum of individual scores and ranges from 0 to 36. The total distress score represents the sum of individual symptom scores and ranges from 0 to 60.
Measured: Baseline up to 5 years
Change from Baseline in Geriatric Depression Scale Short Form (GDS-SF) Score
This is the screening test for depression in elderly people. The questionnaire contains 15 items. Participants indicate the presence or absence of each symptom. The GDS-SF score is the total number of positive depressive items. Score range is from 0-15. Scores of 0-4 are considered normal, 5-8 indicate mild depression, 9-11 indicate moderate depression and 12-15 indicate severe depression.
Measured: Up to 5 years
Change from Baseline in 13-Item Quality of Life in Alzheimer's Disease (QoL-AD) Score
The scale includes 13 items of life domains including the participant's physical health, mood, relationships, activities, and ability to complete tasks. Each item is scored using a scale of 1-4 (poor, fair, good, or excellent). Total score ranges 13-52; higher scores indicate better QOL.
Measured: Up to 5 years
Change from Baseline in Zarit Burden Interview (22-Item) Score
This assesses the level of burden experienced by the principal caregivers of older participants with senile dementia and disabled participants. It consists of 22 items rated on a 5-point Likert scale that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0-88. Higher scores indicate greater burden.
Measured: Up to 5 years
Change from Baseline in Short Form 12 Version 2 (SF-12v2) Score
It is an alternative to Short Form 36 (SF-36®) for use in large surveys of general and specific populations as well as large longitudinal studies of health outcomes. It consists of eight subscale scores (physical functioning [PF], role-physical [RP], bodily pain [BP], general health [GH], vitality [VT], social functioning [SF], role-emotional [RE], and mental health [MH]). Total score ranges from 0 to 100. Higher scores indicate better health status.
Measured: Up to 5 years
Change from Baseline in Health Care Resource Utilization (HCRU) Using Resource Utilization in Dementia Lite (RUD Lite)
Measures HCRU among older adults with dementia and their caregivers, and time spent on formal and informal care by caregivers. This questionnaire is not scored, it provides information, such as, hospitalizations, time spent assisting with personal ADLs, time spent supervising the participant, social services.
Measured: Up to 5 years
Change form Baseline in Patient Global Impressions Scale of Severity (PGI-S) Score
PGI-S evaluates the severity of participant's condition. PGI -S is a 1-item questionnaire where the response is recorded on a 4-point scale scored as: "normal" (1), "mild" (2), "moderate" (3), or "severe" (4).
Measured: Up to 5 years
Change from Baseline in Patient Global Impression of Change (PGI -C) Score
PGI-C is a 7-point self-administered scale that assesses if there has been a change in the participant's health over time. Participants will rate their change as "1=very much improved," "2=much improved," "3=minimally improved," "4=no change," "5=minimally worse," "6=much worse," or "7=very much worse".
Measured: Up to 5 years
Secondary outcomes (2)
The Number of Participants With Adverse Events (AEs), Including Amyloid-Related Imaging Abnormality (ARIA), andSerious Adverse Events (SAEs) in Aducanumab-avwa-treated Participants in Real-world Per Label Recommendation
An AE can be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of amedicinal product, whether or not related to the medicinal product. An SAE is any untoward medical occurrence thatat any dose: results in death, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event) requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent orsignificant disability/incapacity, results in a congenital anomaly/birth defect, is a medically important event.
Measured: Up to 5 years
To Obtain Descriptive Statistics on the Characteristics of the Aducanumab-avwa User Population and on Drug Utilization
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start18 Nov 2021
- Primary completion20 May 2022
- Study completion20 May 2022
Why it stopped: As a result of the national policy for coverage, it is expected there will be limited aducanumab-avwa prescription and usage in routine clinical practice making the study not feasible for enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimers DiseaseStudies 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
- 29 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
- NCT05097131
- Sponsor's protocol ID
- US-ALZ-11855
- Status last verified
- Apr 2023
- First submitted
- 30 Sep 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Collaboration for Real-World Evidence in Alzheimer's Disease (ICARE AD)- A Prospective Real-World Observational Study of Aducanumab-avwa in Patients With Alzheimer's Disease in the US
- ClinicalTrials.gov ID
- NCT05097131
- Acronym / sponsor ID
- US-ALZ-11855
- Conditions
- Alzheimers Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: As a result of the national policy for coverage, it is expected there will be limited aducanumab-avwa prescription and usage in routine clinical practice making the study not feasible for enrollment.
- Enrolment
- 29 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 27 Oct 2021 (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.
This is a prospective, single-arm, multicenter, non-interventional study of aducanumab-avwa as prescribed in the post-marketing setting in the US. Investigators will be prescribing aducanumab-avwa and participants will be treated according to the standard of care (SoC). Participants will be followed up to 5 years after enrollment and data will be collected at routine visits every 6 to 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | –Participants who have been prescribed with aducanumab-avwa in the post-marketing setting according to standard care of practice will be enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who have been prescribed with aducanumab-avwa in the post-marketing setting according to standard care of practice.
Key inclusion criteria (2 listed)
- Participant has a diagnosis of Alzheimer's Disease (AD) and is prescribed aducanumab-avwa by their treating physician.
- Participant's treating physician has made the decision to initiate aducanumab-avwa prior to participant inclusion and independently of the purpose of the study.
Key exclusion criteria (4 listed)
- Participant concurrently participates in any interventional clinical study.
- Participant has ever been treated with aducanumab-avwa at a dose of 3 milligrams per kilogram (mg/kg) or greater prior to signing ICF.
- Participant has ever been treated with aducanumab-avwa and discontinued treatment prior to signing ICF.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from Baseline in Quick Dementia Rating Scale Informant Version & Patient Version (QDRS-IV/PV) Score
Time frame: Up to 5 years
QDRS-IV /PV is rapid dementia staging tool. It is a 10-item questionnaire completed by an informant and a participant. The 10 domains covered are memory and recall, orientation, decision-making and problem-solving abilities, activities outside the home, function at home and hobbies, toileting and personal hygiene, behavior and personality changes, language and communication abilities, mood, and attention and concentration. Each domain is rated on five-point scale with increasing severity of symptoms. Total scores range from 0 to 30 with higher scores representing greater cognitive impairment.
Change from Baseline in Amsterdam Instrumental Activities of Daily Living Questionnaire Short Version (A-IADL-Q-SV) Score
Time frame: Up to 5 years
A-IADL-Q-SV is used to measure activities of daily living (ADL) in earliest stages of dementia. It consist of 30 items in 7 categories. All items are rated on a five-point scale, ranging from 'no difficulty' to 'unable to perform'. Scoring is based on item response theory (IRT). A-IADL-Q-SV meet all the basic assumptions of IRT scoring, based on a Graded Response Model: (1) Unidimensionality, which implies that one underlying latent trait determines the items; (2) Local independence, meaning the independence of item responses, conditional on the latent trait; and (3) Monotonicity, meaning the probability of endorsing higher item categories as the trait level increases. The IRT latent trait levels are transformed into a 'T-score' with a range from approximately 20 to 80, a mean of 50 and a standard deviation of 10, with higher 'T-scores' indicating better IADL functioning.
Change from Baseline in Functional Activities Questionnaire (FAQ) Score
Time frame: Up to 5 years
FAQ is 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). Total score ranges from 0 to 30 with higher scores indicating more impairment.
Change from Baseline in Montreal Cognitive Assessment Version 8.1 (MoCA v8.1) Score
Time frame: Up to 5 years
It is used to detect mild cognitive dysfunction. It assesses 30 items in different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total score ranges from 0-30 with lower score indicating poor performance.
Change from Baseline in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score
Time frame: Baseline up to 5 years
The NPI-Q assesses twelve behavioral domains common in dementia including; hallucinations, delusions, agitation/aggression, dysphoria/depression, anxiety, irritability, disinhibition, euphoria, apathy, aberrant motor behavior, sleep/night-time behavior change, and appetite/eating change. The questionnaire is given by the clinician to the patient's caregiver who is asked if the behavior described is present in the patient. If "Yes", the informant then rates both the Severity of the symptoms present within the last month on a 3-point scale (1 = mild, 2= moderate, and 3= severe) and the associated impact of the symptom manifestations on them (i.e. Caregiver Distress) using a 5-point scale (0 = not distressing at all, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = extreme or very severe). The total severity score represents the sum of individual scores and ranges from 0 to 36. The total distress score represents the sum of individual symptom scores and ranges from 0 to 60.
Change from Baseline in Geriatric Depression Scale Short Form (GDS-SF) Score
Time frame: Up to 5 years
This is the screening test for depression in elderly people. The questionnaire contains 15 items. Participants indicate the presence or absence of each symptom. The GDS-SF score is the total number of positive depressive items. Score range is from 0-15. Scores of 0-4 are considered normal, 5-8 indicate mild depression, 9-11 indicate moderate depression and 12-15 indicate severe depression.
Change from Baseline in 13-Item Quality of Life in Alzheimer's Disease (QoL-AD) Score
Time frame: Up to 5 years
The scale includes 13 items of life domains including the participant's physical health, mood, relationships, activities, and ability to complete tasks. Each item is scored using a scale of 1-4 (poor, fair, good, or excellent). Total score ranges 13-52; higher scores indicate better QOL.
Change from Baseline in Zarit Burden Interview (22-Item) Score
Time frame: Up to 5 years
This assesses the level of burden experienced by the principal caregivers of older participants with senile dementia and disabled participants. It consists of 22 items rated on a 5-point Likert scale that ranges from 0 (never) to 4 (nearly always) with the sum of scores ranging between 0-88. Higher scores indicate greater burden.
Change from Baseline in Short Form 12 Version 2 (SF-12v2) Score
Time frame: Up to 5 years
It is an alternative to Short Form 36 (SF-36®) for use in large surveys of general and specific populations as well as large longitudinal studies of health outcomes. It consists of eight subscale scores (physical functioning [PF], role-physical [RP], bodily pain [BP], general health [GH], vitality [VT], social functioning [SF], role-emotional [RE], and mental health [MH]). Total score ranges from 0 to 100. Higher scores indicate better health status.
Change from Baseline in Health Care Resource Utilization (HCRU) Using Resource Utilization in Dementia Lite (RUD Lite)
Time frame: Up to 5 years
Measures HCRU among older adults with dementia and their caregivers, and time spent on formal and informal care by caregivers. This questionnaire is not scored, it provides information, such as, hospitalizations, time spent assisting with personal ADLs, time spent supervising the participant, social services.
Change form Baseline in Patient Global Impressions Scale of Severity (PGI-S) Score
Time frame: Up to 5 years
PGI-S evaluates the severity of participant's condition. PGI -S is a 1-item questionnaire where the response is recorded on a 4-point scale scored as: "normal" (1), "mild" (2), "moderate" (3), or "severe" (4).
Change from Baseline in Patient Global Impression of Change (PGI -C) Score
Time frame: Up to 5 years
PGI-C is a 7-point self-administered scale that assesses if there has been a change in the participant's health over time. Participants will rate their change as "1=very much improved," "2=much improved," "3=minimally improved," "4=no change," "5=minimally worse," "6=much worse," or "7=very much worse".
2 secondary outcomes
The Number of Participants With Adverse Events (AEs), Including Amyloid-Related Imaging Abnormality (ARIA), andSerious Adverse Events (SAEs) in Aducanumab-avwa-treated Participants in Real-world Per Label Recommendation
Time frame: Up to 5 years
To Obtain Descriptive Statistics on the Characteristics of the Aducanumab-avwa User Population and on Drug Utilization
Time frame: Up to 5 years
Results and safety
The study was stopped early (reason given: As a result of the national policy for coverage, it is expected there will be limited aducanumab-avwa prescription and usage in routine clinical practice making the study not feasible for enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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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
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimers Disease, run by Biogen at 22 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 4 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: stopped early, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 was stopped early (reason given: As a result of the national policy for coverage, it is expected there will be limited aducanumab-avwa prescription and usage in routine clinical practice making the study not feasible for enrollment.). Results are not available in the source record.
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?
Change from Baseline in Quick Dementia Rating Scale Informant Version & Patient Version (QDRS-IV/PV) Score (time frame: Up to 5 years). The study lists 12 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 18 Apr 2023.