Cognitive Neurology Unit Clinical Registry
Cognitive Neurology Unit's Anti-amyloid Monoclonal Antibodies for the Treatment of Alzheimer's Disease Clinical Registry
1 other identifier
observational
500
1 country
1
Brief Summary
A Prospective Comparative Study Of Monoclonal Antibodies For The Treatment Of Alzheimer's Disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2023
CompletedFirst Posted
Study publicly available on registry
June 29, 2023
CompletedStudy Start
First participant enrolled
July 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
April 13, 2026
April 1, 2026
4.9 years
June 22, 2023
April 8, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
To Determine Whether Anti-Amyloid Mabs Slow Cognitive And Functional Decline
This study is a prospective, registry-based, single unit, observational study comparing clinical outcome in patients receiving anti-amyloid mAb therapy to historical norms.
30 months
To Identify Any Associations Between Side Effects And Patient Characteristics
This study is a prospective, registry-based, single unit, observational study comparing anti-amyloid mAb therapy patient demographics to clinical outcomes.
30 months
To Establish The Time Course Of Clinical Benefits
This study is a prospective, registry-based, single unit, observational study examining anti-amyloid mAb therapy patient clinical outcomes and adverse effects over time.
30 months
Study Arms (1)
Lecanemab
Patients with Alzheimer Disease receiving anti-amyloid mAb therapy at the BIDMC
Interventions
Eligibility Criteria
We will enroll patients under the care of the CNU. All patients with a concern for cognitive impairment secondary to AD interested in receiving anti-amyloid monoclonal antibody therapy will be enrolled into this registry as required by CMS. * Patients with a diagnosis of AD based on National Institute on Aging and the Alzheimer's Association diagnostic guidelines. * Patients with a diagnosis of MCI based on the National Institute on Aging and the Alzheimer's Association and Petersen criteria. * All patients eligible to receive anti-amyloid therapy will have confirmation of AD through a positive amyloid PET.
You may qualify if:
- o Patient meets clinical criteria for mild cognitive impairment or early dementia from Alzheimer's disease
- Patient has evidence of cognitive impairment on neuropsychological testing
- Patient has not progressed to the moderate stage of dementia based on neuropsychological testing or clinical judgement
- Amyloid PET imaging and/or CSF analysis consistent with Alzheimer's disease
- Amyloid PET imaging positive
- CSF p-Tau/Abeta42 ration \>0.023 and ABeta42 \< 1027\*\*
- T MRI in past 6 months
- Patient has a care partner
- Patient under the care of an appropriate BI-Lahey amyloid clinic
- Patient is on a stable medication regimen
You may not qualify if:
- o Recent stroke or suspected TIA in the past year
- Pregnancy
- Active autoimmune or immunological disease
- Systemic treatment with immunosuppressants, immunoglobulins, or monoclonal antibodies or their derivatives
- Bleeding disorder with Plts \< 50,000 or INR \> 1.5
- On warfarin, heparin, or DOAC
- On dual antiplatelet therapy
- Non Alzheimer disease cause of dementia/MCI
- ApoE e4 homozygote
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 30 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Cognitive Neurology Unit
Study Record Dates
First Submitted
June 22, 2023
First Posted
June 29, 2023
Study Start
July 16, 2023
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
Data sets may be shared with members outside the study team following de-identification under approved data use agreements (DUAs) as needed. Within the REDcap database, access to the identifiable information will be limited to study staff members and to staff managing the database. Any data that may require a physical transfer from one place to another will be done using removable encrypted data storage devices.