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Observational Study of Lecanemab for Alzheimer's Disease

This observational study is looking at how Lecanemab, a monoclonal antibody (a type of protein that helps the body fight off disease), affects people with Alzheimer's disease. Researchers want to see if Lecanemab can slow down the decline in thinking and daily function. They will also look for any links between side effects and patient characteristics, and how long it takes to see benefits. You might be able to join if you are between 50 and 95 years old and have mild cognitive impairment (early memory or thinking problems) or early Alzheimer's disease. You would also need to show cognitive impairment on tests and have evidence of amyloid in your brain through PET scans or spinal fluid analysis. The study aims to enroll 500 participants, but its current status is unclear.

Study design
This is an observational study, meaning researchers will watch how Lecanemab affects participants over time. It plans to include 500 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure outcomes at 30 months to understand the time course of clinical benefits and associations between side effects and patient characteristics.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05925621

Cognitive Neurology Unit Clinical Registry

Recruiting
Not specifiedAges 50–95Observational
Beth Israel Deaconess Medical Center
~500 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:Lecanemab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To Determine Whether Anti-Amyloid Mabs Slow Cognitive And Functional Decline
Measured over 30 months
+2 more outcomes measured

Conditions

Alzheimer Disease

Explore related trials

Alzheimer's DiseaseAbeta42Amyloidp-Tau/Abeta42

Where it's being run

1 sites across 1 states
Massachusetts1

Who to contact

Dan Z Press, MD
[email protected]
(617) 667-4074
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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\*\*
3T 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

Exclusion

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

What this trial measures

  • To Determine Whether Anti-Amyloid Mabs Slow Cognitive And Functional Decline30 months

    This study is a prospective, registry-based, single unit, observational study comparing clinical outcome in patients receiving anti-amyloid mAb therapy to historical norms.

  • To Identify Any Associations Between Side Effects And Patient Characteristics30 months

    This study is a prospective, registry-based, single unit, observational study comparing anti-amyloid mAb therapy patient demographics to clinical outcomes.

  • To Establish The Time Course Of Clinical Benefits30 months

    This study is a prospective, registry-based, single unit, observational study examining anti-amyloid mAb therapy patient clinical outcomes and adverse effects over time.