Skip to main content
Delfa

← Trials/Trial dossier/NCT05925621

Recruiting

Cognitive Neurology Unit Clinical Registry

Cognitive Neurology Unit's Anti-amyloid Monoclonal Antibodies for the Treatment of Alzheimer's Disease Clinical Registry

Asset

Lecanemab

Listed sites

1

Recruiting sites

1

Enrollment

500

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Amyloid biomarker required (PET)

Primary endpoints

•Whether Anti-Amyloid Mabs Slow Cognitive And Functional Decline•To Identify Any Associations Between Side Effects And Patient Characteristics•Time Course Of Clinical Benefits

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID2023P000494
NCT IDNCT05925621

Timeline

Milestones

Study first posted2023-06-29actual
Study start2023-07-16actual
Last update posted2026-04-13actual
Primary completion2028-06estimated (month precision)
Study completion2028-06estimated (month precision)

Assets

Drug assets

Lecanemab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age95 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•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 criteria

•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

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Amyloid biomarkers

3 endpoints
Primary/protocol endpoint

To Determine Whether Anti-Amyloid Mabs Slow Cognitive And Functional Decline

Time frame:30 months

descriptive

Primary/protocol endpoint

To Identify Any Associations Between Side Effects And Patient Characteristics

Time frame:30 months

descriptive

Primary/protocol endpoint

To Establish The Time Course Of Clinical Benefits

Time frame:30 months

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.