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Recruiting

Prospective Cohort Study of Patients With Early Alzheimer's Disease Treated With Lecanemab

A Study That Uses an Organized System to Prospectively Collect Uniform Data From a Defined Population

Asset

Lecanemab

Listed sites

1

Recruiting sites

1

Enrollment

120

estimated

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•Amyloid biomarker required (PET/CSF)•CDR-SB 0.5-1•MMSE 22-30

Primary endpoints

•Clinical Dementia Rating-Sum of Boxes (CDR-SB)•Mini-Mental State Examination (MMSE)

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 ID2024-1113
Other grant82371190National Natural Science Foundation of China
NCT IDNCT06741553

Timeline

Milestones

Study start2024-06-28actual
Study first posted2024-12-19actual
Last update posted2025-09-03actual
Primary completion2026-06estimated (month precision)
Study completion2027-06estimated (month precision)

Assets

Drug assets

Lecanemab

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Maximum age85 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Mini-Mental State Examination (MMSE) score between 22 and 30, Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score between 0.5 and 1;
•Confirmation of positive amyloid pathology by Amyloid-PET or cerebrospinal fluid Aβ testing;
•Completion of APOE gene testing.
•Willingness to use Lecanemab

Exclusion criteria

•Unable to tolerate MRI scans;
•MRI showing hemorrhagic manifestations, including >4 microbleeds, surface iron deposition in any region, previous major hemorrhage, or potential brain lesions or vascular malformations;
•Use of anticoagulants or antiplatelet drugs, presence of hemorrhagic diseases, or any other conditions that increase the risk of central nervous system bleeding;
•With unstable physical conditions, unstable mental disorders, or those who are pregnant or breastfeeding.

Endpoints (7)

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.

Coverage by outcome category

Global cognition
4
Amyloid biomarkers
1
Neuroimaging
1
Other (unclassified)
1

Global cognition

4 endpoints
Primary/protocol endpoint

CDR-SB Score

Time frame:CDR-SB scales by baseline before the 1st dose(V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39)

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

categorical status, descriptive

Primary/protocol endpoint

MMSE

Time frame:MMSE scales by baseline before the 1st dose(V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39)

Mini-Mental State Examination (MMSE)

categorical status, descriptive

Primary/protocol endpoint

ADCs-ADL

Time frame:ADCs-ADL scales by baseline before the 1st dose(V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39)

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

categorical status, descriptive

Primary/protocol endpoint

NPI

Time frame:NPI scales by baseline before the 1st dose(V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39)

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

categorical status, descriptive

Amyloid biomarkers

1 endpoint
Secondary/protocol endpoint

MRI

Time frame:Time Frame: MRI tested by baseline before the 1st dose(V1) , at 2, 3, 6, 12 and 18 months after treatment (V5, V7, V14, V25, V39)

event count, event

Neuroimaging

1 endpoint
Secondary/protocol endpoint

Aβ-PET Burden

Time frame:Aβ-PET tested by baseline before the 1st dose(V1) , at 12 and 18 months after treatment (V25,V39)

ratio, descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Biospecimen

Time frame:Blood tested by baseline before the 1st dose(V1) , at 3, 6,12 and 18 months after treatment(V7, V14, V25, V39)

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.