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Not yet recruiting

Efficacy of Lecanemab at Different Therapeutic Doses for Alzheimer's Disease (AD) in Real-World Practice

Asset

Lecanemab

Listed sites

1

Recruiting sites

-

Enrollment

140

estimated

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Amyloid PET Centiloid

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 ID2025-1393
NCT IDNCT07505095

Timeline

Milestones

Study first posted2026-04-01actual
Last update posted2026-04-01actual
Study start2026-04-30estimated
Primary completion2027-04-30estimated
Study completion2028-01-31estimated

Assets

Drug assets

Lecanemab

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Meet the diagnostic criteria for AD-derived MCI or early AD [Clinical rating: CDR 0.5 (MCI) / 1.0 (mild AD), i.e., clinical stage 3-5; PIB-PET positive for pathology]
•Male or female
•50-85 years old
•Not currently participating in other research studies
•Volunteers must provide written informed consent prior to study participation and voluntarily sign the informed consent form
•Volunteers are able to communicate effectively with investigators and comply with study procedures to complete the study

Exclusion criteria

•Other neurological disorders: e.g., vascular dementia, dementia with Lewy bodies, frontotemporal lobar degeneration, prion diseases, etc.
•Systemic diseases or metabolic disorders: e.g., hypothyroidism, vitamin B12 deficiency, hepatic and renal failure.
•Infectious diseases: e.g., neurosyphilis, HIV-associated encephalopathy, and other infectious diseases.
•Psychiatric disorders: cognitive symptoms caused by severe depression (pseudodementia), schizophrenia, etc.
•Effects of drugs/toxins: long-term use of benzodiazepines, anticholinergic drugs, or alcohol dependence.

Endpoints (5)

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
3
Behavior / neuropsychiatric
1
Amyloid biomarkers
1

Global cognition

3 endpoints
Secondary/protocol endpoint

Change from Baseline in the Clinical Dementia Rating (CDR) at 18 Months

Time frame:Baseline, 6 months, 12 months, 18 months

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in the Mini-Mental State Examination (MMSE) at 18 Months

Time frame:Baseline, 6 months, 12 months, 18 months

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in the Montreal Cognitive Assessment (MoCA) at 18 Months

Time frame:Baseline, 6 months, 12 months, 18 months

Montreal Cognitive Assessment (MoCA)

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Change from Baseline in the Neuropsychiatric Inventory (NPI) at 18 Months

Time frame:Baseline, 6 months, 12 months, 18 months

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Amyloid biomarkers

1 endpoint
Primary/protocol endpoint

Aβ-PET centiloid values

Time frame:Baseline, 18 months

Amyloid PET Centiloid

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.