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Therapeutic Efficacy of Monoclonal Antibody Drugs for Alzheimer's Disease Based on PET Research

A Study on the Therapeutic Efficacy of Monoclonal Antibody Drugs for Alzheimer's Disease Based on PET Research

Asset

Lecanemab

Listed sites

0

Recruiting sites

-

Enrollment

120

estimated

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•mild-to-moderate AD•Amyloid biomarker required (PET)•MRI contraindications excluded

Primary endpoint

•Amyloid PET Centiloid

Identifiers

Registered as

Org study ID2025-0466
NCT IDNCT07152418

Timeline

Milestones

Study start2025-09-01estimated
Study first posted2025-09-03actual
Last update posted2025-09-03actual
Primary completion2027-09-01estimated
Study completion2028-09-01estimated

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 Mild Cognitive Impairment (MCI) due to Alzheimer's Disease or mild-to-moderate AD. [Clinical Scores: CDR Global Score = 0.5 (for MCI) or 1 (for mild AD), corresponding to clinical stages 3-4, with a positive PIB-PET scan confirming amyloid pathology]
•Male or Female
•Between 50 and 85 years old (inclusive)
•Not currently participating in any other clinical trial or research study
•Participants must provide informed consent for this trial prior to enrollment and must voluntarily sign a written informed consent form
•Participants must be able to communicate effectively with the investigator and are expected to comply with the study requirements to completion

Exclusion criteria

•Any contraindication to MRI
•History of seizure within the past 6 months or refractory epilepsy.
•Unstable or severe psychiatric illness within the past 6 months.
•History of bleeding disorders, coagulopathy, or clinically significant coagulation abnormalities (e.g., platelet count <50,000/μL or INR >1.5).
•Uncontrolled diabetes mellitus or hypertension.
•History of unstable angina, myocardial infarction, advanced heart failure, or clinically significant conduction abnormalities within the past year.
•Active cancer treatment (e.g., chemotherapy, biologics, or radiation therapy), except maintenance therapy for cancers in remission (e.g., anti-estrogen therapy for breast cancer).
•Immunological disorders requiring ongoing immunosuppression, immunoglobulin therapy, monoclonal antibodies, or plasmapheresis.
•Breastfeeding individuals or women of childbearing potential not using highly effective contraception.
•History of severe allergic, anaphylactic reactions, or hypersensitivity to any inactive ingredients.

Endpoints (6)

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
2
Amyloid biomarkers
2
Behavior / neuropsychiatric
1
Other (unclassified)
1

Global cognition

2 endpoints
Secondary/protocol endpoint

Change from Baseline in the MMSE at 18 Months

Time frame:Baseline, 18 months

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in the MoCA at 18 Months

Time frame:Baseline, 18 months

Montreal Cognitive Assessment (MoCA)

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Change from Baseline in the NPI at 18 Months

Time frame:Baseline, 18 months

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Amyloid biomarkers

2 endpoints
Primary/protocol endpoint

Aβ-PET centiloid values

Time frame:Baseline, 18 months

Amyloid PET Centiloid

descriptive

Secondary/protocol endpoint

Blood AD molecular pathology

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

Phosphorylated tau 217 (p-tau217)

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Change from Baseline in the CDR at 18 Months

Time frame:Baseline, 18 months

change from baseline, improvement

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.