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NCT07152418

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

Not yet recruiting Last updated 3 September 2025
What this trial tests

trial testing Lecanemab 10 mg/kg in Alzheimer Disease (AD) in 120 participants. Not yet recruiting.

Timeline
1 September 2025
Primary endpoint
1 September 2027
1 September 2028

Quick facts

Lead sponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
StatusNot yet recruiting
Study typeOBSERVATIONAL
Enrollment120
Start date1 September 2025
Primary completion1 September 2027
Estimated completion1 September 2028

Drugs / interventions tested

Conditions studied

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Who can join

Adults 50 to 85, any sex, with Alzheimer Disease (AD) or Alzheimer Dementia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Preliminary clinical trial results indicate that Aβ-targeting monoclonal antibody drugs can delay disease progression more effectively. However, some patients still progress slowly to the moderate stage during treatment despite maintaining low Aβ/tau pathological protein loads. For such cases, patients and their families are fully informed about the potential lack of efficacy with continued treatment, and the decision is left to their discretion. Information regarding whether treatment is continued is documented and followed up to determine whether sustained benefits can be achieved. Previous further studies on lecanemab suggest that patients with low or absent tau pathology derive more significant clinical benefits, though large-sample validation remains lacking. This project will therefore enroll patients at clinical stages 3-4 (0.5 ≤ CDR ≤ 1) and monitor those progressing to moderate AD (CDR = 2) during monoclonal antibody therapy. Using tau pathology stratification, the study aims to identify which AD patients are most suitable for monoclonal antibody treatment and evaluate whether therapy continuation yields sustained benefits in patients progressing to moderate dementia, as well as whether patient selection should integrate both pathological (a-c stage) and clinical diagnoses.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Lecanemab 10 mg/kg

Trials testing the same drug.

Other recruiting trials for Alzheimer Disease (AD)

Currently open trials in the same condition.

Other Second Affiliated Hospital, School of Medicine, Zhejiang University trials

Trials by the same sponsor.

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