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NCT07152418
Therapeutic Efficacy of Monoclonal Antibody Drugs for Alzheimer's Disease Based on PET Research
trial testing Lecanemab 10 mg/kg in Alzheimer Disease (AD) in 120 participants. Not yet recruiting.
1 September 2027
Quick facts
| Lead sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 120 |
| Start date | 1 September 2025 |
| Primary completion | 1 September 2027 |
| Estimated completion | 1 September 2028 |
Drugs / interventions tested
- Lecanemab 10 mg/kg — full drug profile →
- Conventional anti-dementia treatment group — full drug profile →
Conditions studied
- Alzheimer Disease (AD) — all drugs for Alzheimer Disease (AD) →
- Alzheimer Dementia — all drugs for Alzheimer Dementia →
- Mild Cognitive Impairment (MCI) — all drugs for Mild Cognitive Impairment (MCI) →
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.
Verify or expand the search:
- PubMed search for NCT07152418
- Europe PMC full search
- ASCO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07152418 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Second Affiliated Hospital, School of Medicine, Zhejiang University
- Last refreshed: 3 September 2025
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