NCT07153848 An Observational Study on Lecanemab Treatment for Early Alzheimer's Disease
| NCT ID | NCT07153848 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital of Zhejiang University |
| Condition | Alzheimer Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2025-07-01 |
Trial Parameters
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Brief Summary
The goal of this observational study is to valuate the sensitivity and specificity of different blood biomarkers for monitoring and assessing Aβ-PET-confirmed mitigation of amyloid pathology by lencanumab treatment in subjects treated with lencanumab.
Eligibility Criteria
Inclusion criteria (all of the following must be met simultaneously): Mild Alzheimer's Disease (AD): 1. Age ≥ 45 years but ≤ 85 years; 2. Literacy level of elementary school and above (i.e., ≥3 years of education); 3. Fulfillment of the diagnostic criteria for probable AD in the NINCDS-ADRDA 2007 revision (or the diagnostic criteria for clinically probable AD in the National Institute on Aging and Alzheimer's Disease Association NIA-AA 2011 edition); 4. Clinical Dementia Rating Scale CDR-global = 1 point; 5. Aβ-PET scan suggesting extensive deposition of Aβ plaques in the brain. AD-derived mild cognitive impairment (aMCI) inclusion criteria (must meet all of the following conditions at the same time): 1. Age: 45 years or older but ≤85 years; 2. Literacy level elementary school and above (i.e., ≥3 years of education); 3. Meeting Peterson's 2004 diagnostic criteria for MCI: (i) Complaint of memory impairment that can be confirmed by an informed person; (ii) objective evidence of memory i
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