Actively Recruiting
Prospective Cohort Study of Patients With Early Alzheimer's Disease Treated With Lecanemab
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-09-03
120
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
As the population increases and aging intensifies, cognitive disorders represented by Alzheimer's disease (AD) not only pose a severe threat to public health but also bring significant social and economic burdens. Previously, treatment options for Alzheimer's disease were very limited, mainly providing symptomatic relief with few available medications. Lecanemab, an FDA-approved clinical treatment drug in 2023, targets the core pathology of AD-abnormal amyloid-beta (Aβ) aggregation in the brain-and has been validated through both biomarker and clinical scale assessments. The optimal dosage and safety-efficacy profile of lecanemab for treating early AD have been observed in phase 2 and phase 3 clinical trials. However, the use of lecanemab may lead to certain adverse effects, including infusion-related reactions, amyloid-related imaging abnormalities (ARIA), such as microhemorrhages or hemosiderin deposits (ARIA-H), and ARIA-E. This study aims to establish a prospective follow-up cohort of patients treated with lecanemab to observe changes in cranial imaging characteristics and clinical symptoms, assess the cognitive improvement effects of lecanemab in early AD patients (stages 3-4), and monitor the risk factors for adverse event occurrence.
CONDITIONS
Official Title
Prospective Cohort Study of Patients With Early Alzheimer's Disease Treated With Lecanemab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mini-Mental State Examination (MMSE) score between 22 and 30
- Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score between 0.5 and 1
- Confirmation of positive amyloid pathology by Amyloid-PET or cerebrospinal fluid Ab2 testing
- Completion of APOE gene testing
- Willingness to use Lecanemab
You will not qualify if you...
- Unable to tolerate MRI scans
- MRI showing hemorrhagic manifestations such as more than 4 microbleeds, surface iron deposits, prior major hemorrhage, or brain lesions or vascular malformations
- Use of anticoagulants or antiplatelet drugs, hemorrhagic diseases, or any conditions increasing risk of central nervous system bleeding
- Unstable physical conditions or mental disorders
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
Y
Yanxing Chen, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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