RecruitingNCT06741553

Prospective Cohort Study of Patients With Early Alzheimer's Disease Treated With Lecanemab

A Study That Uses an Organized System to Prospectively Collect Uniform Data From a Defined Population


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

120 participants

Start Date

Jun 28, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Max Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study follows patients with early Alzheimer's disease who are receiving lecanemab, a recently approved drug that targets amyloid plaques in the brain — one of the hallmarks of Alzheimer's. It collects real-world data on how patients respond to the treatment and tracks safety over time. **You may be eligible if...** - You have early Alzheimer's disease with mild cognitive impairment or mild dementia (confirmed by standard scoring tests) - Your amyloid levels have been confirmed as elevated by a PET scan or cerebrospinal fluid test - You have completed genetic testing (APOE gene) - You are willing to take lecanemab **You may NOT be eligible if...** - You cannot tolerate MRI scans - Your MRI shows more than 4 microbleeds, iron deposits, or significant vascular brain lesions - You are taking blood-thinning medications (anticoagulants) or antiplatelet drugs - You have other serious medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLecanemab 10 mg/kg

Lecanemab was administered 10mg/kg every two weeks.


Locations(1)

Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

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NCT06741553


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