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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Aβ testing; - Completion of APOE gene testing. - Willingness to use Lecanemab. Who Should NOT Join This Trial: - Unable to tolerate MRI scans; - MRI showing hemorrhagic manifestations, including \>4 microbleeds, surface iron deposition in any region, previous major hemorrhage, or potential brain lesions or vascular malformations; - Use of anticoagulants or antiplatelet drugs, presence of hemorrhagic diseases, or any other conditions that increase the risk of central nervous system bleeding; - With unstable physical conditions, unstable mental disorders, or those who are pregnant or breastfeeding. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Aβ testing; * Completion of APOE gene testing. * Willingness to use Lecanemab. Exclusion Criteria: * Unable to tolerate MRI scans; * MRI showing hemorrhagic manifestations, including \>4 microbleeds, surface iron deposition in any region, previous major hemorrhage, or potential brain lesions or vascular malformations; * Use of anticoagulants or antiplatelet drugs, presence of hemorrhagic diseases, or any other conditions that increase the risk of central nervous system bleeding; * With unstable physical conditions, unstable mental disorders, or those who are pregnant or breastfeeding.

Treatments Being Tested

DRUG

Lecanemab 10 mg/kg

Lecanemab was administered 10mg/kg every two weeks.

Locations (1)

Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, China