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

Phase

N/A

Condition

Dementia

Memory Loss

Mild Cognitive Impairment

Treatment

Lecanemab 10 mg/kg

Clinical Study ID

NCT06741553

2024-1113

82371190

Ages < 85
All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

Mini-Mental State Examination (MMSE) score between 22 and 30, Clinical DementiaRating Scale Sum of Boxes (CDR-SB) score between 0.5 and 1;
Confirmation of positive amyloid pathology by Amyloid-PET or cerebrospinal fluid Aβtesting;
Completion of APOE gene testing.
Willingness to use Lecanemab.

Exclusion

Exclusion Criteria:

Unable to tolerate MRI scans;
MRI showing hemorrhagic manifestations, including >4 microbleeds, surface irondeposition in any region, previous major hemorrhage, or potential brain lesions orvascular malformations;
Use of anticoagulants or antiplatelet drugs, presence of hemorrhagic diseases, orany other conditions that increase the risk of central nervous system bleeding;
With unstable physical conditions, unstable mental disorders, or those who arepregnant or breastfeeding.

Study Design