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

NCT06741553 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2025-09-03

No results posted yet for this 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.

Conditions

  • Alzheimer Disease
  • Mild Cognitive Impairment (MCI)

Interventions

DRUG

Lecanemab 10 mg/kg

Lecanemab was administered 10mg/kg every two weeks.

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Baorong Zhang, M.D. · Zhejiang University School of Medicine Second Affiliated Hospital

Eligibility

Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-28
Primary Completion
2026-06-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06741553 on ClinicalTrials.gov