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

NCT ID: NCT06741553

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-28
• Study Completion Date: 2027-06-30

Brief 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)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Treated Group

This is an observational study. The investigators included early AD patients treated with Lecanemab, and evaluated them by plasma, magnetic resonance imaging (MRI) examination and clinical scale. The investigators observed the changes in MRI characteristics and clinical symptoms of patients after Lecanemab administration, evaluated the improvement effect of Lecanemab on cognitive function, and monitored the risk factors of adverse reactions.

Lecanemab 10 mg/kg

Intervention Type: DRUG

Lecanemab was administered 10mg/kg every two weeks.

Interventions

Lecanemab 10 mg/kg

Lecanemab was administered 10mg/kg every two weeks.

Intervention Type: DRUG

Eligibility Criteria

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.

• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Baorong Zhang, M.D.

Role: STUDY_DIRECTOR

Zhejiang University School of Medicine Second Affiliated Hospital

Locations

Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yanxing Chen, M.D.

Role: CONTACT

chenyanxing@zju.edu.cn

+86 188 6840 1257

Facility Contacts

Yanxing Chen, MD

Role: primary

chenyanxing@zju.edu.cn

+86 188 6840 1257

Other Identifiers

82371190

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024-1113

Identifier Type: -

Identifier Source: org_study_id