An Observational Study on Lecanemab Treatment for Early Alzheimer's Disease

Recruiting

• Conditions: Alzheimer Disease

• Registration Number: NCT07153848
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

Brief Summary

The goal of this observational study is to valuate the sensitivity and specificity of different blood biomarkers for monitoring and assessing Aβ-PET-confirmed mitigation of amyloid pathology by lencanumab treatment in subjects treated with lencanumab.

Detailed Description

This study was a prospective observational study of a patient population treated or planning to be treated with lencanemab from a multicenter cohort of patients with early-stage AD in Zhejiang Province. It was a real-world study based on the treatment of lencanemab. The primary enrollment population was patients with mild AD or mild AD-origin cognitive disorders who had completed positive Aβ-PET scans that met the PET quality-control criteria and who were receiving treatment with lencanemab. Patients with cognitive impairment were divided into two subgroups: those receiving donepezil treatment alone and those receiving lencanemab combined with standard treatment with donepezil. Fresh plasma was collected at baseline, 3 months of follow-up, 6 months of follow-up, 12 months of follow-up, and 18 months of follow-up, respectively. Amyloid PET scanning was performed at 12 months of follow-up and 18 months of follow-up. In order to evaluate the sensitivity and specificity of different blood biomarkers for monitoring and assessing the alleviation of amyloid pathology progression by Aβ-PET-confirmed lencanumab treatment, blinded peripheral blood AD core marker assays were performed in the main central laboratory. Furthermore, the aim was to provide a follow-up tool suitable for clinical blood marker-based monitoring of lencanumab treatment.

Study Timeline

• Study Start: 2024-07-01
• Status Verified: 2024-11
• Study First Submitted: 2025-05-07
• Primary Completion: 2025-07-01
• Study First Submitted QC: 2025-08-31
• Last Update Submitted: 2025-08-31
• Study First Posted: 2025-09-04
• Last Update Posted: 2025-09-04
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with blood biomarkers	Fresh plasma was collected at baseline, 3 months of follow-up, 6 months of follow-up, 12 months of follow-up, and 18 months of follow-up, respectively	Blinded peripheral blood AD core marker testing including but not limited to Aβ40, Aβ42, total tau, p-tau181/217, NFL, GFAP

Secondary Outcome Measures

Name	Time	Method
Aβ-PET	Amyloid PET scan at 12 months follow-up, 18 months follow-up	Aβ-PET scanning was conducted on enrolled patients to evaluate alterations in the quantity of amyloid plaque deposits within their brains.
Cognitive funtion - MMSE	was collected at baseline, 3 months of follow-up, 6 months of follow-up, 12 months of follow-up, and 18 months of follow-up, respectively	Multidimensional neuropsychological assessment is mainly used to assess the cognitive function of patients. MMSE is widely used in cognitive dysfunction which consists of the following ten parts: orientation, memory, attention and numeracy, ability to recall, language skills, including naming ability, retelling ability, three-step command, reading ability, writing ability. The values range from 0 to 30, with higher score indicating better outcome.
Cognitive funtion - MoCA	was collected at baseline, 3 months of follow-up, 6 months of follow-up, 12 months of follow-up, and 18 months of follow-up, respectively	Multidimensional neuropsychological assessment is mainly used to assess the cognitive function of patients. MoCA is also an assessment tool for rapid screening of cognitive dysfunction, including 8 cognitive domains such as visual structure skills, executive function, memory, language, attention and concentration, calculation, abstract thinking and orientation. The values range from 0 to 30, with higher score indicating better outcome.

Trial Locations

Locations (1)

The First Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China