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

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.

Study Overview

• Status: Recruiting
• Conditions: Mild Cognitive Impairment (MCI); Alzheimer Disease
• Intervention / Treatment: Drug: Lecanemab 10 mg/kg

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Yanxing Chen, M.D.; Phone Number: +86 188 6840 1257; Email: chenyanxing@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Affiliated Hospital, School of Medicine, Zhejiang University, China
      • Contact: Yanxing Chen, MD; Phone Number: +86 188 6840 1257; Email: chenyanxing@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study included early AD patients treated with Lecanemab at the Second Affiliated Hospital of Zhejiang University School of Medicine.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Drug: Lecanemab 10 mg/kg; Lecanemab was administered 10mg/kg every two weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CDR-SB Score	All study subjects underwent Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) assessment by a specialist before the 1st dose (V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39). CDR-SB, with total scores ranging from 0 to 18, can be used to measure cognitive changes in the early stages of Alzheimer's disease, with higher scores indicating more severe symptoms.	CDR-SB scales by baseline before the 1st dose(V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39)
MMSE	All study subjects underwent Mini Mental State Examination (MMSE) assessment by a specialist before the 1st dose (V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39). MMSE, with total scores ranging from 0 to 30, can be used to measure cognitive changes in the early stages of Alzheimer's disease, with lower scores indicating more severe symptoms.	MMSE scales by baseline before the 1st dose(V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39)
ADCs-ADL	All study subjects underwent Alzheimer's Disease Cooperative Study-Activity of Daily Life (ADCs-ADL) assessment by a specialist before the 1st dose (V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39). CDR-SB, with total scores ranging from 0 to 78, can be used to measure activity of daily life changes in the early stages of Alzheimer's disease, with lower scores indicating more severe symptoms.	ADCs-ADL scales by baseline before the 1st dose(V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39)
NPI	All study subjects underwent Neuropsychiatric Inventory (NPI) assessment by a specialist before the 1st dose (V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39). CDR-SB, with total scores ranging from 0 to 18, can be used to measure cognitive changes in the early stages of Alzheimer's disease, with higher scores indicating more severe symptoms.	NPI scales by baseline before the 1st dose(V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aβ-PET Burden	All study subjects underwent Aβ positron emission tomography (PET) before the 1st dose (V1) ,at 12 and 18 months after treatment (V26,V39). The investigators quantified participants' Aβ burden using the average cortical standard uptake value ratio (SUVR), that is, tracer uptake in medial orbital frontal, lateral temporal, parietal, anterior cingulate, posterior cingulate, and precuneus regions divided by uptake in the cerebellar reference region.	Aβ-PET tested by baseline before the 1st dose(V1) , at 12 and 18 months after treatment (V25,V39)
MRI	All study subjects underwent magnetic resonance imaging (MRI) before the 1st dose (V1) ,at 2, 3, 6,12 and 18 months after treatment. The scan includes T1, T2 fluid attenuated inversion recovery (FLAIR, 5 mm slice thickness), susceptibility weighted imaging (SWI, 1 mm slice thickness) and diffusion weighted imaging (DWI). The MRI scan can be used to meature the study subjects' hippocampus atrophy and white matter hyperintensities and to detect whether adverse events such as amyloid-related imaging abnormalities happen.	Time Frame: MRI tested by baseline before the 1st dose(V1) , at 2, 3, 6, 12 and 18 months after treatment (V5, V7, V14, V25, V39)
Biospecimen	All study subjects underwent blood collection before the 1st dose (V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39) for routine blood tests, liver and kidney function, plasma biomarkers, and other indicators. Among them, the APOE genotype of subjects will be tested before the 1st dose.	Blood tested by baseline before the 1st dose(V1) , at 3, 6,12 and 18 months after treatment(V7, V14, V25, V39)

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Director: Baorong Zhang, M.D., Zhejiang University School of Medicine Second Affiliated Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): December 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 3, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Alzheimer Disease; Cognition; Lecanemab; Amyloid-related imaging abnormalities
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Cognitive Dysfunction; Alzheimer Disease; lecanemab
• Other Study ID Numbers: 2024-1113; 82371190 (Other Grant/Funding Number: National Natural Science Foundation of China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes