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

August 26, 2025 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • Affiliated Hospital, School of Medicine, Zhejiang University, China
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CDR-SB Score
Time Frame: CDR-SB scales by baseline before the 1st dose(V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39)
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
Time Frame: MMSE scales by baseline before the 1st dose(V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39)
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
Time Frame: ADCs-ADL scales by baseline before the 1st dose(V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39)
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
Time Frame: NPI scales by baseline before the 1st dose(V1) and at 3, 6, 12, and 18 months after treatment (V7, V14, V25, V39)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Aβ-PET Burden
Time Frame: Aβ-PET tested by baseline before the 1st dose(V1) , at 12 and 18 months after treatment (V25,V39)
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
Time Frame: 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)
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
Time Frame: Blood tested by baseline before the 1st dose(V1) , at 3, 6,12 and 18 months after treatment(V7, V14, V25, V39)
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Baorong Zhang, M.D., Zhejiang University School of Medicine Second Affiliated Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 28, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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