ECL-Lecanemab

RecruitingPhase 4

Evaluation System for Lecanemab Efficacy Using Gold Electrode ECL to Monitor Alzheimer's Biomarkers

Construction of a Lecanemab Therapeutic Efficacy Evaluation System Based on Mesoporous Gold Electrode Surface-enhanced Electrochemiluminescence for Monitoring Dynamic Changes of Alzheimer's Disease Plasma Biomarkers

Lead sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Asset

Lecanemab

Listed sites

Recruiting sites

Enrollment

100

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•mild AD dementia•Amyloid biomarker required (PET/CSF)•CDR global 0.5•MMSE 22-30•Brain MRI excludes superficial siderosis

Primary endpoint

•Phosphorylated tau 181 (p-tau181)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDKY-2026-002

NCT IDNCT07688460

Timeline

Milestones

Study first posted2026-07-07actual

Last update posted2026-07-07actual

Study start2026-07-10estimated

Primary completion2029-03-30estimated

Study completion2029-03-30estimated

Assets

Drug assets

Lecanemab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

1. Diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease or mild Alzheimer's dementia.

2. Age between 50 and 90 years (inclusive).

3. Confirmed presence of amyloid pathology (positive amyloid PET scan or CSF biomarkers).

4. Mini-Mental State Examination (MMSE) score between 22 and 30.

5. Clinical Dementia Rating (CDR) global score of 0.5 or 1.

6. Stable dose of allowed concomitant medications for at least 4 weeks prior to screening.

7. Willing and able to comply with the study procedures, including blood draws for ECL monitoring.

8. Signed informed consent form

Exclusion criteria

1. Significant neurological disorders other than Alzheimer's disease (e.g., stroke, Parkinson's disease).

2. History of brain hemorrhage, microbleeds, or superficial siderosis on MRI.

3. Use of anticoagulants that cannot be safely interrupted.

4. Severe systemic diseases (e.g., severe heart failure, uncontrolled diabetes) that may interfere with the study.

5. Known hypersensitivity to Lecanemab or any excipients.

6. Pregnant or breastfeeding women.

7. Participation in another interventional clinical trial within the last 30 days.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Amyloid biomarkers

Global cognition

1 endpoint

Secondary/protocol endpoint

Change in CDR-SB Score

Time frame:Baseline, Month 6, Month 12, and Month 18

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Amyloid biomarkers

1 endpoint

Primary/protocol endpoint

Change in Plasma Alzheimer's Biomarkers

Time frame:Baseline and every 4 weeks during the 18-month treatment period

Phosphorylated tau 181 (p-tau181)

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.