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RecruitingPhase 4

Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs

Multicenter, Randomized, Controlled Study Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs

Asset

Lecanemab

Listed sites

1

Recruiting sites

1

Enrollment

200

estimated

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•Amyloid biomarker required (PET/CSF)•MMSE ≥20•Study partner/caregiver required•MRI contraindications excluded•History of intracranial hemorrhage excluded

Primary endpoint

•Amyloid PET Centiloid

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 IDKY2025-355
NCT IDNCT07604896

Timeline

Milestones

Study start2026-01-01actual
Study first posted2026-05-22actual
Last update posted2026-05-22actual
Primary completion2027-12-31estimated
Study completion2028-12-31estimated

Assets

Drug assets

Lecanemab

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Age: 50 to 90 years old.
•No gender restrictions.
•Patients with MCI and mild AD.
•The MMSE score is ≥20, and the overall CDR score is 0.5 or 1 point.
•Positive Amyloid protein confirmed by amyloid-PET or CSF.
•There is a reliable caregiver accompanying the patient during the research visit and supervising the use of the study drug during the trial.
•Agree to participate in the research and sign the informed consent form

Exclusion criteria

•Patients with cognitive impairment caused by reasons other than AD.
•There was a history of transient ischemic attack (TIA), stroke, cerebral hemorrhage or epileptic seizure within 12 months prior to screening.
•A Hamilton Depression Scale score of more than 17 at the time of screening, or any suicidal behavior within 6 months before screening, during screening, or at baseline visits, as well as other psychiatric diagnoses or symptoms (such as hallucinations, anxiety disorders, or delusions) that interfere with the research process of the subjects.
•Patients with hemorrhagic diseases or those receiving anticoagulant therapy, as well as any patients with malignant tumors, severe gastrointestinal, kidney, liver, respiratory, immune, endocrine and cardiovascular system diseases that affect this study.
•There is a hypersensitivity reaction to lecanemumab or any other component in the injection solution or any monoclonal antibody treatment.
•There are contraindications for MRI scans, including the installation of cardiac pacemakers/defibrillators and ferromagnetic metal implants (except for cranial and cardiac devices approved for safe use in MRI scans).
•There is a known or suspected history of drug or alcohol abuse or dependence within two years prior to screening.
•Subjects who participated in clinical studies involving any therapeutic monoclonal antibodies or novel compounds for the treatment of AD within 6 months prior to screening, unless it can be demonstrated that the subjects were in the placebo treatment group.
•Surgical operations under general anesthesia are planned to be performed during the research period.
•Women who have positive pregnancy test results, are breastfeeding or pregnant at the time of screening or baseline.

Endpoints (7)

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
2
Neuroimaging
2
Other (unclassified)
2
Amyloid biomarkers
1

Global cognition

2 endpoints
Secondary/protocol endpoint

Change of MoCA score

Time frame:baseline, 6 month, 12 month, 18 months

Montreal Cognitive Assessment (MoCA)

descriptive

Secondary/protocol endpoint

Change of MMSE score

Time frame:baseline, 6 month, 12 month, 18 months

Mini-Mental State Examination (MMSE)

descriptive

Amyloid biomarkers

1 endpoint
Primary/protocol endpoint

Change in Aβ-PET centiloid values

Time frame:baseline, 12 month, 18 months

Amyloid PET Centiloid

change from baseline, improvement

Neuroimaging

2 endpoints
Secondary/protocol endpoint

Change of structural MRI

Time frame:baseline, 6 month, 12 month, 18 month

descriptive

Secondary/protocol endpoint

Change of functional MRI

Time frame:baseline, 6 month, 12 month, 18 month

descriptive

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Change of retinal and cerbral imaging

Time frame:baseline, 6 month, 12 month

descriptive

Secondary/protocol endpoint/low confidence

Change of CDR score

Time frame:baseline, 6 month, 12 month, 18 months

descriptive

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.