← Trials/Trial dossier/NCT07544953

Not yet recruitingPhase NA

Amyloid Monoclonal Antibody Treatment in PD Patients With Coexistent AD Pathology

Efficacy of Lecanemab in Patients With Parkinson's Disease With Coexistent Alzheimer's Disease

Lead sponsor

Yonsei University

Asset

Lecanemab

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•Amyloid biomarker required (PET)

Primary endpoint

•Changes in amyloid dposition on amyloid imaging scans

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 ID4-2025-1358

NCT IDNCT07544953

Timeline

Milestones

Study first posted2026-04-22actual

Last update posted2026-04-22actual

Study start2026-05estimated (month precision)

Primary completion2030-06estimated (month precision)

Study completion2030-11estimated (month precision)

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. Patients diagnosed with Parkinson's disease

2. Amyloid deposition confirmed by FBB PET

3. Mild cognitive impairment or early dementia (CDR 0.5 or 1) on neuropsychological tests

4. Adults aged 50-90 years

Exclusion criteria

1. Cases in which lecanemab administration is contraindicated (based on recommendations from the Korean Dementia Association)

2. Cases in which neuropathologies other than Parkinson's disease or Alzheimer's disease are suspected as the underlying disease

Endpoints (8)

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

Other (unclassified)

Amyloid biomarkers

Fluid / digital biomarkers

Global cognition

3 endpoints

Secondary/protocol endpoint

longitudinal changes in the MMSE score

Time frame:Change from baseline to 18 months

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

longitudinal changes in the MoCA score.

Time frame:Change from baseline to 18 months

Montreal Cognitive Assessment (MoCA)

change from baseline, improvement

Secondary/protocol endpoint

longitudinal changes in CDR-SB.

Time frame:Change from baseline to 18 months

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

change from baseline, improvement

Amyloid biomarkers

1 endpoint

Primary/protocol endpoint

Changes in amyloid dposition on amyloid imaging scans

Time frame:Change from baseline to 18 months

ratio, descriptive

Fluid / digital biomarkers

1 endpoint

Secondary/protocol endpoint

Longitudinal changes in the plasma and cerebrospinal fluid biomarkers

Time frame:Change from baseline to 18 months

ratio, descriptive

Other (unclassified)

3 endpoints

Secondary/protocol endpoint/low confidence

longituidnal changes in UPDRS-III scores.

Time frame:Change from baseline to 18 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

longituidnal changes in composite scores of each cognitive domain.

Time frame:Change from baseline to 18 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

longituidnal changes in levodopa-equivalent doses per body weight [mg/kg].

Time frame:Change from baseline to 18 months

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.