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NCT07544953Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 22 Apr 2026

Brief summary (registry, in English)

This study aimed to determine the efficacy of amyloid clearance of lecanemab in patients with Parkinson's disease (PD) with amyloid co-pathology. Lecanemab, an anti-amyloid monoclonal antibody, was apporoved by the US FDA in July 2023 and in South Korea in May 2024, as a disease-modifying therapy based on its clinical efficacy and reduction of amyloid plaques in patients with early-stage Alzheimer's disease (AD). AD pathology is also common in PD, and approximately 35% of patients with PD dementia have co-existing AD pathology. Currently, no mediations have been developed to slow the progression of PD. Therefore, this study aimed to determine whether reducing the amyloid burden in patients with PD with co-exsistent AD pathology could potentially slow disease progression. To test it, patients with PD with mild cognitive impairment or early dementia, who were confirmed to have amyloid deposition through amyloid imaging, would be enrolled as a treatment arm, and the degree of reduction of amyloid plaque after 18 months of lecanemab administration would be investigated.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
21 Dec 2025
Start date
1 May 2026
Primary completion date
30 Jun 2030
Lead sponsor
Yonsei University
NCT number
NCT07544953

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 1 May 2026 to the primary completion date, 30 Jun 2030
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Cases in which lecanemab administration is contraindicated (based on recommendations from the Korean Dementia Association)
  • Cases in which neuropathologies other than Parkinson's disease or Alzheimer's disease are suspected as the underlying disease

Who the study is looking for

  • Patients diagnosed with Parkinson's disease
  • Amyloid deposition confirmed by FBB PET
  • Mild cognitive impairment or early dementia (CDR 0.5 or 1) on neuropsychological tests
  • Adults aged 50-90 years

Age in the registry: 50 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Yonsei University College of Medicine
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.