Amyloid Monoclonal Antibody Treatment in PD Patients With Coexistent AD Pathology

Sponsor
Yonsei University
Study ID
NCT07544953
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Lecanemab — DRUG
    Patients assigned to this arm receive lecanemab 10mg/kg intravenously every two weeks for 18 months.
  • Lecanemab non-administration group — OTHER
    Patients assigned to this arm do not receive lecanemab 10mg/kg intravenously during the follow-up period

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2030
Completion
Nov 30, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lecanemab admnistration group
    Patients who receive lecanemab 10mg/kg every two weeks for 18 months
  • Active Comparator: Lecanemab non-admnistration group
    Patients who do not receive lecanemab

Primary Outcome Measure

Changes in amyloid dposition on amyloid imaging scans [ Time Frame: Change from baseline to 18 months ]

Central Contacts

Related Studies