Amyloid Monoclonal Antibody Treatment in PD Patients With Coexistent AD Pathology

NCT07544953 | Not Yet Recruiting

• 1 other identifier: 4-2025-1358
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

Parkinson disease; amyloid; lecanemab

Outcome Measures

Primary Outcomes (1)

• Changes in amyloid dposition on amyloid imaging scans

  Changes in amyloid dposition (i.e., global FBB SUVR) on amyloid imaging scans (18F-FBB PET) after lecanemab administration in the lecanemab adminstration group

  Change from baseline to 18 months

Secondary Outcomes (7)

• longitudinal changes in the MMSE score

  Change from baseline to 18 months

• longituidnal changes in UPDRS-III scores.

  Change from baseline to 18 months

• Longitudinal changes in the plasma and cerebrospinal fluid biomarkers

  Change from baseline to 18 months

• longitudinal changes in the MoCA score.

  Change from baseline to 18 months

• longitudinal changes in CDR-SB.

  Change from baseline to 18 months

Study Arms (2)

Lecanemab admnistration group

EXPERIMENTAL

Patients who receive lecanemab 10mg/kg every two weeks for 18 months

Drug: Lecanemab

Lecanemab non-admnistration group

ACTIVE COMPARATOR

Patients who do not receive lecanemab

Other: Lecanemab non-administration group

Interventions

Lecanemab DRUG

Patients assigned to this arm receive lecanemab 10mg/kg intravenously every two weeks for 18 months.

Lecanemab admnistration group

Lecanemab non-administration group OTHER

Patients assigned to this arm do not receive lecanemab 10mg/kg intravenously during the follow-up period

Lecanemab non-admnistration group

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Conditions

Parkinson Disease; Alzheimer Disease

Interventions

lecanemab

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dementia; Tauopathies; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Phil Hyu Lee, MD

CONTACT

82-2-2228-1608; phlee@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: April 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): November 1, 2030
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)