Amyloid Monoclonal Antibody Treatment in PD Patients With Coexistent AD Pathology
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lecanemab, Lecanemab non-administration group.
- Who it may be relevant to
- Registry conditions: Parkinson Disease. Basic parameters: 50 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Lecanemab in Patients With Parkinson's Disease With Coexistent Alzheimer's Disease
Overview
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.
Detailed description
This study plans to consecutively enroll the patients with Parkinson's disease (PD) who have confirmed amyloid deposition on amyloid imaging and meet the indications for lecanemab administration. After a thorough explanation of lecanemab administration, patients who consent to the treatment would be enrolled. Patients assinged to the treatment arm would receive standard lecanemab treatment (10mg/kg intravenous infusion every two weeks for 18 months) and standard PD care. Patients who do not consent to the administration of lecanemab would receive stadnard care for PD and be monitored their progress without any further intervention.
Interventions
- Drug Lecanemab
Patients assigned to this arm receive lecanemab 10mg/kg intravenously every two weeks for 18 months. - Other Lecanemab non-administration group
Patients assigned to this arm do not receive lecanemab 10mg/kg intravenously during the follow-up period
Primary outcome measures
- Changes in amyloid dposition on amyloid imaging scans [Time frame: Change from baseline to 18 months]
Secondary outcome measures (7)
- longitudinal changes in the MMSE score [Time frame: Change from baseline to 18 months]
- longituidnal changes in UPDRS-III scores. [Time frame: Change from baseline to 18 months]
- Longitudinal changes in the plasma and cerebrospinal fluid biomarkers [Time frame: Change from baseline to 18 months]
- longitudinal changes in the MoCA score. [Time frame: Change from baseline to 18 months]
- longitudinal changes in CDR-SB. [Time frame: Change from baseline to 18 months]
- longituidnal changes in composite scores of each cognitive domain. [Time frame: Change from baseline to 18 months]
- longituidnal changes in levodopa-equivalent doses per body weight [mg/kg]. [Time frame: Change from baseline to 18 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Yonsei University College of Medicine — Seoul
Identifiers
NCT: NCT07544953 · 4-2025-1358