Parkinson Disease
Conditions
Keywords
Parkinson disease, amyloid, lecanemab
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.
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
DRUGLecanemab
Patients assigned to this arm receive lecanemab 10mg/kg intravenously every two weeks for 18 months.
OTHERLecanemab non-administration group
Patients assigned to this arm do not receive lecanemab 10mg/kg intravenously during the follow-up period
Sponsors
Yonsei University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in amyloid dposition on amyloid imaging scans | Change from baseline to 18 months | Changes in amyloid dposition (i.e., global FBB SUVR) on amyloid imaging scans (18F-FBB PET) after lecanemab administration in the lecanemab adminstration group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| longitudinal changes in the MMSE score | Change from baseline to 18 months | The change in Mini-Mental State Examination (MMSE) score from baseline to 18 months will be compared between the lecanemab administration group and the non-administration group. |
| longituidnal changes in UPDRS-III scores. | Change from baseline to 18 months | The change in Unified Parkinson's Disease Rating Scale Part III (UPDRS-III) score from baseline to 18 months will be compared between the lecanemab administration group and the non-administration group. |
| Longitudinal changes in the plasma and cerebrospinal fluid biomarkers | Change from baseline to 18 months | Longitudinal changes in the plasma and cerebrospinal fluid biomarkers regarding the Alzheimer's disease in the lecanemab administration group. |
| longitudinal changes in the MoCA score. | Change from baseline to 18 months | The change in Montreal Cognitive Assessment (MoCA) score from baseline to 18 months will be compared between the lecanemab administration group and the non-administration group. |
| longitudinal changes in CDR-SB. | Change from baseline to 18 months | The change in Clinical Dementia Rating-Sum of Boxes (CDR-SB) score from baseline to 18 months will be compared between the lecanemab administration group and the non-administration group. |
| longituidnal changes in composite scores of each cognitive domain. | Change from baseline to 18 months | The change in composite scores of cognitive domains from baseline to 18 months will be compared between the lecanemab administration group and the non-administration group. |
| longituidnal changes in levodopa-equivalent doses per body weight [mg/kg]. | Change from baseline to 18 months | The change in levodopa-equivalent dose (LED) from baseline to 18 months will be compared between the lecanemab administration group and the non-administration group. |
Countries
South Korea
Contacts
CONTACTPhil Hyu Lee, MD
Outcome results
None listed