Amyloid Monoclonal Antibody Treatment in PD Patients With Coexistent AD Pathology
ConditionParkinson Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-90
SponsorYonsei University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Lecanemab
DrugPatients assigned to this arm receive lecanemab 10mg/kg intravenously every two weeks for 18 months.
Lecanemab non-administration group
Other interventionPatients assigned to this arm do not receive lecanemab 10mg/kg intravenously during the follow-up period
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Lecanemab admnistration groupExperimental treatment 1 intervention
Group B: Lecanemab non-admnistration groupActive comparator 1 intervention
Trial outcomes
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
Time frame
Change from baseline to 18 monthsSecondary outcomes
1
longitudinal changes in the MMSE score
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.
Time frame
Change from baseline to 18 months2
longituidnal changes in UPDRS-III scores.
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.
Time frame
Change from baseline to 18 months3
Longitudinal changes in the plasma and cerebrospinal fluid biomarkers
Longitudinal changes in the plasma and cerebrospinal fluid biomarkers regarding the Alzheimer's disease in the lecanemab administration group.
Time frame
Change from baseline to 18 months4
longitudinal changes in the MoCA score.
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.
Time frame
Change from baseline to 18 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: