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NCT Number: NCT07544953

Amyloid Monoclonal Antibody Treatment in PD Patients With Coexistent AD Pathology

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.

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Key information

Conditions

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

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Changes in amyloid dposition on amyloid imaging scans

    Time frame: 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 outcomes

  1. longitudinal changes in the MMSE score

    Time frame: 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.

  2. longituidnal changes in UPDRS-III scores.

    Time frame: 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.

  3. Longitudinal changes in the plasma and cerebrospinal fluid biomarkers

    Time frame: 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.

  4. longitudinal changes in the MoCA score.

    Time frame: 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.

  5. longitudinal changes in CDR-SB.

    Time frame: 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.

  6. longituidnal changes in composite scores of each cognitive domain.

    Time frame: 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.

  7. longituidnal changes in levodopa-equivalent doses per body weight [mg/kg].

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Phil Hyu Lee, MD

CONTACT

[email protected]

82-2-2228-1608

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

Efficacy of Lecanemab in Patients With Parkinson's Disease With Coexistent Alzheimer's Disease

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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