Parkinson DiseaseNCT07544953
Amyloid Monoclonal Antibody Treatment in PD Patients With Coexistent AD Pathology
A study testing Lecanemab and Lecanemab non-administration group in people with Parkinson Disease, run by Yonsei University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Lecanemab and Lecanemab non-administration group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2026to Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Yonsei University College of Medicine
Seoul
Phil Hyu Lee, MD, +82-2-2228-1608, phlee@yuhs.ac
About this study
Official title: Efficacy of Lecanemab in Patients With Parkinson's Disease With Coexistent Alzheimer's Disease
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Lecanemab, Lecanemab non-administration group
- Keywords
- Parkinson disease, amyloid, lecanemab
- Medical subject headings
- Parkinson Disease, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LecanemabDrug
Patients assigned to this arm receive lecanemab 10mg/kg intravenously every two weeks for 18 months.
Lecanemab non-administration groupOther
Patients assigned to this arm do not receive lecanemab 10mg/kg intravenously during the follow-up period
| Study group | Role | What they receive |
|---|---|---|
| Lecanemab admnistration group | Experimental | Patients who receive lecanemab 10mg/kg every two weeks for 18 months Receives: Drug: Lecanemab |
| Lecanemab non-admnistration group | Active comparator | Patients who do not receive lecanemab Receives: Other: Lecanemab non-administration group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline to 18 months
Secondary outcomes (7)
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.
Measured: Change from baseline to 18 months
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.
Measured: Change from baseline to 18 months
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.
Measured: Change from baseline to 18 months
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.
Measured: Change from baseline to 18 months
longitudinal changes in CDR-SB.
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.
Measured: Change from baseline to 18 months
longituidnal changes in composite scores of each cognitive domain.
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.
Measured: Change from baseline to 18 months
longituidnal changes in levodopa-equivalent doses per body weight [mg/kg].
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.
Measured: Change from baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study startMay 2026 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544953
- Sponsor's protocol ID
- 4-2025-1358
- Status last verified
- Apr 2026
- First submitted
- 21 Dec 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lecanemab in Patients With Parkinson's Disease With Coexistent Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07544953
- Acronym / sponsor ID
- 4-2025-1358
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, amyloid, lecanemab
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lecanemab admnistration group | Experimental | Drug: LecanemabPatients who receive lecanemab 10mg/kg every two weeks for 18 months |
| Lecanemab non-admnistration group | Active comparator | Other: Lecanemab non-administration groupPatients who do not receive lecanemab |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LecanemabPatients assigned to this arm receive lecanemab 10mg/kg intravenously every two weeks for 18 months. | Drug | Lecanemab admnistration group |
| Lecanemab non-administration groupPatients assigned to this arm do not receive lecanemab 10mg/kg intravenously during the follow-up period | Other | Lecanemab non-admnistration group |
Primary outcome
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
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lecanemab and Lecanemab non-administration group in people with Parkinson Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Phil Hyu Lee, MD (82-2-2228-1608, phlee@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in amyloid dposition on amyloid imaging scans (time frame: Change from baseline to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.