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Efficacy and Safety of Rasagiline in Prodromal Parkinson's Disease

Primary Purpose

REM Sleep Behavior Disorder, Parkinson Disease, Synucleinopathies

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Rasagiline
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for REM Sleep Behavior Disorder

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: PSG confirmed RBD with subtle motor symptoms (4≤MDS-UPDRS-III≤10 at baseline) no clinical diagnosis of Parkinson's disease or dementia at baseline age 30-75 no concomitant or previous use of any other anti-parkinson medications provide written informed consent Exclusion Criteria: diagnosed with secondary parkinsonism (eg., drug-induced, vascular, psychogenic) secondary RBD (eg., drug-induced, immune-mediated) nervous system comorbidities (eg., stroke, epilepsy, encephalitis) severe psychiatric comorbidities allergic to rasagiline severe systemic diseases (eg., end-stage kidney disease, liver failure)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Early Intervention

    Delayed Intervention

    Arm Description

    0-52 week: rasagiline 1 mg/day

    0-26 week: palcebo 1mg/day 27-52 week: rasagiline 1mg/day

    Outcomes

    Primary Outcome Measures

    Disease-free survival time
    Not diagnosed as any of the synucleinopathies (Parkinson's disease; dementia with lewy body; multiple system atrophy)

    Secondary Outcome Measures

    Striatal dopaminergic innervation
    Striatal binding ratio from DAT-Scan
    MDS-UPDRS-III
    MoCA
    MMSE
    HAMA
    HAMD
    RBDQ-HK
    PSQI
    PDQ39
    SCOPA-AUT

    Full Information

    First Posted
    November 6, 2022
    Last Updated
    November 6, 2022
    Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    Collaborators
    Beijing Tiantan Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Jiangsu Province Nanjing Brain Hospital, The First Affiliated Hospital of Anhui Medical University, Huashan Hospital, Second Affiliated Hospital of Soochow University, Guizhou Medical University, The First Affiliated Hospital of Guangzhou Medical University, West China Hospital, Sir Run Run Shaw Hospital, The Affiliated Hospital of Hangzhou Normal University, The First Affiliated Hospital of Dalian Medical University, Qilu Hospital of Shandong University, Fujian Medical University Union Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05611372
    Brief Title
    Efficacy and Safety of Rasagiline in Prodromal Parkinson's Disease
    Official Title
    Efficacy and Safety of Rasagiline in Prodromal Parkinson's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    Collaborators
    Beijing Tiantan Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Jiangsu Province Nanjing Brain Hospital, The First Affiliated Hospital of Anhui Medical University, Huashan Hospital, Second Affiliated Hospital of Soochow University, Guizhou Medical University, The First Affiliated Hospital of Guangzhou Medical University, West China Hospital, Sir Run Run Shaw Hospital, The Affiliated Hospital of Hangzhou Normal University, The First Affiliated Hospital of Dalian Medical University, Qilu Hospital of Shandong University, Fujian Medical University Union Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To investigate whether a year of rasagiline may reduce the progression from idiopathic REM sleep behavior disorder (RBD) to Parkinson's disease (PD).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    REM Sleep Behavior Disorder, Parkinson Disease, Synucleinopathies

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    732 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Early Intervention
    Arm Type
    Experimental
    Arm Description
    0-52 week: rasagiline 1 mg/day
    Arm Title
    Delayed Intervention
    Arm Type
    Active Comparator
    Arm Description
    0-26 week: palcebo 1mg/day 27-52 week: rasagiline 1mg/day
    Intervention Type
    Drug
    Intervention Name(s)
    Rasagiline
    Intervention Description
    1 mg rasagiline
    Primary Outcome Measure Information:
    Title
    Disease-free survival time
    Description
    Not diagnosed as any of the synucleinopathies (Parkinson's disease; dementia with lewy body; multiple system atrophy)
    Time Frame
    3 years after starting rasagiline treatment
    Secondary Outcome Measure Information:
    Title
    Striatal dopaminergic innervation
    Description
    Striatal binding ratio from DAT-Scan
    Time Frame
    0-3 years after starting rasagiline treatment
    Title
    MDS-UPDRS-III
    Time Frame
    0-3 years after starting rasagiline treatment
    Title
    MoCA
    Time Frame
    0-3 years after starting rasagiline treatment
    Title
    MMSE
    Time Frame
    0-3 years after starting rasagiline treatment
    Title
    HAMA
    Time Frame
    0-3 years after starting rasagiline treatment
    Title
    HAMD
    Time Frame
    0-3 years after starting rasagiline treatment
    Title
    RBDQ-HK
    Time Frame
    0-3 years after starting rasagiline treatment
    Title
    PSQI
    Time Frame
    0-3 years after starting rasagiline treatment
    Title
    PDQ39
    Time Frame
    0-3 years after starting rasagiline treatment
    Title
    SCOPA-AUT
    Time Frame
    0-3 years after starting rasagiline treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: PSG confirmed RBD with subtle motor symptoms (4≤MDS-UPDRS-III≤10 at baseline) no clinical diagnosis of Parkinson's disease or dementia at baseline age 30-75 no concomitant or previous use of any other anti-parkinson medications provide written informed consent Exclusion Criteria: diagnosed with secondary parkinsonism (eg., drug-induced, vascular, psychogenic) secondary RBD (eg., drug-induced, immune-mediated) nervous system comorbidities (eg., stroke, epilepsy, encephalitis) severe psychiatric comorbidities allergic to rasagiline severe systemic diseases (eg., end-stage kidney disease, liver failure)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Baorong Zhang, MD
    Phone
    86 13958167260
    Email
    brzhang@zju.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Baorong Zhang, MD
    Organizational Affiliation
    Second Affiliated Hospital, Zhejiang University, China
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Efficacy and Safety of Rasagiline in Prodromal Parkinson's Disease

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