Efficacy and Safety of Rasagiline in Prodromal Parkinson's Disease

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05611372

Collaborator

Beijing Tiantan Hospital (Other), Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other), Jiangsu Province Nanjing Brain Hospital (Other), The First Affiliated Hospital of Anhui Medical University (Other), Huashan Hospital (Other), Second Affiliated Hospital of Soochow University (Other), Guizhou Medical University (Other), The First Affiliated Hospital of Guangzhou Medical University (Other), West China Hospital (Other), Sir Run Run Shaw Hospital (Other), The Affiliated Hospital of Hangzhou Normal University (Other), The First Affiliated Hospital of Dalian Medical University (Other), Qilu Hospital of Shandong University (Other), Fujian Medical University Union Hospital (Other)

732

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
REM Sleep Behavior Disorder Parkinson Disease Synucleinopathies	Drug: Rasagiline	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

732 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Rasagiline in Prodromal Parkinson's Disease

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Early Intervention 0-52 week: rasagiline 1 mg/day	Drug: Rasagiline 1 mg rasagiline
Active Comparator: Delayed Intervention 0-26 week: palcebo 1mg/day 27-52 week: rasagiline 1mg/day	Drug: Rasagiline 1 mg rasagiline

Arm

Intervention/Treatment

Experimental: Early Intervention

0-52 week: rasagiline 1 mg/day

Drug: Rasagiline

1 mg rasagiline

Active Comparator: Delayed Intervention

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

Drug: Rasagiline

1 mg rasagiline

Outcome Measures

Primary Outcome Measures

Disease-free survival time [3 years after starting rasagiline treatment]
Not diagnosed as any of the synucleinopathies (Parkinson's disease; dementia with lewy body; multiple system atrophy)

Secondary Outcome Measures

Striatal dopaminergic innervation [0-3 years after starting rasagiline treatment]
Striatal binding ratio from DAT-Scan
MDS-UPDRS-III [0-3 years after starting rasagiline treatment]
MoCA [0-3 years after starting rasagiline treatment]
MMSE [0-3 years after starting rasagiline treatment]
HAMA [0-3 years after starting rasagiline treatment]
HAMD [0-3 years after starting rasagiline treatment]
RBDQ-HK [0-3 years after starting rasagiline treatment]
PSQI [0-3 years after starting rasagiline treatment]
PDQ39 [0-3 years after starting rasagiline treatment]
SCOPA-AUT [0-3 years after starting rasagiline treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University
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

Investigators

Principal Investigator: Baorong Zhang, MD, Second Affiliated Hospital, Zhejiang University, China

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT05611372

Other Study ID Numbers:

SAHZJU_RBD

First Posted:

Nov 10, 2022

Last Update Posted:

Nov 10, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Parkinson Disease

REM Sleep Behavior Disorder

Synucleinopathies

Mental Disorders

Rasagiline

Study Results

No Results Posted as of Nov 10, 2022