Efficacy and Safety of Rasagiline in Prodromal Parkinson's Disease

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

Study Overview

• Status: Withdrawn
• Conditions: Parkinson Disease; Synucleinopathies; REM Sleep Behavior Disorder
• Intervention / Treatment: Drug: Rasagiline

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Striatal dopaminergic innervation	Striatal binding ratio from DAT-Scan	0-3 years after starting rasagiline treatment
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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: The First Affiliated Hospital of Anhui Medical University; Beijing Tiantan Hospital; Huashan Hospital; West China Hospital; Qilu Hospital of Shandong University; Guizhou Medical University; The First Affiliated Hospital of Guangzhou Medical University; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; Fujian Medical University Union Hospital; Sir Run Run Shaw Hospital; Second Affiliated Hospital of Soochow University; The First Affiliated Hospital of Dalian Medical University; The Affiliated Hospital of Hangzhou Normal University; Jiangsu Province Nanjing Brain Hospital
• Investigators: Principal Investigator: Baorong Zhang, MD, Second Affiliated Hospital, Zhejiang University, China

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 6, 2022
• First Submitted That Met QC Criteria: November 6, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 5, 2025
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Neurodegenerative Diseases; Sleep Wake Disorders; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Proteostasis Deficiencies; Parasomnias; REM Sleep Parasomnias; Synucleinopathies; Mental Disorders; Parkinson Disease; REM Sleep Behavior Disorder; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protective Agents; Monoamine Oxidase Inhibitors; Neuroprotective Agents; Rasagiline
• Other Study ID Numbers: SAHZJU_RBD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No