Efficacy and Safety of Rasagiline in Prodromal Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Efficacy and Safety of Rasagiline in Prodromal Parkinson's Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05611372
• Other study ID #: SAHZJU_RBD
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: January 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Baorong Zhang, MD
• Phone: 86 13958167260
• Email: brzhang[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 732
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Mental Disorders
• Parkinson Disease
• REM Sleep Behavior Disorder

Intervention

Drug:
• Rasagiline
1 mg rasagiline

Locations

Country	Name	City	State
n/a

Sponsors (15)

Lead Sponsor

Collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Striatal dopaminergic innervation	Striatal binding ratio from DAT-Scan	0-3 years after starting rasagiline treatment
Secondary	MDS-UPDRS-III		0-3 years after starting rasagiline treatment
Secondary	MoCA		0-3 years after starting rasagiline treatment
Secondary	MMSE		0-3 years after starting rasagiline treatment
Secondary	HAMA		0-3 years after starting rasagiline treatment
Secondary	HAMD		0-3 years after starting rasagiline treatment
Secondary	RBDQ-HK		0-3 years after starting rasagiline treatment
Secondary	PSQI		0-3 years after starting rasagiline treatment
Secondary	PDQ39		0-3 years after starting rasagiline treatment
Secondary	SCOPA-AUT		0-3 years after starting rasagiline treatment