Efficacy and Safety of Rasagiline in Prodromal Parkinson's Disease

NCT05611372 | Withdrawn Phase 2

• 1 other identifier: SAHZJU_RBD
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

REM Sleep Behavior Disorder; Parkinson Disease; Synucleinopathies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Striatal dopaminergic innervation

  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

Study Arms (2)

Early Intervention

EXPERIMENTAL

0-52 week: rasagiline 1 mg/day

Drug: Rasagiline

Delayed Intervention

ACTIVE COMPARATOR

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

Drug: Rasagiline

Interventions

Rasagiline DRUG

1 mg rasagiline

Delayed Intervention; Early Intervention

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

MeSH Terms

Conditions

REM Sleep Behavior Disorder; Parkinson Disease; Synucleinopathies

Interventions

rasagiline

Condition Hierarchy (Ancestors)

REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Baorong Zhang, MD

  Second Affiliated Hospital, Zhejiang University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2022
• First Posted: November 10, 2022
• Study Start: January 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 7, 2025

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share