Clinical trial NCT05611372: 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
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: REM Sleep Behavior Disorder
Parkinson Disease
Synucleinopathies
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Jiangsu Province Nanjing Brain Hospital
name: The First Affiliated Hospital of Anhui Medical University
name: Huashan Hospital
name: Second Affiliated Hospital of Soochow University
name: Guizhou Medical University
name: The First Affiliated Hospital of Guangzhou Medical University
name: West China Hospital
name: Sir Run Run Shaw Hospital
name: The Affiliated Hospital of Hangzhou Normal University
name: The First Affiliated Hospital of Dalian Medical University
name: Qilu Hospital of Shandong University
name: Fujian Medical University Union Hospital
First posted: 2022-11-10
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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)

Primary outcomes:
measure: Disease-free survival time
timeFrame: 3 years after starting rasagiline treatment
Secondary outcomes:
measure: Striatal dopaminergic innervation
timeFrame: 0-3 years after starting rasagiline treatment
measure: MDS-UPDRS-III
timeFrame: 0-3 years after starting rasagiline treatment
measure: MoCA
timeFrame: 0-3 years after starting rasagiline treatment
measure: MMSE
timeFrame: 0-3 years after starting rasagiline treatment
measure: HAMA
timeFrame: 0-3 years after starting rasagiline treatment
measure: HAMD
timeFrame: 0-3 years after starting rasagiline treatment
measure: RBDQ-HK
timeFrame: 0-3 years after starting rasagiline treatment
measure: PSQI
timeFrame: 0-3 years after starting rasagiline treatment
measure: PDQ39
timeFrame: 0-3 years after starting rasagiline treatment
measure: SCOPA-AUT
timeFrame: 0-3 years after starting rasagiline treatment
Other outcomes:
Locations:
Study officials:
affiliation: Second Affiliated Hospital, Zhejiang University, China
name: Baorong Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: