Parkinson Disease, REM Sleep Behavior Disorder, Synucleinopathies
Conditions
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).
Interventions
DRUGRasagiline
1 mg rasagiline
Sponsors
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
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Striatal dopaminergic innervation | 0-3 years after starting rasagiline treatment | Striatal binding ratio from DAT-Scan |
| 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 | — |
| HAMD | 0-3 years after starting rasagiline treatment | — |
Outcome results
None listed