Parkinson Disease, REM Sleep Behavior Disorder
Conditions
Brief summary
To investigate whether 24 months of idebenone may reduce the progression from Prodromal Parkinson disease (PPD) to Parkinson disease (PD).
Detailed description
Number of people suffered from Parkinson disease (PD) is increasing every year. Contemporary medication has little neuroprotective effect, which may due to delayed treatment as over 50% neurons have lost when clinical diagnosed PD emerges. The concept of Prodromal Parkinson disease (PPD) is emphasized as it has become evident that there are several risk and clinical markers may occur years before the cardinal motor symptoms which allow clinical diagnosis. Rapid eye movement (REM) sleep behavior disorder and olfactory dysfunction are the most common PPD, and more than one third of patients may progress to PD and other neurodegenerative diseases. Mitochondrial injury is one of the pathogenesis of PD. Thus we design this trial to investigate whether idebenone, potent coenzyme Q10 analogue, could protect PPD develops into PD.
Interventions
DRUGIdebenone
30mg tablets three times a day
DRUGPlacebo oral tablet
placebo tablets three times a day
Sponsors
Peking Union Medical College Hospital
Beijing Hospital
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
Tongji Hospital
Second Affiliated Hospital of Soochow University
Guizhou Medical University
The First Affiliated Hospital of Guangzhou Medical University
Peking University Shenzhen Hospital
West China Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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
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
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects are voluntary to participate and have signed informed consent * Diagnosed as Rapid Eye movement (REM) Sleep Behavior Disorder by polysomnography
Exclusion criteria
* Subjects are pregnant, breastfeeding, or want to get pregnant or breastfeeding in 2 years * Subjects have history of allergy to idebenone * Difficulty to communicate * Suffering from neurodegenerative diseases * Having obvious brain imaging abnormalities (eg. severe brain atrophy, malformation, softening lesions, cerebrovascular disease, intracranial occupancy, giant large benign lesions, etc.) * Having severe mental illness (eg. schizophrenia, manic depression, and severe depression) * Long-term use of clonidine, dopamine antagonists, and serotonin reuptake inhibitors * Suffering from other severe medical conditions * Having difficulty in moving and are unable to come to the hospital * Having claustrophobia * Having contraindications to MRI tests * Having history of olfactory disorders greater than 10 years * Having history of color vision disorders greater than 10 years * Life expectancy less than 2 years * Having other situations which researchers consider is inappropriate to participate in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical diagnosis of parkinson disease | 24 months | based on Movement Disorder Society (MDS) Research Criteria for Prodromal Parkinson's Disease in 2015 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dopamine transporter positron emission tomography (DAT-PET) change | 12 month and 24 month | diminishment of striatal DAT-PET |
| Quantitative motor testing change | 24 months | Unified Parkinson Disease Rating Scale, Part III |
Countries
China
Outcome results
None listed