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| Name | Class |
|---|---|
| Second Affiliated Hospital of Soochow University | OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
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142 cases of patients with iRBD will be recruited from the neurology department of Ruijin Hospital, th second Affiliated Hospital of Soochow University and wuhan Union Hospital. After the informed consent was signed, they were divided into a trial group and a control group randomly. Each group contains 71 cases. The patients in the trial group will be treated with Idebenone, while the patients in the control group was treated with placebo. Both groups of subjects will be treated for 5 years, and patients will be followed-up and evaluated in the first year, 3 years and 5 years after treatment. The observations include the MDS-UPDRS questionnaires evaluation, blood biomarker measurements and fMRI or PET-MR examination to make sure whether the patients has converted to synucleinopathies. Study hypothesis: Idebenone therapy for patients with iRBD is safe and effective in delaying disease progression into synucleinopathies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| trial group | Experimental | Idebenone |
|
| control group | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Idebenone | Drug | trial group |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Effective | 5-year conversion rate of iRBD patients to synucleinopathies decreased | 5 years |
| Ineffective | 5-year conversion rate of iRBD patients to synucleinopathies remained unchanged or increased. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36172027 | Derived | Li Y, Wang C, Luo N, Chen F, Zhou L, Niu M, Kang W, Liu J. Efficacy of idebenone in the Treatment of iRBD into Synucleinopathies (EITRS): rationale, design, and methodology of a randomized, double-blind, multi-center clinical study. Front Neurol. 2022 Sep 12;13:981249. doi: 10.3389/fneur.2022.981249. eCollection 2022. |
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| ID | Term |
|---|---|
| D020187 | REM Sleep Behavior Disorder |
| D000080874 | Synucleinopathies |
| ID | Term |
|---|---|
| D020923 | REM Sleep Parasomnias |
| D020447 | Parasomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C036619 | idebenone |
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| Drug |
control group |
|
| D001523 |
| Mental Disorders |
| D019636 | Neurodegenerative Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |