A Clinical Study of the Efficacy of Idebenone in the Treatment of iRBD Into Synucleinopathies
Status:
Not yet recruiting
Trial end date:
2026-09-30
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Ruijin Hospital
Collaborators:
Second Affiliated Hospital of Soochow University Wuhan Union Hospital, China