A Study of Efficacy and Safety of Idebenone vs. Placebo in Prodromal Parkinson Disease

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate whether 24 months of idebenone may reduce the progression from Prodromal Parkinson disease (PPD) to Parkinson disease (PD).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Beijing Hospital; Beijing Tiantan Hospital; Guizhou Medical University; Huashan Hospital; Jiangsu Province Nanjing Brain Hospital; Peking Union Medical College Hospital; Peking University Shenzhen Hospital; Qilu Hospital of Shandong University; Second Affiliated Hospital of Soochow University; Sir Run Run Shaw Hospital; The Affiliated Hospital of Hangzhou Normal University; The First Affiliated Hospital of Anhui Medical University; The First Affiliated Hospital of Dalian Medical University; The First Affiliated Hospital of Guangzhou Medical University; Tongji Hospital; West China Hospital; Wuhan Union Hospital, China; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Treatments: Coenzyme Q10; Idebenone; Ubiquinone

Criteria

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