A Clinical Study of the Efficacy of Idebenone in the Treatment of iRBD Into Synucleinopathies

Launched by RUIJIN HOSPITAL · Aug 26, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a medication called Idebenone for treating patients with a condition known as idiopathic REM Sleep Behavior Disorder (iRBD). This condition can lead to more serious problems known as synucleinopathies, which affect the brain and can cause issues like movement difficulties. The trial will include 142 participants aged between 40 and 75 who have been diagnosed with iRBD. To take part, individuals must be willing to sign a consent form and not have certain other health conditions, such as sleep apnea or significant neurological diseases.

Participants in the trial will be randomly assigned to either receive Idebenone or a placebo (a non-active treatment) for five years. Throughout this time, their progress will be monitored through questionnaires, blood tests, and brain scans to see if the treatment helps delay the progression of their disorder into more serious conditions. The study aims to confirm whether Idebenone is a safe and effective way to manage iRBD. If you're considering participating, you'll be contributing to important research that could help others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Clinical diagnosed of iRBD.
• • 2. Age between 40 and 75.
• • 3. Be voluntarily to participate in the experiment by signing an informed consent form.
• Exclusion Criteria:
• • 1. Sleep apnea hypopnea syndrome
• • 2. Slow movement, muscle rigidity, tremor or postural instability.
• • 3. Neurological diseases such as cerebral hemorrhage, cerebral infarction, brain trauma, brain tumor or central nervous system infection.
• • 4. Other sleep disorders or seizures.
• • 5. Alcoholism or drug addiction patients.