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An Exploratory Study of the Potential for Rational Immune System Manipulation to Prevent Emergence of Synucleinopathy Manifestations in Persons With REM Sleep Behavior Disorder (RBD)

Studying immune system effects on sleep disorder symptoms.

Recruiting
50-80 years
All
Phase 2

This study looks at using a medicine called adalimumab to see if it can help people with a sleep problem called REM Sleep Behavior Disorder (RBD). RBD is when people act out their dreams because they lack muscle relaxation during sleep. The study will compare adalimumab with a placebo (a fake treatment) to check if it can slow down brain changes related to synucleinopathy, which can lead to diseases like Parkinson's Disease. Researchers will use a special brain scan called FDG-PET to see changes in brain activity.

Key Points:

  • The study lasts about 2 years, with visits every 4 to 24 weeks.
  • Participants will need to wear a sensor at home for 7 days every 6 months to track sleep.
  • Some participants will have a cerebrospinal fluid test to study brain changes.

To join, participants must have RBD, have a study partner, and be able to inject the study drug. Women must not be pregnant or breastfeeding. People with certain health issues, or those taking specific medications, cannot participate. Participants will be monitored for safety and changes in their condition throughout the study.

Study details
    REM Sleep Behavior Disorder

NCT06996652

Yale University

30 August 2026

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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