RecruitingPhase 2NCT06996652

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)


Sponsor

Yale University

Enrollment

108 participants

Start Date

Jul 15, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase 2 study to assess the ability of adalimumab as compared to placebo to reduce or prevent progression of synuclein-related neurodegeneration in persons with idiopathic REM Sleep Behavior Disorder (RBD). The Primary Endpoint will be change from baseline in expression of the Parkinson Disease Related Pattern (PDRP) will be assessed using change in 18-flurodeoxyglucose (FDG) Positron Emission Tomography (PET) imaging.


Eligibility

Min Age: 50 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Adalimumab and a drug called Placebo for people with rem sleep behavior disorder. The study is currently recruiting participants at 20 locations. People eligible for this study include aged 50 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdalimumab

40 mg self-administered subcutaneously using a pre-filled syringe (PFS) every 2 weeks for up to 2 years

DRUGPlacebo

40 mg matching placebo self-administered subcutaneously using a pre-filled syringe (PFS) every 2 weeks for up to 2 years


Locations(20)

Cedars Sinai Medical Center

Los Angeles, California, United States

University of Colorado Anschutz

Aurora, Colorado, United States

Yale Medicine

North Haven, Connecticut, United States

Parkinson's Disease & Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Johns Hopkins University

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Washington University

St Louis, Missouri, United States

Cleveland Clinic Lou Ruvo Center for Brain Health - Las Vegas

Las Vegas, Nevada, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Weill Medical College of Cornell University

New York, New York, United States

Oregon Health & Science University

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of Texas Houston Medical Center

Houston, Texas, United States

University of Texas Health Science Center- San Antonio

San Antonio, Texas, United States

Montreal Neurological Institute-Hospital at McGill University

Montreal, Quebec, Canada

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NCT06996652


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