Clinical trialNCT06996652RecruitingPhase 2Interventional

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)

SponsorYale UniversityEnrollment108REM Sleep Behavior Disorder

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Jesse Cedarbaum, MD
Yale University
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

19 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

Montreal Neurological Institute-Hospital at Mcgill University
Montreal, Quebec, Canada
Anne-Louise Lafontaine, MDMassimo Pandolfo, MDRonald B Postuma, MD
Not, yet, recruiting

United States

Cedars Sinai Medical Center
Los Angeles, California, United States
Camille Malatt, MDEcho E Tan, MDElliot Hogg, MDMichele Tagliati, MDYvette Bordelon, MD, PhD
Not, yet, recruiting
University of Colorado Anschutz
Aurora, Colorado, United States
Alexander Baumgartner, MDAmy Amara, MD, PhDJeanne Feuerstein, MD
Recruiting
Yale Medicine
North Haven, Connecticut, United States
Hae-Young Hawong, DO, PhDVeronica Santini, MD, MA
Not, yet, recruiting
Parkinson'S Disease & Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
Jonathan Isaacson, MDRichard Dewey III, MDSagari Bette, MDStuart Isaacson, MD
Not, yet, recruiting
Emory University School of Medicine
Atlanta, Georgia, United States
Kendall Nichols, MDLynne Marie Trotti, MD, MSc
Not, yet, recruiting
Johns Hopkins University
Baltimore, Maryland, United States
Emile Moukheiber, MDKelly Mills, MD
Not, yet, recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Lan Luo, MD, MSMonica Makhija, MD
Not, yet, recruiting
Massachusetts General Hospital
Boston, Massachusetts, United States
Aleksandar Videnovic, MD, MSc
Recruiting
University of Minnesota
Minneapolis, Minnesota, United States
Michael Howell, MD
Not, yet, recruiting
Washington University
St Louis, Missouri, United States
Joel S. Perlmutter, MDScott Norris, MD
Not, yet, recruiting
Cleveland Clinic Lou Ruvo Center for Brain Health - Las Vegas
Las Vegas, Nevada, United States
Zoltan Mari, MD
Not, yet, recruiting
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Glen Greenough, MDMarc Seltzer, MDMary Feldman, DOStephen Lee, MD, PhD
Not, yet, recruiting
Weill Medical College of Cornell University
New York, New York, United States
Andrea Yoo, MDHarini Sarva, MDMoath Hamed, MDNatalie Hellmers, NP
Not, yet, recruiting
Oregon Health & Science University
Portland, Oregon, United States
Delaram Safarpour, MDJoseph Quinn, MDMatthew Brodsky, MD
Not, yet, recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Gavin Villacorta, CRNPNabila Dahodwala, MD, MS
Not, yet, recruiting
Medical University of South Carolina
Charleston, South Carolina, United States
Christine Cooper, MDChrstine Dziwis, MD
Not, yet, recruiting
University of Texas Houston Medical Center
Houston, Texas, United States
Chiamaka Onuigbo, MDEmily Tharp, MDMya C Schiess, MDSudha S Tallavajhula, MD
Not, yet, recruiting
University of Texas Health Science Center- San Antonio
San Antonio, Texas, United States
Cynthia Cornejo, PA-COkeanis Vaou, MD
Not, yet, recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Adalimumab →Placebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 17 Aug 2026
Primary completion: 1 Aug 2029
Completion: 1 Jan 2030
Last update posted: 19 Aug 2026
Registered enrollment: 108
Registry id: NCT06996652

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.