Clinical Trial

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)

Study acronym: PRISMS

Recruiting Phase 2

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.

Protocol Amendment History 7 changes

critical Recruitment opened 2026-07-24

notable Primary completion pushed: 2029-01-28 -> 2029-08-01 2026-07-01

minor Completion moved earlier: 2030-06-28 -> 2029-08-01 2026-07-01

notable Primary completion moved earlier: 2029-08 -> 2029-01-28 2026-06-24

minor Completion pushed: 2029-08 -> 2030-06-28 2026-06-24

notable Primary completion pushed: 2029-07 -> 2029-08 2026-04-14

minor Completion pushed: 2029-07 -> 2029-08 2026-04-14

Trial Details

NCT Number	NCT06996652
Lead Sponsor	Yale University Collaborators: The Marcus Foundation, National Institute on Aging (NIA), University of Rochester - Center for Health + Technology (CHeT)/Clinical Trials Coordinaton Center (CTCC), The Parkinson Study Group
Conditions	REM Sleep Behavior Disorder
Enrollment	108 participants
Start Date	2026-07-15
Primary Completion	2029-08-01 (estimated)
Study Completion	2029-08-01 (estimated)
Updated on ClinicalTrials.gov	2026-08-06