Adalimumab for REM Sleep Behavior Disorder

(PRISMS Trial)

Overseen By Deanna Sgambato, DMS, PA-C

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Yale University

Must not be taking: Anti-Parkinson, Cognitive enhancers, Antipsychotics, Immunosuppressants

Disqualifiers: Neurologic disorders, Autoimmune disease, Infections, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 96 weeks

108 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jesse Cedarbaum, MD

Principal Investigator

Yale University

Eligibility Criteria

This trial is for individuals with idiopathic REM Sleep Behavior Disorder, who may be at risk of developing synucleinopathies like Parkinson's disease. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.

Inclusion Criteria

MoCA score at screening and baseline >23

Able to understand the study requirements and provide written informed consent

I have been diagnosed with REM sleep behavior disorder.

Exclusion Criteria

MRI evidence of more than three lacunar infarcts, territorial infarct, or deep white matter lesions corresponding to a Fazekas score of 3

Participation in other interventional clinical trials or treatment with investigational drugs within 30 days prior to the first Screening visit

History of drug or alcohol abuse within the last 5 years

Timeline

Screening

Participants are screened for eligibility to participate in the trial

12 weeks

Treatment

Participants receive adalimumab or placebo every 2 weeks for up to 2 years

96 weeks

Visits at 4, 12, 26 weeks, and then every 26 weeks

Follow-up

A safety follow-up visit occurs 70 days after the last dose of study treatment

10 weeks

Treatment Details

Interventions

• Adalimumab

Trial Overview The study is testing whether adalimumab can slow or prevent neurodegeneration associated with synucleinopathies in RBD patients. It's a phase 2 trial comparing adalimumab against a placebo, using PET imaging to measure changes in brain patterns related to Parkinson's disease.

Participant Groups

Group I: Adalimumab Experimental Treatment 1 Intervention

Participants in this arm will receive Adalimumab every 2 weeks for up to 2 years

Group II: Placebo Placebo Group 1 Intervention

Participants in this arm will receive matching placebo every 2 weeks for up to 2 years

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

The Marcus Foundation

Collaborator

Trials

19

Recruited

2,200+