The PRISMS Study: A Yale-Led Clinical Trial for Parkinson's Disease Prevention in persons with RBD

PRISMS is a clinical trial led by Dr. Jesse Cedarbaum of Yale School of Medicine's Movement Disorders Division, in collaboration with the Parkinson Study Group (PSG), a network of clinical sites dedicated to Parkinson's disease research. PRISMS stands for 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).

The purpose of this study is to determine if a drug called adalimumab can reduce or prevent emergence or progression of synuclein-related neurodegeneration, or nerve cell death that causes Parkinson’s Disease or Dementia with Lewy Bodies, in people with REM Sleep Behavior Disorder. Your voluntary participation in this Parkinson's disease prevention clinical trial would help researchers understand the progression of RBD into neurodegenerative disorders such as Parkinson's disease or Lewy Body Dementia, and the effect of adalimumab injections, if any, on that process, compared to placebo.

PRISMS is a Parkinson's disease prevention clinical trial for people diagnosed with REM Sleep Behavior Disorder (RBD), a condition strongly linked to future risk of Parkinson's disease and related synucleinopathies. Led by Dr. Jesse Cedarbaum, a neurologist at Yale, the study is evaluating whether early immune-targeted treatment can delay or prevent that progression.

Participants who enroll in the PRISMS study at Yale and 14 other centers in North America will be randomly assigned to either active study drug or placebo for a period of 2 years. During the study, participants will undergo study assessments, questionnaires, lab tests, and imaging.

• There are currently no treatments that can prevent or even slow the progression of Parkinson’s disease or Dementia with Lewy Bodies
• The PRISMS trial is unique in that the medication being tested is designed to modify the body’s immune system to better defend against the onset of PD and DLB
• Scientists need your help to better understand and test new treatment approaches. Without your participation, science and medicine cannot advance in the fight against neurodegenerative disorders