drugset / Trial / NCT06996652
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)
Phase 2
Not yet recruiting
108 enrolled
Yale University
National Institute on Aging (NIA) · collabThe Marcus Foundation · collab
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2026-06-29
- Primary completion
- 2029-08-01
- Completion
- 2029-08-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Adalimumab | Monoclonal antibody | 40 mg | Subcutaneous |