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)
Yale University
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.
Description
Primary Objective: 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). Secondary Objective, Safety: Safety will be assessed by monitoring the Incidence of adverse events, clinical laboratory abnormalities, serious infections, signs and symptoms suggestive of new onset demyelinating disease, incidence of new demyelinating lesions on brain MRI scan and number of study participants who develop serum anti-adalimumab antibodies (ADAs). Secondary Objective, C…
Eligibility
- Age range
- 50–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Males, or females who are either 1. post-menopausal or otherwise not of child-bearing potential, defined as either 1) having had no menses for 12 or months without an alternative medical cause or explanation or 2) having undergone a surgical procedure (hysterectomy, bilateral tubal ligation) that prevents conception, or 2. practicing adequate contraception. Female subjects of childbearing potential must practice at least 1 protocol-specified method of birth control, that is effective from 30 days before baseline (or earlier) through at least 150 days after the last…
Interventions
- DrugAdalimumab
40 mg self-administered subcutaneously using a pre-filled syringe (PFS) every 2 weeks for up to 2 years
- DrugPlacebo
40 mg matching placebo self-administered subcutaneously using a pre-filled syringe (PFS) every 2 weeks for up to 2 years
Locations (20)
- Cedars Sinai Medical CenterLos Angeles, California
- University of Colorado AnschutzAurora, Colorado
- Yale MedicineNorth Haven, Connecticut
- Parkinson's Disease & Movement Disorders Center of Boca RatonBoca Raton, Florida
- Emory University School of MedicineAtlanta, Georgia
- Johns Hopkins UniversityBaltimore, Maryland