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)
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.
• Males, or females who are either
‣ 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
⁃ practicing adequate contraception. Female participants 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 dose of the study drug. Female participants of non-childbearing potential do not need to use birth control.
⁃ women of childbearing potential must have a negative urine pregnancy test prior to enrollment, and agree to undergo a pregnancy test at each study visit. Women with a positive pregnancy test at screening or at any subsequent study visit will be withdrawn from the study.
• Diagnosis of idiopathic REM Sleep Behavior Disorder (RBD) based upon:
‣ History of Dream Enactment Behavior during sleep and
⁃ Evidence of REM sleep without muscle atonia based upon polysomnogram obtained in a qualified sleep laboratory, consistent with ICSD-3 Diagnostic Criteria for RBD
• Hyposmia, defined as score \< 15th percentile for age-and gender-specific normal values
• Not diagnosed with motor Parkinson's Disease or Lewy Body Dementia
• Have a MoCA score at screening and baseline ≥23
• Able to speak, read and write fluently in the official language of the site's geographical region
• Participant must be willing and able to attend all study visits as required by the study protocol
• Participant must have a study partner who is in regular contact with the subject and can accompany the subject to clinic visits and report on subject's functional status
• Participant must be able to self-inject study drug regularly or have a study partner who is available, willing and able to do so
• Participant must be able to understand the study requirements and provide written informed consent