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 Women with a positive pregnancy test at screening or at any subsequent study visit will be withdrawn from the study.
Women who are pregnant, planning to become pregnant, or currently breastfeeding
Alternative explanation or etiology for the presence of RBD (e.g. narcolepsy)
Other than RBD, neurologic or medical disorder which may impair cognition including: head trauma, seizure disorder, neurodegenerative disease, hydrocephalus, cerebral/spinal hematoma, inflammatory disease, CNS infection (e.g., encephalitis or meningitis), neoplasm, toxic exposure, metabolic disorder (including hypoxic or hypoglycemic episodes), or endocrine disorder, or any significant medical conditions that, in the opinion of the investigator, would prohibit their participation in the study.
As assessed by the central reader, MRI evidence of (a) more than three lacunar infarcts, (b) territorial infarct or macroscopic hemorrhage, or (c) deep white matter lesions corresponding to a Fazekas score of 3
Parallel
Adalimumab
Drug40 mg self-administered subcutaneously using a pre-filled syringe (PFS) every 2 weeks for up to 2 years
Placebo
Drug40 mg matching placebo self-administered subcutaneously using a pre-filled syringe (PFS) every 2 weeks for up to 2 years
Change in Parkinson Disease Related Pattern (PDRP) expression
Change from Baseline to Week 96in the expression of the Parkinson Disease Related Pattern (PDRP) assessed by 18-flurodeoxyglucose (FDG) Positron Emission Tomography (PET).
Percentage of participants that experience adverse events
Percentage of participants that experience any adverse event
Percentage of participants with clinical laboratory abnormalities
Percentage of participants with any clinical laboratory abnormalities
Percentage of participants with possible new onset of disease
Percentage of participants with serious infections and/or signs and symptoms suggestive of new onset demyelinating disease
Percentage of participants with new onset of disease
Percentage of participants with new demyelinating lesions on brain MRI scan
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Yale University
Lead sponsor
The Marcus Foundation
Collaborator
National Institute on Aging (NIA)
Collaborator
University of Rochester - Center for Health + Technology (CHeT)/Clinical Trials Coordinaton Center (CTCC)
Collaborator
The Parkinson Study Group
Collaborator
