Testing Adalimumab against a placebo for REM sleep behavior disorder

Exclusion

• −History of an allergic reaction or significant sensitivity to adalimumab or constituents of the study drug (and its excipients) and/or other products in the same class
• −Current or previous hepatitis B infection (defined as positive test for hepatitis B surface antigen (HbSAg) and/or hepatitis B core antibody (anti-HBc).
• −Participants with immunity to hepatitis B (if due to natural infection defined as negative HBsAg, positive hepatitis B antibody (anti-HBs) and positive anti-HBc; if due to vaccination defined as negative HBsAg, negative anti-HBc and positive anti-HBs are eligible to participate in the study
• −For patients with resolved HBV infection, if anti-HBc negative, HBV DNA testing is needed prior to initiating study drug j. History or positive test at ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more → for hepatitis C virus antibody (anti-HCV) in the absence of treatment resulting in cure k. History or positive test at Screening for human immunodeficiency virus (HIV) l. History of untreated or incompletely treated tuberculosis or a positive tuberculosis IGRA test.
• −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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, 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
• −Any contra-indication to undergo MRI, as judged by local PI or radiologist, including but not limited to presence of pacemaker, aneurysm clips, artificial heart valves, ear implants, ventriculoperitoneal shunt, foreign metal objects in the eyes, skin or body or any other circumstance which would contra-indicate an MRI scan or impair MRI image quality, or history of claustrophobia or of not tolerating MRI scanning procedures
• −History or active presence of any of the following neurological, psychiatric or medical conditions:
• −Large vessel stroke
• −Peripheral or CNS demyelinating disease
• −Chronic and/or recurrent fungal, bacterial or opportunistic infections
• −Myocardial infarction or unstable angina within the previous 12 months
• −Clinically relevant or significant ECG abnormalities, including ECG with QT interval corrected for heart rate using Fridericia's formula (QT interval corrected for heart rate using Fridericia's formula) \> 450 msec (males) or \> 470 msec (females).
• −Congestive heart failure, NYHA Class 3 or 4
• −Autoimmune disease (e.g., Systemic Lupus Erythematosis (SLE), or symptoms suggestive of a lupus-like syndrome, multiple sclerosis, rheumatoid arthritis, Type 1 diabetes mellitus, inflammatory bowel disease, psoriasis, etc.)
• −Immunocompromised systemically due to continuing effects of immune suppressing medication
• −Any of the following laboratory abnormalities at Screening
• −Screening values for hemoglobin \< 12 g/d for men or \< 11 g/dL for women or other clinically significant hematological abnormality
• −Any serum chemistry value (e.g., AST, ALT, alkaline phosphatase, CK, total bilirubin etc. \> 2x the upper limit of normal on 2 successive determinations less than 2 weeks apart
• −Serum creatinine above the ULN or eGFR \< 60 mL/min/1.73 m2
• −Platelet count, INR, PT or PTT not within the normal range or other risk for increased or uncontrolled bleeding
• −Any other significant medical conditions that, in the opinion of the investigator, would prohibit participation in the study, including inability to tolerate the MRI scan
• −Taking any of the following medications:
• −Symptomatic anti-Parkinson agents, including but not limited to levodopa-containing preparations, dopamine agonists, monoamine oxidase inhibitors, amantadine, and adenosine receptor antagonists taken any time prior to the screening visit
• −Cognitive enhancing agents, including but not limited to acetylcholinesterase inhibitors and memantine taken any time prior to the screening visit
• −Stimulant medications, including but not limited to lisdexamphetamine, dextroamphetamine/amphetamine (Adderall) and methylphenidate taken at any time prior to the screening visit
• −Antipsychotic agents, including pimavanserin
• −Antidepressant medications whose dose has not been stable for at least 90 days
• −Use of any of the following medications within 12 months prior to Screening: Immunosuppressant medications, including chronic corticosteroids, anakinra and abatacept
• −Any previous use of injected or infused antibody therapies, including but not limited antibodies directed against TNF, anti-IL-6, natalizumab, rituximab, conventional or targeted DMARD agents
• −For participants agreeing to undergo lumbar puncture: Anticoagulant or anti-platelet medications including warfarin, heparinoids and direct coagulation factor inhibitors (e.g., apixaban, dabigatran, rivaroxaban) within 90 days of the planned first dose of study drug; either aspirin at a dose of \<¬ 100 mg/day or clopidogrel at a dose of 75 mg/day, but use of both in combination is permitted.
• −Received any live vaccine, with the exception of non-replicating live viral vaccines such as Jynneos vaccine, within 30 days prior to the first dose of study drug, or expected need of live vaccination during study participation including at least 70 days after the last dose of study drug.
• −Participation in any other interventionalInterventional studyA study where participants are given something to see what happens.Read more → clinical trial, or treatment with any investigational drug or investigational use of an approved therapy within 30 days (or 5 half-lives of such agent) prior to the first Screening visit.
• −History of drug or alcohol abuse within the last 5 years (including cannabis use disorder)
• −Positive urine drug test at screening
• −Unwillingness or inability to comply with study requirements, including self-administration of study medication, or history of noncompliance in prior clinical trials
• −Women who are pregnant, planning to become pregnant, or currently breastfeeding
• −m. History of malignancy other than successfully treated, non-metastatic cutaneous squamous or basal cell carcinoma or localized carcinoma in situ of the cervix n. Major depressive episode requiring initiation of medication or hospitalization within the previous 90 days o. Seated blood pressure \> 150/90 on 3 separate determinations p. Presence of hallucinations or delusions q. Psychiatric disorder (schizophrenia, schizoaffective disorder, etc.) associated with psychosis r. Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral/intramuscular anti-infectives within 14 days prior to baselineBaselineYour starting measurements, taken before treatment begins.Read more → s. Major surgery within 12 weeks of screening t. Blood donation of 1 unit or more within 8 weeks prior to the first dose of study medication
• −For participants agreeing to lumbar puncture: Presence of contra-indication to lumbar puncture as judged by local PI (e.g., known X-ray or other evidence of significant lumbar spine abnormalities or history of lumbar surgery with sequalae that would interfere with or pose risks from the procedure; platelet count below 50,000 cells/mL; need for anticoagulant or antiplatelet medications other than aspirin at a dose of \< 100 mg/day or clopidogrel (see item 10 (g) below))