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New treatment option for REM Sleep Behavior Disorder
Official title 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)
ClinicalTrials.gov ID: NCT06996652
What this study is testing
What is Adalimumab?
Adalimumab is an investigational medicine, given as a monthly injection under the skin, being studied as a potential treatment for rem sleep behavior disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 80
You may be able to join if
- 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...
- practicing adequate contraception. Female participants of childbearing potential must practice at least 1 protocol-specified method of birth control...
- Diagnosis of idiopathic REM sleep behavior disorder Diagnosis of idiopathic REM Sleep Behavior Disorder (RBD) based upon:
- History of Dream Enactment Behavior during sleep and
You likely can't join if
- 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...
- As assessed by the central reader, MRI evidence of (a) more than three lacunar infarcts, (b) territorial infarct or macroscopic hemorrhage, or (c)...
- Any contra-indication to undergo MRI, as judged by local PI or radiologist, including but not limited to presence of pacemaker, aneurysm clips...
- History or active presence of any of the following neurological, psychiatric or medical conditions:
- Large vessel stroke
See the full eligibility criteria
Who can join
- 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...
- 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...
- Diagnosis of idiopathic REM sleep behavior disorder 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 parkinsonism 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
What rules you out
- 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...
- 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...
- 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...
- 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...
- Immunocompromised systemically due to continuing effects of immune suppressing medication
- 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...
- History or positive test at Screening for hepatitis C virus antibody (anti-HCV) in the absence of treatment resulting in cure
- History or positive test at Screening for human immunodeficiency virus (HIV)
- History of untreated or incompletely treated tuberculosis or a positive tuberculosis IGRA test.
- History of malignancy other than successfully treated, non-metastatic cutaneous squamous or basal cell carcinoma or localized carcinoma in situ of the cervix
- Major depressive episode requiring initiation of medication or hospitalization within the previous 90 days
- Seated blood pressure \> 150/90 on 3 separate determinations
- Presence of hallucinations or delusions
- Psychiatric disorder (schizophrenia, schizoaffective disorder, etc.) associated with psychosis
- Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral/intramuscular anti-infectives within 14 days prior to baseline
- Major surgery within 12 weeks of screening
- Blood donation of 1 unit or more within 8 weeks prior to the first dose of study 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
- 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...
- 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...
- 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...
- 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...
- 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
- Participation in any other treatment 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Aurora, Colorado, United States
- North Haven, Connecticut, United States
- Boca Raton, Florida, United States
- Atlanta, Georgia, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
- St Louis, Missouri, United States
- Las Vegas, Nevada, United States
- Lebanon, New Hampshire, United States
- New York, New York, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Charleston, South Carolina, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Aurora, Colorado, United States; North Haven, Connecticut, United States; Boca Raton, Florida, United States; Atlanta, Georgia, United States; Baltimore, Maryland, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.