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Exploring Adalimumab for REM Sleep Behavior Disorder

This study is exploring whether a medication called adalimumab can help prevent the progression of brain changes linked to Parkinson's disease in people with REM Sleep Behavior Disorder (RBD). RBD is a condition where you act out your dreams. Participants will receive either adalimumab or a placebo (an inactive substance) through injections every two weeks for up to two years. Researchers will use special brain scans (PET scans) to see if adalimumab can reduce or stop the changes in the brain that are often seen in Parkinson's disease. The study is looking for 108 participants between 50 and 80 years old. The current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It involves 108 participants who will be randomly assigned to receive either adalimumab or a placebo.
What's involved
Participants will self-administer injections every two weeks for up to two years. They will also have brain scans at the beginning and after 96 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for changes in brain activity up to 96 weeks (about 2 years).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06996652

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)

Recruiting
PHASE2Ages 50–80InterventionalPrevention
Yale University
~108 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:AdalimumabPlacebo

At a glance

Recruiting sites
2 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Parkinson Disease Related Pattern (PDRP) expression
Measured over Baseline and Week 96

Conditions

REM Sleep Behavior Disorder

Explore related trials

Parkinson Disease Related PatternREM sleep behavior disorder

NCT06996652

Where you'd take part

This study runs at 19 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Beth Israel Deaconess Medical Center

    Boston, Massachusettsstudy coordinator listed

    Not yet recruiting

  • Cedars Sinai Medical Center

    Los Angeles, Californiastudy coordinator listed

    Not yet recruiting

  • Cleveland Clinic Lou Ruvo Center for Brain Health - Las Vegas

    Las Vegas, Nevadastudy coordinator listed

    Not yet recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshirestudy coordinator listed

    Not yet recruiting

  • Emory University School of Medicine

    Atlanta, Georgiastudy coordinator listed

    Not yet recruiting

  • Johns Hopkins University

    Baltimore, Marylandstudy coordinator listed

    Not yet recruiting

  • Massachusetts General Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolinastudy coordinator listed

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jesse Cedarbaum, MD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Erika Renkl
[email protected]
475-254-9169
Email the study team

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Eligibility criteria

Inclusion

Males, or females who are either
Diagnosis of idiopathic REM Sleep Behavior Disorder (RBD) based upon:
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

Exclusion

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
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:
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 Screening 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.
Any of the following laboratory abnormalities at Screening
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 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))
Taking any of the following medications:
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 interventional 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

What this trial measures

  • Change in Parkinson Disease Related Pattern (PDRP) expressionBaseline and Week 96

    Change from Baseline to Week 96in the expression of the Parkinson Disease Related Pattern (PDRP) assessed by 18-flurodeoxyglucose (FDG) Positron Emission Tomography (PET).