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Can a common arthritis drug stop Parkinson's before it starts?

NCT ID NCT06996652

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 10 times

Summary

This study tests whether adalimumab, an anti-inflammatory drug, can prevent brain changes linked to Parkinson's disease in 108 people with REM sleep behavior disorder (RBD). RBD often precedes Parkinson's. Participants will receive adalimumab or a placebo every two weeks for two years, and researchers will monitor brain activity using PET scans.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Adalimumab (a drug that reduces inflammation, given as a shot every 2 weeks)
What this could lead to
If it works, this could point toward a way to delay or prevent Parkinson's disease in people with REM sleep behavior disorder.
What could go wrong
This is an early phase 2 study with only 108 people. It tests a brain scan change, not whether symptoms actually improve. Adalimumab can increase infection risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 108 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Males, or females who are either 1. 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 2. 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. 3. 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: 1. History of Dream Enactment Behavior during sleep and 2. 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 Exclusion Criteria: * 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: 1. Large vessel stroke 2. Peripheral or CNS demyelinating disease 3. Chronic and/or recurrent fungal, bacterial or opportunistic infections 4. Myocardial infarction or unstable angina within the previous 12 months 5. 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). 6. Congestive heart failure, NYHA Class 3 or 4 7. 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.) 8. Immunocompromised systemically due to continuing effects of immune suppressing medication 9. 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 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. 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 baseline 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 * Any of the following laboratory abnormalities at Screening 1. Screening values for hemoglobin \< 12 g/d for men or \< 11 g/dL for women or other clinically significant hematological abnormality 2. 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 3. Serum creatinine above the ULN or eGFR \< 60 mL/min/1.73 m2 4. 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 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: 1. 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 2. Cognitive enhancing agents, including but not limited to acetylcholinesterase inhibitors and memantine taken any time prior to the screening visit 3. Stimulant medications, including but not limited to lisdexamphetamine, dextroamphetamine/amphetamine (Adderall) and methylphenidate taken at any time prior to the screening visit 4. Antipsychotic agents, including pimavanserin 5. Antidepressant medications whose dose has not been stable for at least 90 days 6. Use of any of the following medications within 12 months prior to Screening: Immunosuppressant medications, including chronic corticosteroids, anakinra and abatacept 7. 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 8. 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. 9. 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. * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    19 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02215, United States

  • Cedars Sinai Medical Center

    NOT_YET_RECRUITING

    Los Angeles, California, 90048, United States

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

    NOT_YET_RECRUITING

    Las Vegas, Nevada, 89106, United States

  • Dartmouth Hitchcock Medical Center

    NOT_YET_RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Emory University School of Medicine

    NOT_YET_RECRUITING

    Atlanta, Georgia, 30329, United States

  • Johns Hopkins University

    NOT_YET_RECRUITING

    Baltimore, Maryland, 21287, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Medical University of South Carolina

    NOT_YET_RECRUITING

    Charleston, South Carolina, 29403, United States

  • Montreal Neurological Institute-Hospital at McGill University

    NOT_YET_RECRUITING

    Montreal, Quebec, H3A 2B4, Canada

  • Oregon Health & Science University

    NOT_YET_RECRUITING

    Portland, Oregon, 97239, United States

    Contact Email: •••••@•••••

  • Parkinson's Disease & Movement Disorders Center of Boca Raton

    NOT_YET_RECRUITING

    Boca Raton, Florida, 33486, United States

  • University of Colorado Anschutz

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Minnesota

    NOT_YET_RECRUITING

    Minneapolis, Minnesota, 55414, United States

  • University of Pennsylvania

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • University of Texas Health Science Center- San Antonio

    NOT_YET_RECRUITING

    San Antonio, Texas, 78229, United States

  • University of Texas Houston Medical Center

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Washington University

    NOT_YET_RECRUITING

    St Louis, Missouri, 63110, United States

  • Weill Medical College of Cornell University

    NOT_YET_RECRUITING

    New York, New York, 10021, United States

  • Yale Medicine

    NOT_YET_RECRUITING

    North Haven, Connecticut, 06473, United States

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