RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Adalimumab for REM Sleep Behavior Disorder

Q: Is NCT06996652 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT06996652?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT06996652?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

This is a phase 2 study to assess the ability of adalimumab as compared to dummy treatment (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.

Official registry: https://clinicaltrials.gov/study/NCT06996652 · Yale University · enrollment listed as 108

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Adalimumab, or Placebo. The registry lists allocation as randomized. This is a phase 2 study to assess the ability of adalimumab as compared to dummy treatment (placebo) to reduce or prevent progression of synuclein-related neurodegeneration in persons with idiopathic REM Sleep Behavior Disorder (RBD).

They plan to enroll about 108 people at 18 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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)

Interventions: Adalimumab, Placebo

Primary outcome (registry wording): Change in Parkinson Disease Related Pattern (PDRP) expression

Who it is for (from inclusion criteria)

Ages 50 Years to 80 Years
Males, or females who are either
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:
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 Parkinson's Disease or Lewy Body Dementia

Who the registry excludes

Women who are pregnant, planning to become pregnant, or currently breastfeeding
Alternative explanation or etiology for the presence of RBD (e.g. narcolepsy)
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
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

Public study contact (from the registry)

Erika Renkl

475-254-9169

erika.renkl@yale.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

18 listed

Cedars Sinai Medical Center — Los Angeles, California (not_yet_recruiting)
University of Colorado Anschutz — Aurora, Colorado (recruiting)
Yale Medicine — North Haven, Connecticut (recruiting)
Parkinson's Disease & Movement Disorders Center of Boca Raton — Boca Raton, Florida (recruiting)
Emory University School of Medicine — Atlanta, Georgia (not_yet_recruiting)
Johns Hopkins University — Baltimore, Maryland (recruiting)
Massachusetts General Hospital — Boston, Massachusetts (recruiting)
Beth Israel Deaconess Medical Center — Boston, Massachusetts (not_yet_recruiting)
University of Minnesota — Minneapolis, Minnesota (not_yet_recruiting)
Washington University — St Louis, Missouri (recruiting)
Cleveland Clinic Lou Ruvo Center for Brain Health - Las Vegas — Las Vegas, Nevada (not_yet_recruiting)
Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire (not_yet_recruiting)

+ 1 sites outside the US on the same record

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FAQ about this NCT record

Is NCT06996652 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06996652?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06996652?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary