An Exploratory Study of the Potential for Rational Immune System Manipulation to Prevent Emergenc… (NCT06996652) | Clinical Trial Compass
Not Yet RecruitingPhase 2
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)
United States108 participantsStarted 2026-05
Plain-language summary
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.
Who can participate
Age range50 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✓. practicing adequate contraception. Female subjects 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 subjects of non-childbearing potential do not need to use birth control.
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Change in Parkinson Disease Related Pattern (PDRP) expression