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 Phase 2 Interventional Study
REM Sleep Behavior Disorder
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
50 – 80
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
108 (estimated)
Sponsor
Yale University · Other
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About This Trial
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 Em…
Trial Locations
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Eligibility Criteria
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, bilater…
Contacts

Erika Renkl

475-254-9169

erika.renkl@yale.edu

CONTACT