This is a multi-center, randomized, double blind, adaptive, parallel-group, placebo controlled Phase 1b study to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamics of RO7486967 in participants with idiopathic PD at the early stage of the disease (modified H\&Y stage ≤2.5) who are either treatment-naïve or on stable treatment with symptomatic therapy (levodopa and/or pramipexole, ropinirole, rotigotine).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
University of Alabama at Birmingham
Birmingham, Alabama, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Percentage of Participants with adverse events (AEs)
Time frame: Up to 45 Days
The change in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores from baseline
Time frame: From Baseline to Up to 45 Days
Time to maximum concentration of RO7486967 in Plasma
Time frame: Day 1, Day 15, and Day 28
Maximum concentration (Cmax) of RO7486967 in Plasma
Time frame: Day 1, Day 15, and Day 28
Area under the curve (AUC) RO7486967 in Plasma
Time frame: Day 1, Day 15, and Day 28
Change from baseline in parametric bindings of [18F]-DPA-714 in different brain areas at Day 25 PET
Time frame: From Baseline to Approximately Day 25
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CenExel Rocky Mountain Clinical Research, LLC
Englewood, Colorado, United States
Georgetown University
Washington D.C., District of Columbia, United States
Advent Health Orlando
Orlando, Florida, United States
Quest Research Institute
Farmington Hills, Michigan, United States
Weill Cornell Medical College
New York, New York, United States
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, United States
University Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Brain Research Center B.V
Amsterdam, Netherlands
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