Phase
Condition
N/ATreatment
RO7486967
Placebo
Clinical Study ID
Ages 40-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Key Criteria:
Male or post-menopausal female
Diagnosis of clinically probable idiopathic PD based on MDS criteria with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity)
A time from diagnosis of PD of at least 3 to maximum 60 months (5 years) at screening
Modified H&Y Stage ≤2.5 (in ON state)
Dopaminergic imaging consistent with dopamine transporter deficit
"High-affinity binder" or "mixed-affinity binder" genotype for TSPO
Either treatment naïve or treatment with symptomatic PD therapy (levodopa and/or pramipexole, ropinirole, rotigotine) given for at least 90 days, with stable doses for at least 30 days prior to the first dose
No anticipated changes in PD therapy throughout the study duration
SARS-CoV-2 vaccination completed at least 60 days prior to the first dose.
Exclusion Key Criteria:
Medical history indicating a Parkinsonian syndrome other than idiopathic PD
CNS or psychiatric disorders other than idiopathic PD (mild depression or anxiety arising in the context of PD is not exclusionary)
History of brain surgery for PD
Use of any of symptomatic drug for PD other than levodopa pramipexole, ropinirole, or rotigotine within 60 days prior to the first dose
Known carriers for mutations in the following genes: alpha-synuclein, LRRK2, GBA, PRKN, PINK1, or DJ1
Unstable or clinically significant cardiovascular disease within the last year prior to screening
Uncontrolled hypertension
Use of oral anticoagulants, low-molecular-weight heparin, warfarin (Coumadin), acenocoumarol, and phenprocoumon is not allowed within 10 days before the first Lumbar Puncture and during the study (low dose aspirin is permitted as monotherapy)
Concomitant disease or unstable medical condition within 6 months of screening that could interfere with the study or treatment that might interfere with the conduct of the study, including but not limited to autoimmune disease, immunodeficiency diseases, any active infectious disease
History of immunodeficiency diseases
Presence of hepatitis B surface antigen (HBsAg) or positive for total hepatitis B core antibody (HBcAb), or positive hepatitis C (HCV) at screening
Vaccine(s) other than SARS-CoV2 vaccine within 28 days prior to the first dose, or plans to receive vaccines during the study or within 28 days of the last dose
History of chronic liver disease
Clinically significant abnormalities in laboratory test results at screening, including hepatic and renal panels, complete blood count, chemistry panel and urinalysis
Any previous administration of RO7486967 or other compound targeting NLRP3
Enrollment in another investigational study
Use of any of other investigational therapy (other than protocol-mandated study treatment) within 90 days or 5 drug elimination half-lives (whichever is longer) prior to the first dose
Study Design
Connect with a study center
Brain Research Center B.V
Amsterdam, 1081 GN
NetherlandsSite Not Available
UMC St Radboud
Nijmegen, 6525 GA
NetherlandsSite Not Available
Brain Research Center Zwolle
Zwolle, 8025AZ
NetherlandsSite Not Available
University of Exeter
Exeter, EX4 4RN
United KingdomSite Not Available
Barts Health NHS Trust
London, E1 2ES
United KingdomSite Not Available
Imperial College Healthcare NHS Trust; Charing Cross Hospital
London, W6 8RF
United KingdomSite Not Available
National Hospital for Neurology and Neurosurgery; Leonard Wolfson Experimental Neurology Centre CRF
London, WC1N 3BG
United KingdomSite Not Available
St Georges University Hospitals NHS Foundation Trust
London, SW17 0RE
United KingdomSite Not Available
Campus for Ageing & Vitality; Clincal Ageing Research Unit
Newcastle, NE4 5PL
United KingdomSite Not Available
Derriford Hospital
Plymouth, PL6 8BT
United KingdomSite Not Available
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesSite Not Available
Cedars Sinai Medical Center
Los Angeles, California 90048
United StatesSite Not Available
CenExel Rocky Mountain Clinical Research, LLC
Englewood, Colorado 80113
United StatesSite Not Available
Georgetown University
Washington, District of Columbia 20007
United StatesSite Not Available
Advent Health Orlando
Orlando, Florida 32804
United StatesSite Not Available
NeuroStudies.net, LLC
Decatur, Georgia 30033
United StatesSite Not Available
Quest Research Institute
Farmington Hills, Michigan 48334
United StatesSite Not Available
Columbia University Medical Center; The Neurological Institute of New York
New York, New York 10032
United StatesSite Not Available
Weill Cornell Medical College
New York, New York 10065
United StatesSite Not Available
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma 74136
United StatesSite Not Available
University Pennsylvania Hospital
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37212
United StatesSite Not Available
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