A Study to Investigate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7486967 in Participants With Early Idiopathic Parkinson's Disease.
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Lead
Hoffmann-La Roche
Age
40–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
Clareo Health | A Study to Investigate The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7486967 in Participants With Early Idiopathic Parkinson's Disease.