A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)
Denali Therapeutics Inc.
Summary
This Phase 2a, multicenter, randomized, 12-week double-blind, placebo-controlled, parallel-group study, followed by an OLE, is designed to evaluate the safety, tolerability, and pharmacodynamic effects of BIIB122 in participants with LRRK2-PD. LRRK2-PD is defined as Parkinson's Disease (PD) in individuals who are heterozygous or homozygous carriers of a pathogenic LRRK2 variant that increases LRRK2 kinase activity.
Eligibility
- Age range
- 30+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * For heterozygous pathogenic LRRK2 mutation carriers: ≥ 30 to ≤ 80 years * For homozygous pathogenic LRRK2 mutation carriers: ≥ 30 years * Have screening genetic test results verifying the presence of a pathogenic LRRK2 variant. * Have a clinical diagnosis of PD meeting the Movement Disorder Society Clinical Diagnostic Criteria. Exclusion Criteria: * Have a history of any clinically significant neurological disorder other than PD, including, but not limited to, stroke and dementia, in the opinion of the investigator, within 5 years of the screening visit. * Have clinica…
Interventions
- DrugBIIB122 225 mg
Administered as specified in the treatment arm
- OtherBIIB122-Matching Placebo
Administered as specified in the treatment arm
Locations (20)
- Cedars-Sinai Department of NeurologyLos Angeles, California
- University of California San FranciscoSan Francisco, California
- Parkinson's Disease and Movement Disorders CenterBoca Raton, Florida
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Ichan School of Medicine at Mount Sinai/Beth Israel Downtown-Movement Disorder CenterNew York, New York
- Evergreen Health LaboratoryKirkland, Washington