Phase 2Active, not recruiting
A Study to Evaluate the Effects of ACI-7104.056 in Patients With Early Stages of Parkinson's Disease (VacSYn)
An Adaptive, Phase 2, Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacodynamic Effects of ACI-7104.056 in Patients With Early Stages of Parkinson's Disease
- Sponsor
- AC Immune SA (Industry)
- Enrolment
- 150 planned
- Conditions
- Parkinson Disease; Parkinson Disease 6, Early-Onset
- Interventions
- Placebo; ACI-7104.056 at Dose A; ACI-7104.056 at Dose B (optional); ACI-7104.056 at Dose C (optional)
- Ages
- adults, older adults
- Registry
- NCT06015841
From the registry
The purpose of this study is to evaluate the safety, tolerability, immunogenicity, and pharmacodynamic effects of ACI-7104.056 in patients with early stages of Parkinson's disease.
Primary outcomes
- Number of participants with Adverse Events (AEs) assessed by intensity (mild, moderate or severe) and causal relationship (unrelated, or unlikely, possibly, probably or definitely related)
- Number of participants with abnormal MRI results
- Number of participants with clinically significant changes in physical and neurological examination results
- Number of participants reporting suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS)