A Study to Evaluate the Effects of ACI-7104.056 Vaccination in Patients With Early Stages of Parkinson's Disease — VacSYn  

Parkinson Disease Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability, immunogenicity, and pharmacodynamic effects of ACI-7104.056 vaccination in patients with early stages of Parkinson's disease.

Clinical Trial Description

This is a prospective, multicenter, placebo-controlled, double-blind, randomized study with adaptive features, comprising a screening period of up to 8 weeks, a 74-week double-blind treatment period, and a 26-week post-treatment follow-up period.

Up to 3 cohorts will include 16 subjects each (12 under the study vaccine and 4 under placebo; 3:1 active treatment/placebo ratio). One of the initial potential 3 cohorts (Cohorts 2 and 3 are optional) may be expanded in order to reach an overall total of up to 150 subjects in the study. In case a cohort is expanded, the randomization ratio will be adjusted to achieve an active treatment/placebo ratio of 2:1 in this cohort.

The route of administration of the study vaccine and placebo will be by intramuscular injections. ;

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson Disease 6, Early-Onset

• NCT number: NCT06015841
• Study type: Interventional
• Source: AC Immune SA
• Contact: Olivier Sol
• Phone: +41 21 345 91 21
• Email: clinicaltrials@acimmune.com
• Status: Recruiting
• Phase: Phase 2
• Start date: July 24, 2023
• Completion date: January 2028