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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. ;


Study Design


Related Conditions & MeSH terms


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

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