ACI-7104-PD-2103
Research type
Research Study
Full 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
IRAS ID
1006102
Contact name
Julien Rongere
Contact email
Sponsor organisation
AC Immune SA
Eudract number
2022-500292-31
Research summary
The purpose of this research study is to assess the safety and tolerability of a vaccine called ACI-7104.056 and the antibody response induced by the study vaccine in patients with early Parkinson’s Disease aged 40-75 year-old. Neurodegenerative diseases such as Parkinson’s Disease are characterised by chronic disease progression leading to disability. Currently there are no treatments that are able to prevent, stop or slow this progression.
This vaccine have been designed to induce antibodies that selectively reduce proteins in the body called pathological a-syn aggregates which are accumulated in neurodegenerative disorders like Parkinson’s Disease and are thought to drive the development and progression of the disease. The hope is that the vaccine will enable some control over the formation of a-syn aggregates thereby slowing the progression of the disease.
The study will have up to 3 cohorts, groups of 16 participants in each cohort, who will receive either the study vaccine or placebo.
Participants will complete the study over a total period of approx. 2 years. During this period participants will receive the study vaccine or placebo for around 18 months (74 weeks) following by monitoring by the study doctor for around 6 months (26 weeks).REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
22/YH/0258
Date of REC Opinion
14 Feb 2023
REC opinion
Further Information Favourable Opinion