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

Phase 2

Recruiting

• Conditions: Parkinson Disease; Parkinson Disease 6, Early-Onset

• Registration Number: NCT06015841
• Lead Sponsor: AC Immune SA

Brief 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.

Detailed 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 Timeline

• Study Start: 2023-07-24
• Study First Submitted: 2023-08-04
• Study First Submitted QC: 2023-08-22
• Study First Posted: 2023-08-29
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-01
• Primary Completion: 2028-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
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)	From Screening (ICF signature) to Week 100
Number of participants with abnormal MRI results	From Baseline to Week 100
Measurement of levels of specific antibodies against a-synuclein present in serum generated by ACI-7104.056	From Baseline to Week 100
Number of participants with clinically significant changes in physical and neurological examination results	From Baseline to Week 74
Number of participants reporting suicidal ideation or behavior using Columbia-Suicide Severity Rating Scale (C-SSRS)	From Baseline to Week 100

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III	From Baseline to Week 100
Measures of alpha-synuclein (a-syn) related biofluid biomarkers	From Baseline to Week 100
Measurement of levels of dopamine transporter proteins in specific brain regions, notably substantia nigra, by Dopamine Transporter-Single Photon Emission Computerized Tomography (DaT-SPECT) imaging	From Baseline to Week 100

Trial Locations

Locations (12)

Katholisches Klinikum Bochum GmbH; 🇩🇪 Bochum, Germany

Paracelsus-Kliniken Deutschland GmbH & Co. KGaA; 🇩🇪 Kassel, Germany

University Medical Centre Schleswig-Holstein; 🇩🇪 Kiel, Germany

Hospital De La Santa Creu I Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Universitari Vall D Hebron; 🇪🇸 Barcelona, Spain

Policlinica Gipuzkoa; 🇪🇸 Donostia, Spain

Hospital Universitario De La Princesa; 🇪🇸 Madrid, Spain

Hospital Universitario Puerta De Hierro De Majadahonda; 🇪🇸 Majadahonda, Spain

Hospital Universitario Quironsalud Madrid; 🇪🇸 Pozuelo De Alarcón, Spain

King's College Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom

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