NCT06015841Phase 2Active not recruiting

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

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2028-01Estimated

Enrollment · participants150Estimated

Source updated2025-11-21Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2025-11-21 · 1 field changed

Recruitment status

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Recruiting

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Active not recruiting

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Study details

Conditions studied

Parkinson Disease; Parkinson Disease 6, Early-Onset

Treatments or interventions studied

PlaceboBiological
ACI-7104.056 at Dose ABiological
ACI-7104.056 at Dose B (optional)Biological
ACI-7104.056 at Dose C (optional)Biological

Primary outcomes · main study measures

Read the study measures

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

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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