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NCT06015841 (adjuvant in Parkinson's Disease): BVCT ex-ante prediction vs. reported outcome

On 7 Jul 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 11 Dec 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT06015841
Acronym
VacSYn
Drug Name
adjuvant
Drug MoA
anti-alpha-synuclein ACI-7104.056 with KLH-Alum
Drug Modality
vaccine
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Parkinson's Disease
Human Patients
150
Sponsor
AC Immune
Phase
Phase 2

Prediction of , index 1665

Prospective Prediction
Prediction Index
1665
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in MDS-UPDRS)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak clinical benefit in lowering brain alpha-synuclein level)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
522 days in advance
Readout Data Interpretation
ACI-7104.056 failed to achieve statistically significant clinical benefit in Total MDS-UPDRS Part III score compared with placebo (trend only)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

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
Phase
Phase 2
Status
Active not recruiting
Enrollment
150
Lead sponsor
AC Immune SA
Conditions
Parkinson Disease; Parkinson Disease 6, Early-Onset
Interventions
BIOLOGICAL: Placebo; BIOLOGICAL: ACI-7104.056 at Dose A; BIOLOGICAL: ACI-7104.056 at Dose B (optional); BIOLOGICAL: ACI-7104.056 at Dose C (optional)
Design
Randomized · Sequential · Quadruple
Primary purpose
Treatment
Start
2023-07-24
Primary completion
2028-01
Completion
2028-01
Primary outcomes
  • 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)
  • 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)
  • Measurement of levels of specific antibodies against a-synuclein present in serum generated by ACI-7104.056 (From Baseline to Week 100)

NCT06015841 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials