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NCT04445831 (ACI-35.030 in Preclinical/Presymptomatic Alzheimer's Disease): BVCT ex-ante prediction vs. reported outcome

On 3 Oct 2022, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 24 Jan 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
NCT04445831
Drug Name
ACI-35.030 (JNJ-2056)
Drug MoA
active anti-tau immunotherapy ACI-35.030
Drug Modality
vaccine
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Preclinical/Presymptomatic Alzheimer's Disease
Human Patients
57
Sponsor
AC Immune SA
Phase
Phase 1 Phase 2

Prediction of , index 412

Prospective Prediction
Prediction Index
412
Prediction Date
Commercial Prediction
FAILURE
Technical Prediction
FAILURE

Readout of

Prediction Validation
Readout Date
Prediction To Readout
844 days in advance
Readout Data Interpretation
ACI-35.030's CDR-SB data were never reported; yet the enrolment has been voluntarily paused for the next phase 2b ReTain trial
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
A Phase Ib/IIa Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Immunogenicity of Different Doses, Regimens and Combinations of Tau Targeted Vaccines in Subjects With Early Alzheimer's Disease
Phase
Phase 1, Phase 2
Status
Completed
Enrollment
57
Lead sponsor
AC Immune SA
Conditions
Alzheimer's Disease; Cognitive Impairment; Tauopathies; Mild Cognitive Impairment; Dementia; Brain Diseases; Central Nervous System Diseases
Interventions
BIOLOGICAL: ACI-35.030; BIOLOGICAL: ACI-35.030; BIOLOGICAL: ACI-35.030; OTHER: Placebo; BIOLOGICAL: JACI-35.054; BIOLOGICAL: JACI-35.054
Design
Randomized · Sequential · Quadruple
Primary purpose
Treatment
Start
2019-07-31
Primary completion
2023-09-05
Completion
2023-09-05
Results first posted
2025-02-14
Primary outcomes
  • Overview of Treatment-Emergent Adverse Events, Safety Set (AEs falling between first dosing (week 0) and last study visit (week 74), ie up to 74 weeks, defined as Treatment-Emergent Adverse Events (TEAEs))
  • Overview of Treatment-Emergent Adverse Events Assessed by Intensity, Safety Set (Between the first dosing and the last study visit (week 74))
  • Overview of Treatment-Emergent Adverse Events Assessed by Relationship to Study Drug, Safety Set (Between the first dosing and the last study visit (week 74))
  • Mean Change From Baseline in Diastolic Blood Pressure, ITT Set (Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.)
  • Mean Change From Baseline in Systolic Blood Pressure, ITT Set (Endpoint is assessed from baseline (i.e. last non-missing value prior to the first immunization at week 0) to the last study visit (week 74), at weeks 26, 50 and 74.)

NCT04445831 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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