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NCT04498650 (PQ912 in Early Alzheimer's Disease Mild Cognitive Impairment…): BVCT ex-ante prediction vs. reported outcome

On 20 Jan 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 4 Mar 2024 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
NCT04498650
Acronym
VIVIAD
Drug Name
PQ912
Drug MoA
QPCT/QPCTL inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Early Alzheimer's Disease Mild Cognitive Impairment Due to AD
Human Patients
259
Sponsor
Vivoryon Therapeutics
Phase
Phase 2

Prediction of , index 1431

Prospective Prediction
Prediction Index
1431
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit inferior to donanemab or lecanemab)
Technical Prediction
partial SUCCESS (statistically maybe significant yet very weak clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
44 days in advance
Readout Data Interpretation
primary/secondary endpoint not met.
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 2b Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Dose Finding, Safety, Tolerability and Efficacy Study of PQ912 in Subjects With MCI and Mild Dementia Due to Alzheimer's Disease.
Phase
Phase 2
Status
Completed
Enrollment
259
Lead sponsor
Vivoryon Therapeutics N.V.
Conditions
Early Alzheimers Disease; Mild Cognitive Impairment Due to AD
Interventions
DRUG: PQ912; DRUG: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2020-07-06
Primary completion
2023-12-18
Completion
2024-01-12
Primary outcomes
  • Primary safety: The proportion of participants who experience any Adverse Event (AE), Serious Adverse Event (SAE), Adverse Event of Interest (AE-I) (48 weeks)
  • Primary efficacy: within-participant linear change with time of the combinded z-score for cognition compared between active arm and placebo. (48 weeks and EoT (96 weeks at maximum))

NCT04498650 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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