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NCT04994483 (Simufilam in Alzheimer's Disease): BVCT ex-ante prediction vs. reported outcome

On 6 Aug 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 25 Nov 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
NCT04994483
Acronym
RETHINK-ALZ
Drug Name
Simufilam
Drug MoA
misfolded FLNA inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Alzheimer's Disease
Human Patients
804
Sponsor
Cassava Sciences
Phase
Phase 3

Prediction of , index 1724

Prospective Prediction
Prediction Index
1724
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in ADAS-COG12/ADCS-ADL23 inferior to lecanemab)
Technical Prediction
FAILURE (statistically maybe significant yet very weak clinical benefit in ADAS-COG12/ADCS-ADL23 against placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
111 days in advance
Readout Data Interpretation
simufilam failed to meet primary efficacy endpoints ADAS-COG12 and ADCS-ADL at week 52
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 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Study Evaluating the Safety and Efficacy of Simufilam 100 mg Tablets in Subjects With Mild-to-Moderate Alzheimer's Disease
Phase
Phase 3
Status
Completed
Enrollment
804
Lead sponsor
Cassava Sciences, Inc.
Conditions
Alzheimer Disease
Interventions
DRUG: Simufilam; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2021-11-03
Primary completion
2024-10-02
Completion
2024-10-02
Results first posted
2025-05-25
Primary outcomes
  • Change From Baseline in the 12-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) (Baseline (Study Day 1) to Week 52)
  • Change From Baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) (Baseline (Study Day 1) to Week 52)

NCT04994483 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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