BioinvestGPT

BioinvestGPT ApS · Research use only

NCT04777396 (Semaglutide in Early-Stage Symptomatic Alzheimer's Disease): BVCT ex-ante prediction vs. reported outcome

On 24 Mar 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 24 Nov 2025 readout is classified on the dashboard as False Positive (FP), a missed prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT04777396
Acronym
EVOKE
Drug Name
Semaglutide
Drug MoA
GLP-1 receptor agonist Oral
Drug Modality
peptide
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Early-Stage Symptomatic Alzheimer's Disease
Human Patients
1840
Sponsor
Novo Nordisk
Phase
Phase 3

Prediction of , index 1520

Prospective Prediction
Prediction Index
1520
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit with superior-todonamemab/lecanemab efficacy in CDR-SB and ADCS-ADL-MCI)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
610 days in advance
Readout Data Interpretation
oral semaglutide in early AD did not demonstrate statistically significant reduction in disease progression on CDR-SB
Press Release
Prediction Result
Prediction Accuracy
Missed Prediction
Due to
due to suboptimal causal modeling of GLP1RA in the exact clinical setting of early AD that has been permanently improved
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
False Positive (FP)

ClinicalTrials.gov record

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

Official title
A Randomised Double-blind Placebo-controlled Clinical Trial Investigating the Effect and Safety of Oral Semaglutide in Subjects With Early Alzheimer´s Disease (EVOKE)
Phase
Phase 3
Status
Completed
Enrollment
1840
Lead sponsor
Novo Nordisk A/S
Conditions
Early Alzheimer's Disease
Interventions
DRUG: Semagludtide; DRUG: Placebo (semaglutide)
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2021-05-18
Primary completion
2025-09-16
Completion
2026-01-30
Primary outcomes
  • Change in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) score (From baseline (week 0) to week 104)

NCT04777396 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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