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NCT05619692 (SAGE-718 in Alzheimer's Disease): BVCT ex-ante prediction vs. reported outcome

On 20 Apr 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 8 Oct 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
NCT05619692
Acronym
LIGHTWAVE
Drug Name
SAGE-718 (dalzanemdor)
Drug MoA
NMDAR PAM
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Alzheimer's Disease
Human Patients
174
Sponsor
Sage Therapeutics
Phase
Phase 2

Prediction of , index 1382

Prospective Prediction
Prediction Index
1382
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
FAILURE (statistically insignificant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
171 days in advance
Readout Data Interpretation
dalzanemdor failed to meet the primary efficacy endpoint.
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 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of SAGE-718 in Participants With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease
Phase
Phase 2
Status
Completed
Enrollment
174
Lead sponsor
Supernus Pharmaceuticals, Inc.
Conditions
Mild Cognitive Impairment; Mild Dementia; Alzheimer's Disease
Interventions
DRUG: SAGE-718; DRUG: SAGE-718-matching Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-11-29
Primary completion
2024-06-05
Completion
2024-07-09
Results first posted
2025-06-18
Primary outcomes
  • Change From Baseline in the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding Test Score (Baseline, Day 84)

NCT05619692 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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