BioinvestGPT ApS · Research use only

NCT03507790 (CT1812 in Mild to Moderate Alzheimer's Disease): BVCT ex-ante prediction vs. reported outcome

On 18 Mar 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 29 Jul 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

Acronym
SHINE
Drug Name
CT1812
Drug MoA
allosteric sigma-2 receptor antagonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Mild to Moderate Alzheimer's Disease
Human Patients
153
Sponsor
Cognition Therapeutics
Phase
Phase 2

Prediction of , index 1510

Prospective Prediction
Prediction Index
1510
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit inferior to donanemab/lecanemab)
Technical Prediction
partial SUCCESS (statistically maybe significant yet very weak clinical benefit despite tolerable toxicity)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
133 days in advance
Readout Data Interpretation
safe yet none of the key exploratory efficacy endpoints was met (consistent trend only).
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, Parallel-Group, Phase 2 Study to Evaluate the Safety and Efficacy of CT1812 in Subjects With Mild to Moderate Alzheimer's Disease.
Phase
Phase 2
Status
Completed
Enrollment
153
Lead sponsor
Cognition Therapeutics
Conditions
Mild to Moderate Alzheimer's Disease
Interventions
DRUG: CT1812; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2018-10-10
Primary completion
2024-05-29
Completion
2024-05-29
Results first posted
2025-08-11
Primary outcomes
  • Number of Study Participants With at Least One Mild, Moderate, or Severe Treatment Emergent Adverse Events (TEAEs) (Up to 210 Days)
  • Number of Study Participants With at Least One Treatment Emergent Adverse Events (TEAs) and Serious Adverse Events (SAEs). (Up to 210 Days)

NCT03507790 on ClinicalTrials.gov

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