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NCT05712187 (ALTO-100 in Major Depressive Disorder): BVCT ex-ante prediction vs. reported outcome

On 6 Aug 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 22 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
NCT05712187
Drug Name
ALTO-100
Drug MoA
BDNF activator
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Mental Disorders
Indication
Major Depressive Disorder
Human Patients
301
Sponsor
Alto Neuroscience
Phase
Phase 2

Prediction of , index 1718

Prospective Prediction
Prediction Index
1718
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient (additive) clinical benefit in MADRS inferior to lumateperone)
Technical Prediction
FAILURE (statistically maybe significant yet very weak (additive) clinical benefit in MADRS)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
77 days in advance
Readout Data Interpretation
ALTO100 did not meet the primary efficacy endpoint MADRS
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 of ALTO-100 With an Open-Label Extension in Adults With Major Depressive Disorder
Phase
Phase 2
Status
Completed
Enrollment
301
Lead sponsor
Alto Neuroscience
Conditions
Major Depressive Disorder
Interventions
DRUG: ALTO-100; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2023-01-10
Primary completion
2024-09-05
Completion
2024-10-24
Primary outcomes
  • To assess efficacy of ALTO-100 versus placebo on symptoms of MDD in a pre-defined subgroup of participants as measured by the change from Day 1 to Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. (Change assessed from Day 1 to Week 6)

NCT05712187 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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