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NCT05557409 (AXS-05 in Alzheimer's Disease Agitation): BVCT ex-ante prediction vs. reported outcome

On 6 Jul 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 30 Dec 2024 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
NCT05557409
Acronym
ADVANCE-2
Drug Name
AXS-05
Drug MoA
NMDAR antagonist & sigma-1 receptor agonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Alzheimer's Disease Agitation
Human Patients
350
Sponsor
Axsome Therapeutics
Phase
Phase 3

Prediction of , index 898

Prospective Prediction
Prediction Index
898
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit in CMAI definitely non-inferior to and maybe superior to brexpiprazole)
Technical Prediction
SUCCESS (statistically significant clinical benefit in CMAI)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
177 days in advance
Readout Data Interpretation
AXS05 failed to meet any primary and secondary efficacy endpoints
Press Release
Prediction Result
Prediction Accuracy
Missed Prediction
Due to
due to suboptimal drug MoA modelling 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
ADVANCE-2: Addressing Dementia Via Agitation-Centered Evaluation 2: A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Alzheimer's Disease Agitation
Phase
Phase 3
Status
Completed
Enrollment
408
Lead sponsor
Axsome Therapeutics, Inc.
Conditions
Agitation in Patients With Dementia of the Alzheimer's Type; Alzheimer Disease; Agitation
Interventions
DRUG: AXS-05; DRUG: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2022-09-06
Primary completion
2024-11-21
Completion
2024-12-21
Results first posted
2026-08-13
Primary outcomes
  • Cohen-Mansfield Agitation Inventory (CMAI) (Up to 5 weeks)

NCT05557409 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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