A Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Alzheimer's Disease Agitation

Model scores of the 29,894 trials active now.

Model score 48% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 15% of the time (734 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2024-12-21. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: alzheimeradlong termterm safetythe long
  Phrases that lowered it: efficacy05healthto communicateadministration
• Accepts healthy volunteers: No (raises risk) · Who can join
• Disease area, neurology: Yes (raises risk) · Disease area
• Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
• Phase: 3 (lowers risk) · Design
• Design: parallel (raises risk) · Design
• Drug's FAERS reports with a death: 14.9% (lowers risk) · Drug's FDA history
• Minimum age: 65 (raises risk) · Who can join
• Drug's FAERS reports marked serious: 67.8% (lowers risk) · Drug's FDA history
• Has a data monitoring committee: No (lowers risk) · Design
• Disease area, psychiatry: Yes (raises risk) · Disease area
• Blinding: triple (raises risk) · Design
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Trials the sponsor started in the prior 2 years: 9 (raises risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Primary purpose: treatment (raises risk) · Design
• Keywords listed: 6 (lowers risk) · Design
• Number of arms: 2 (raises risk) · Design
• Drug's FAERS reports before start: 265672 (lowers risk) · Drug's FDA history
• Sponsor's past trials: 9 (raises risk) · Sponsor's track record
• Drug's FAERS reports in the prior 12 months: 32117 (lowers risk) · Drug's FDA history

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

• An Open-Label Study to Assess the Long-term Safety of AXS-05 in Subjects With Dementia of the Alzheimer's Type, ADVANCE-2 and ACCORD-2 Extension Study NCT06736509 · started 2024 · scored riskier than 99% of active trials terminated
• Assessing Clinical Outcomes in Alzheimer's Disease Agitation NCT04797715 · started 2020 · scored riskier than 58% of active trials completed
• Addressing Dementia Via Agitation-Centered Evaluation NCT03226522 · started 2017 · scored riskier than 23% of active trials completed
• A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation NCT05557409 · started 2022 · scored riskier than 44% of active trials completed
• A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type NCT03594123 · started 2018 · scored riskier than 66% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.