Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

Model scores of the 29,894 trials active now.

Model score 18% for any early termination, 3% 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 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2017-03-31. 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: alzheimerplacebodementiascoreonset
  Phrases that lowered it: subjects whotrialtypethe efficacycompare
• Accepts healthy volunteers: No (raises risk) · Who can join
• Sponsor's past termination rate: 9.5% (raises risk) · Sponsor's track record
• Has a data monitoring committee: Yes (raises risk) · Design
• Disease area, neurology: Yes (raises risk) · Disease area
• Design: parallel (raises risk) · Design
• Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
• Phase: 3 (lowers risk) · Design
• Trials the sponsor started in the prior 2 years: 28 (lowers risk) · Sponsor's track record
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Blinding: quadruple (lowers risk) · Design
• Primary purpose: treatment (raises risk) · Design
• Sponsor's past trials: 95 (lowers risk) · Sponsor's track record
• Disease area, cancer: No (lowers risk) · Disease area
• Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
• Maximum age: 90 (lowers risk) · Who can join
• Minimum age: 55 (lowers risk) · Who can join
• Disease area, psychiatry: Yes (raises risk) · Disease area

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.

• A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole in the Treatment of Alzheimer's Agitation NCT01862640 · started 2013 · scored riskier than 82% of active trials completed
• A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type NCT03548584 · started 2018 · scored riskier than 55% of active trials completed
• Brexpiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type NCT03620981 · started 2018 · scored riskier than 22% of active trials completed
• Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III) NCT05665088 · started 2022 · scored riskier than 87% of active trials terminated
• An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia NCT05276830 · started 2022 · scored riskier than 70% of active trials terminated

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.