Alzheimer Disease Proof of Concept Study With BI 409306 Versus Placebo

Model scores of the 29,894 trials active now.

Model score 17% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 19% of the time (731 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 2017-10-09. 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: alzheimeradcognitivedementiaplacebo
  Phrases that lowered it: patients whodrugsdrugthe trialinvestigator
• Accepts healthy volunteers: No (raises risk) · Who can join
• Has a data monitoring committee: not given (lowers risk) · Design
• Phase: 2 (raises risk) · Design
• Sponsor's past termination rate: 5.2% (lowers risk) · Sponsor's track record
• Disease area, neurology: Yes (raises risk) · Disease area
• Trials the sponsor started in the prior 2 years: 133 (lowers risk) · Sponsor's track record
• Design: parallel (raises risk) · Design
• Number of arms: 5 (lowers risk) · Design
• Disease area, cancer: No (lowers risk) · Disease area
• Disease area, psychiatry: Yes (raises risk) · Disease area
• Primary purpose: treatment (raises risk) · Design
• Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
• Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
• Blinding: double (raises risk) · Design
• Sponsor's past trials: 310 (lowers risk) · Sponsor's track record
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Responsible party: sponsor (lowers risk) · Design
• Collaborators: 0 (raises risk) · Design

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.

• Study to Evaluate the Efficacy and Safety of GSK239512 in Alzheimer's Disease NCT01009255 · started 2009 · scored riskier than 50% of active trials completed
• Bryostatin Treatment of Moderately Severe Alzheimer's Disease NCT04538066 · started 2020 · scored riskier than 78% of active trials completed
• Study of Systemic and Ocular Safety and Pharmacokinetics of BI 409306 in Patients With Schizophrenia, Alzheimer's Disease, and Healthy Volunteers NCT02392468 · started 2015 · scored riskier than 13% of active trials completed
• A Study of Bryostatin in Moderately Severe to Severe Alzheimer's Disease Subjects Not On Memantine NCT03560245 · started 2018 · scored riskier than 86% of active trials completed
• Study to Assess Safety and Efficacy of PRI-002 in Patients With MCI to Mild Dementia Due to Alzheimer's Disease (AD) NCT06182085 · started 2024 · scored riskier than 38% 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.