BI 409306 in Patients With Cognitive Impairment Due to Alzheimer's Disease.
Model scores of the 29,894 trials active now.
Model score 12% 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 19% of the time (731 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2017-10-10, after 2015-01-21 start.
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2017-10-10. 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.
What moved the score
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: cognitivepatients mustprior tomonths priordementia
Phrases that lowered it: investigatorefficacyimpairmentmedical historylong -
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
-
Design: parallel (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 135 (lowers risk) · Sponsor's track record
-
Minimum age: 55 (lowers risk) · Who can join
-
Number of arms: 6 (lowers risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Disease area, psychiatry: Yes (raises risk) · Disease area
-
Drug's FAERS reports with a death: 14.5% (lowers risk) · Drug's FDA history
-
Primary purpose: treatment (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Blinding: double (raises risk) · Design
-
Drug's FAERS reports marked serious: 78.9% (lowers risk) · Drug's FDA history
-
Sponsor's past trials: 310 (lowers risk) · Sponsor's track record
-
Maximum age: not given (lowers risk) · Who can join
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.
The trial
Design
- Phase
- 2
- Number of arms
- 6 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 55 (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 310 (typical: 32)
- Sponsor's past termination rate
- 5.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 135 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 11656 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1537 (typical: 412.5)
- Drug's FAERS reports marked serious
- 78.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 14.5% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology, psychiatry
- Drugs matched to FDA substances
- donepezil
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- BI 425809 in Patients With Cognitive Impairment Due to Alzheimer's Disease. NCT02788513 · started 2016 · scored riskier than 22% of active trials completed
- Alzheimer Disease Proof of Concept Study With BI 409306 Versus Placebo NCT02240693 · started 2015 · scored riskier than 51% of active trials completed
- Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease NCT03352557 · started 2018 · scored riskier than 99% of active trials terminated
- Single Ascending Dose Study of BIIB037 in Participants With Alzheimer's Disease NCT01397539 · started 2011 · scored riskier than 87% of active trials completed
- A Study of SB-742457, Added to Donepezil for the Treatment of Mild-to-moderate Alzheimer's Disease NCT00710684 · started 2008 · scored riskier than 39% 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.