Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil
Model scores of the 29,894 trials active now.
Model score 28% for any early termination, 10% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 20% of the time (607 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-07-29, after 2017-05-30 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 2022-07-29. 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
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: breast cancerchemotherapydonepezilalzheimereligible
Phrases that lowered it: drugstarting studymultipleimpairmentmedication -
Sponsor's past termination rate: 19.1% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Trials the sponsor started in the prior 2 years: 105 (lowers risk) · Sponsor's track record
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Blinding: quadruple (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 76.9% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports with a death: 13.9% (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Sponsor's past trials: 283 (lowers risk) · Sponsor's track record
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Disease area, neurology: Yes (raises risk) · Disease area
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Disease area, dermatology: Yes (raises risk) · Disease area
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Maximum age: 75 (lowers risk) · Who can join
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Collaborators: 1 (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.
The trial
Design
- Phase
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 75 (typical: 71)
- Sex
- female (typical: all)
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 283 (typical: 32)
- Sponsor's past termination rate
- 19.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 105 (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
- 17397 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2555 (typical: 412.5)
- Drug's FAERS reports marked serious
- 76.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 13.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, neurology, psychiatry, dermatology
- 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
- Study of Donepezil in Female Breast Cancer Survivors With Cognitive Dysfunction NCT01466270 · started 2012 · scored riskier than 90% of active trials completed
- A Phase 2, Randomized, Prospective Double-Blind, Single-Center, Placebo-controlled Study to Evaluate Safety, Tolerability, Target Engagement, and Efficacy of PrimeC in Patients With Mild to Moderate Alzheimer's Disease. NCT06185543 · started 2023 · scored riskier than 43% of active trials terminated
- Tetra PICASSO AD Trial: Study to Evaluate Effects of BPN14770 in Early Alzheimer's Subjects NCT03817684 · started 2019 · scored riskier than 55% of active trials completed
- MK-1942/Donepezil Interactions in Participants With Alzheimer's Disease (MK-1942-005) NCT04308304 · started 2021 · scored riskier than 88% of active trials completed
- A Dose Titration Study of CPC-201 in Patients With Dementia of Alzheimer's Type NCT02549196 · started 2015 · scored riskier than 22% 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.