Compare the Efficacy and Safety of Donepezil Hydrochloride 23 mg Treatment With Continuation of Donepezil Hydrochloride 10 mg Treatment in Japanese Subjects With Severe Alzheimer's Disease
Model scores of the 29,894 trials active now.
Model score 19% 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 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.
How it ended
Completed on 2015-03-31, after 2012-03-31 start.
The score above never used this outcome: 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.
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 2015-03-31. 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.
What moved the score
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: mgalzheimeror equalstableequal to
Phrases that lowered it: diseasesjapanesepatients whosubjects whoand safety -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 3.0% (lowers risk) · Sponsor's track record
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Disease area, neurology: Yes (raises risk) · Disease area
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Design: parallel (raises risk) · Design
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Has a data monitoring committee: not given (lowers risk) · Design
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Phase: 3 (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 22 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 76.8% (lowers risk) · Drug's FDA history
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Drug's FAERS reports with a death: 14.3% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Minimum age: 50 (raises risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Blinding: quadruple (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Keywords listed: 14 (raises risk) · Design
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Maximum age: not given (lowers risk) · Who can join
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Sponsor's past trials: 33 (lowers risk) · Sponsor's track record
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
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 14 (typical: 1)
Who can join
- Minimum age
- 50 (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
- 33 (typical: 32)
- Sponsor's past termination rate
- 3.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 22 (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
- 7827 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1226 (typical: 412.5)
- Drug's FAERS reports marked serious
- 76.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 14.3% (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
- A Study Versus E2020 10mg Followed by an Open-label Extension Phase to Explore the Safety of E2020 SR 23 mg in Japanese Subjects With Severe Alzheimer's Type Dementia NCT01276353 · started 2011 · scored riskier than 48% of active trials completed
- Optimal Dose Escalation Strategy to Successful Achievement of High Dose Donepezil 23mg NCT02550665 · started 2014 · scored riskier than 13% of active trials completed
- Study of DHP1401 in Patients With Mild-moderate Alzheimer's Disease Treated With Donepezil(DRAMA) NCT03055741 · started 2016 · scored riskier than 27% of active trials completed
- A 24-weeks, Multi-center, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Donepezil Hydrochloride in Chinese Subjects With Severe Alzheimer's Disease NCT01404169 · started 2011 · scored riskier than 84% of active trials completed
- Study to Evaluate DNL747 in Subjects With Alzheimer's Disease NCT03757325 · started 2019 · scored riskier than 44% 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.