Effect on Cognitive Performance and Safety/Tolerability of SSR180711C in Mild Alzheimer's Disease
Model scores of the 29,894 trials active now.
Model score 13% 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 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Terminated on 2008-07-31, after 2008-01-31 start.
Reason given by the sponsor: “safety”
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 2008-07-31. 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) (lowers risk) · Wording
Phrases that raised it: alzheimercognitiveplacebopatientperformance
Phrases that lowered it: to assessassess therelevantparticipation inclinical trial -
Accepts healthy volunteers: No (raises risk) · Who can join
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Has a data monitoring committee: Yes (raises risk) · Design
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Minimum age: 55 (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Drug's FAERS reports with a death: 11.7% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Drug's FAERS reports marked serious: 67.9% (lowers risk) · Drug's FDA history
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Number of arms: 5 (lowers risk) · Design
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Maximum age: 90 (raises risk) · Who can join
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Blinding: quadruple (lowers risk) · Design
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Responsible party: not given (raises risk) · Design
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Sponsor's past termination rate: 7.8% (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Disease area, neurology: Yes (raises risk) · Disease area
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Sponsor type: industry (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
- 2
- Number of arms
- 5 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- not given (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 2 (typical: 1)
Who can join
- Minimum age
- 55 (typical: 18)
- Maximum age
- 90 (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
- 281 (typical: 32)
- Sponsor's past termination rate
- 7.8% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 214 (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
- 3764 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 667 (typical: 412.5)
- Drug's FAERS reports marked serious
- 67.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 11.7% (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 Trial of SHR-1707 Infusion in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease NCT06114745 · started 2024 · scored riskier than 27% of active trials completed
- Effect of Different Doses of SAR110894 on Cognition in Patients With Mild to Moderate Alzheimer's Disease on Donepezil NCT01266525 · started 2011 · scored riskier than 62% of active trials completed
- Study Comparing 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease NCT00895895 · started 2009 · scored riskier than 64% of active trials terminated
- 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
- Single and Repeated Dosing Study to Assess the Safety and the Concentration-time Profile of SAR228810 in Alzheimer's Patients NCT01485302 · started 2012 · scored riskier than 60% 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.