A Pilot Clinical Trial of Exendin-4 in Alzheimer's Disease
Model scores of the 29,894 trials active now.
Model score 17% for any early termination, 8% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 26% of the time (35 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 2016-11-18, after 2010-11-21 start.
Reason given by the sponsor: “other”
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 2016-11-18. 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: alzheimerbrainmristagedisease
Phrases that lowered it: participantsparticipantkgclinicalbmi -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 3.1% (lowers risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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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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Blinding: quadruple (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports with a death: 0.7% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 16.8% (lowers risk) · Drug's FDA history
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Sponsor's past trials: 64 (lowers risk) · Sponsor's track record
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Minimum age: 60 (lowers risk) · Who can join
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Trials the sponsor started in the prior 2 years: 5 (raises risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Number of arms: 2 (raises risk) · Design
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Disease area, metabolic: Yes (lowers risk) · Disease area
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Drug's FAERS reports before start: 38695 (lowers risk) · Drug's FDA history
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
- 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
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 60 (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: academic or other)
- Sponsor's past trials
- 64 (typical: 32)
- Sponsor's past termination rate
- 3.1% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 5 (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
- 38695 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2446 (typical: 412.5)
- Drug's FAERS reports marked serious
- 16.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology, psychiatry, metabolic, endocrine
- Drugs matched to FDA substances
- exenatide
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
- The Study of Nasal Insulin in the Fight Against Forgetfulness (SNIFF) NCT01767909 · started 2014 · scored riskier than 46% of active trials completed
- A Phase 2a Study to Investigate REM0046127 in Mild to Moderate Alzheimer's Disease NCT05478031 · started 2022 · scored riskier than 70% of active trials terminated
- SEMA4D Blockade Safety and Brain Metabolic Activity in Alzheimer's Disease (AD) NCT04381468 · started 2021 · scored riskier than 79% of active trials completed
- Safety, Tolerability, PK and PD of Posiphen® in Subjects With Early Alzheimer's Disease NCT02925650 · started 2017 · scored riskier than 97% of active trials completed
- Dose-Finding Study To Evaluate Safety, Tolerability, and Efficacy of E2609 in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (Prodromal Alzheimer's Disease) and Mild to Moderate Dementia Due to Alzheimer's Disease NCT02322021 · started 2014 · scored riskier than 70% of active trials terminated
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.