Treatment for Aggression and Agitation in Patients With Alzheimer's Disease
Model scores of the 29,894 trials active now.
Model score 17% for any early termination, 3% 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
Completed on 2011-06-30, after 2009-02-28 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 2011-06-30. 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: alzheimerequal toor equaladgreater
Phrases that lowered it: physicaltrialparticipantsexaminationkg -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 2.9% (lowers risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Minimum age: 60 (raises risk) · Who can join
-
Trials the sponsor started in the prior 2 years: 148 (lowers risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Disease area, neurology: Yes (raises risk) · Disease area
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Sponsor's past trials: 375 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Number of arms: 2 (raises risk) · Design
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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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 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
- industry (typical: academic or other)
- Sponsor's past trials
- 375 (typical: 32)
- Sponsor's past termination rate
- 2.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 148 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology, psychiatry
- Drugs matched to FDA substances
- biphenyl
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
- Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease NCT01735630 · started 2012 · scored riskier than 57% of active trials completed
- An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia NCT05276830 · started 2022 · scored riskier than 70% of active trials terminated
- Efficacy of ORM-12741 on Agitation/Aggression Symptoms in Alzheimer's Disease NCT02471196 · started 2015 · scored riskier than 50% of active trials completed
- A Study of Lanabecestat (LY3314814) in Participants With Mild Alzheimer's Disease Dementia NCT02783573 · started 2016 · scored riskier than 99% of active trials terminated
- A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation NCT05557409 · started 2022 · 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.