A Study of Flortaucipir PET in Healthy Volunteers and Cognitively Impaired Subjects
Model scores of the 29,894 trials active now.
Model score 11% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 8% of the time (544 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 2014-05-30, after 2013-11-13 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 2014-05-30. 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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Accepts healthy volunteers: Yes (lowers risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: adalzheimerimagingbrainevidence
Phrases that lowered it: healthyvolunteersmaletrialdaily -
Sponsor's past termination rate: 13.6% (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 52.2% (lowers risk) · Drug's FDA history
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Phase: 1 (lowers risk) · Design
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Disease area, neurology: Yes (raises risk) · Disease area
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Drug's FAERS reports with a death: 4.6% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Minimum age: 50 (lowers risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Blinding: single (lowers risk) · Design
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Number of arms: 3 (lowers risk) · Design
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Disease area, psychiatry: Yes (raises risk) · Disease area
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: diagnostic (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 9 (lowers risk) · Sponsor's track record
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Drug's FAERS reports in the prior 12 months: 606 (raises risk) · Drug's FDA history
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Maximum age: not given (lowers risk) · Who can join
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
- 1 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- parallel
- Primary purpose
- diagnostic (typical: treatment)
- Blinding
- single (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 50 (typical: 18)
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- Yes (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 22 (typical: 32)
- Sponsor's past termination rate
- 13.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 9 (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
- 1188 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 606 (typical: 412.5)
- Drug's FAERS reports marked serious
- 52.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 4.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology, psychiatry
- Drugs matched to FDA substances
- flortaucipir f18, indole
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 of 18F-AV-45 in Alzheimer's Disease (AD) and Healthy Volunteers NCT01565343 · started 2008 · scored riskier than 8% of active trials completed
- Analysis of 18F-AV-1451 PET Imaging in Cognitively Healthy, MCI, and AD Subjects NCT02016560 · started 2013 · scored riskier than 17% of active trials completed
- A Longitudinal Evaluation of a Radiotracer for Use in Tau Tracking NCT03919669 · started 2019 · scored riskier than 46% of active trials completed
- Evaluation Comparing Tau PET Radiotracers, [18F]GTP1 and [18F]PI-2620 or [18F]MK-6240 in Subjects With Normal Cognition or Prodromal to Moderate Alzheimer's Disease NCT04566003 · started 2020 · scored riskier than 56% of active trials completed
- Quantitative Evaluation of [18F]T807 as a Potential PET Radioligand for Imaging Tau in Patients With Alzheimer's Disease NCT02370524 · started 2015 · scored riskier than 23% 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.