Potential of Florbetapir F 18 PET to Inform Clinical Diagnosis and Management of Patients With Progressive Cognitive Decline

NCT01400425 on ClinicalTrials.gov Phase 3 Avid Radiopharmaceuticals (industry) Started 2011-07-31 Completed

Riskier than 40% of active trials

Model scores of the 29,894 trials active now.

Model score 15% 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 12% of the time (422 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 2012-07-31, after 2011-07-31 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 2012-07-31. 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

Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: subjectpetimagingfemalesscreening
Phrases that lowered it: patients withgroupcompletedtrialparticipated
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Primary purpose: diagnostic (lowers risk) · Design
Phase: 3 (lowers risk) · Design
Design: single group (raises risk) · Design
Minimum age: 50 (lowers risk) · Who can join
Disease area, cancer: No (lowers risk) · Disease area
Disease area, psychiatry: Yes (raises risk) · Disease area
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
Has a data monitoring committee: No (lowers risk) · Design
Number of arms: 1 (raises risk) · Design
Trials the sponsor started in the prior 2 years: 8 (raises risk) · Sponsor's track record
Disease area, neurology: No (lowers risk) · Disease area
Sponsor's past trials: 10 (raises risk) · Sponsor's track record
Collaborators: 0 (raises risk) · Design
Maximum age: not given (raises 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: 3 (typical: 2)
Number of arms: 1 (typical: 2)
Allocation: not applicable (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: diagnostic (typical: treatment)
Blinding: 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: No (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 10 (typical: 32)
Sponsor's past termination rate: 0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 8 (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: psychiatry
Drugs matched to FDA substances: florbetapir

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

Clinical Evaluation of Florbetapir F 18 (18F-AV-45) NCT01518374 · started 2009 · scored riskier than 16% of active trials completed
Tau Screening Study in Subjects With Early Symptomatic AD NCT03467477 · started 2018 · scored riskier than 50% of active trials completed
Tau Screening Study in Patients With Early Symptomatic AD NCT03322462 · started 2017 · scored riskier than 43% 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
Imaging Characteristics of Florbetapir 18F in Patients With Frontotemporal Dementia, Alzheimer's Disease and Normal Controls. NCT01890343 · started 2009 · scored riskier than 8% 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.