Biodistribution, Pharmacokinetics, and Safety of F-18 THK-5351 PET in Alzheimer's Disease Patients and Healthy Subjects.(Positron Emission Tomograph )

NCT02686216 on ClinicalTrials.gov Phase 1 Chang Gung Memorial Hospital (academic or other) Started 2015-12-31 Completed

Riskier than 11% of active trials

Model scores of the 29,894 trials active now.

Model score 8% 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 14% of the time (201 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2016-11-30, after 2015-12-31 start.

The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.

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 2016-11-30. 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

Accepts healthy volunteers: Yes (lowers risk) · Who can join
Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: heartalzheimersubjectscardiacad
Phrases that lowered it: healthyand safetysafety ofpharmacokineticsclinical
Sponsor's past termination rate: 2.9% (lowers risk) · Sponsor's track record
Minimum age: 20 (lowers risk) · Who can join
Disease area, psychiatry: Yes (raises risk) · Disease area
Phase: 1 (lowers risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 62 (lowers risk) · Sponsor's track record
Primary purpose: diagnostic (lowers risk) · Design
Design: single group (raises risk) · Design
Disease area, neurology: Yes (raises risk) · Disease area
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
Has a data monitoring committee: No (lowers risk) · Design
Sponsor's past trials: 102 (lowers risk) · Sponsor's track record
Maximum age: 90 (lowers risk) · Who can join
Number of arms: 1 (raises risk) · Design

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: 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: 1

Who can join

Minimum age: 20 (typical: 18)
Maximum age: 90 (typical: 71)
Sex: all
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 102 (typical: 32)
Sponsor's past termination rate: 2.9% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 62 (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: none matched

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 Phase I [18F]THK-5351 Positron Emission Tomography Study in Healthy Subjects and Alzheimer's Disease NCT03112096 · started 2017 · scored riskier than 19% of active trials completed
[18F]THK-5351 Positron Emission Computed Tomography Study of Normal, Mild Cognitive Impairment, Alzheimer's Disease and Other Neurodegenerative Disease NCT02656498 · started 2016 · scored riskier than 14% 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
A Longitudinal Evaluation of a Radiotracer for Use in Tau Tracking NCT03919669 · started 2019 · scored riskier than 46% of active trials completed
Comparison of PET Amyloid Imaging in Japanese and Western Subjects NCT02813070 · started 2012 · scored riskier than 63% 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.