[18F]MK-3328 as a Possible Novel Positron Emission Tomography (PET) Tracer for the Detection of Brain Amyloid Plaques (MK-3328-002)

NCT01385033 on ClinicalTrials.gov Phase 1 Merck Sharp & Dohme LLC (industry) Started 2011-08-19 Terminated

Riskier than 35% of active trials

Model scores of the 29,894 trials active now.

Model score 14% 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

Terminated on 2012-05-15, after 2011-08-19 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 2012-05-15. 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: alzheimeradcognitivedementiascore
Phrases that lowered it: healthyparticipantsbodyperiodparticipant
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Sponsor's past termination rate: 16.5% (raises risk) · Sponsor's track record
Disease area, neurology: Yes (raises risk) · Disease area
Phase: 1 (lowers risk) · Design
Disease area, psychiatry: Yes (raises risk) · Disease area
Primary purpose: diagnostic (lowers risk) · Design
Sponsor's past trials: 823 (raises risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Trials the sponsor started in the prior 2 years: 178 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
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
Disease area, cancer: No (lowers risk) · Disease area
Number of arms: 3 (lowers risk) · Design
Maximum age: 85 (raises risk) · Who can join
Keywords listed: 0 (raises risk) · Design
Collaborators: 0 (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: 3 (typical: 2)
Allocation: non randomized (typical: randomized)
Design: 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: 18
Maximum age: 85 (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: 823 (typical: 32)
Sponsor's past termination rate: 16.5% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 178 (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

[18F]MK-6240 Positron Emission Tomography (PET) Tracer First-in-Human Validation Study (MK-6240-001) NCT02562989 · started 2015 · scored riskier than 23% of active trials completed
[11C]MK-6884 Positron Emission Tomography (PET) Tracer Validation Trial (MK-6884-001) NCT02621606 · started 2016 · scored riskier than 15% 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
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
Beta-Amyloid Imaging With [18F]NAV4694 PET in Predicting Progression to AD in Subjects MCI NCT01812213 · started 2013 · scored riskier than 44% 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.