Longitudinal Evaluation of [18F]GTP1 as a PET Radioligand for Imaging Tau in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants

NCT02640092 on ClinicalTrials.gov Phase 1 Genentech, Inc. (industry) Started 2015-12-23 Completed

Riskier than 18% of active trials

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 in 2015 or later: the model never saw it during training.

How it ended

Completed on 2019-06-11, after 2015-12-23 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 2019-06-11. 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: alzheimeradmridementiaimaging
Phrases that lowered it: healthyvolunteersscreeningclinicalrelevant
Disease area, psychiatry: Yes (raises risk) · Disease area
Has a data monitoring committee: not given (lowers risk) · Design
Disease area, neurology: Yes (raises risk) · Disease area
Design: single group (raises risk) · Design
Trials the sponsor started in the prior 2 years: 42 (lowers risk) · Sponsor's track record
Phase: 1 (lowers risk) · Design
Primary purpose: diagnostic (lowers risk) · Design
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
Sponsor type: industry (lowers risk) · Sponsor's track record
Sponsor's past termination rate: 7.2% (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Sponsor's past trials: 222 (lowers risk) · Sponsor's track record
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: not given (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 50 (typical: 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: 222 (typical: 32)
Sponsor's past termination rate: 7.2% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 42 (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

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
Tau Positron Emission Tomography (PET) Longitudinal Substudy Associated With: Study of Crenezumab Versus Placebo in Preclinical Presenilin1 (PSEN1) E280A Mutation Carriers in the Treatment of Autosomal-Dominant Alzheimer's Disease NCT03977584 · started 2019 · scored riskier than 29% of active trials completed
Imaging Tau in Alzheimer's Disease and Normal Aging NCT03373604 · started 2017 · scored riskier than 23% of active trials completed
Imaging Tau in Alzheimer's Disease and Normal Aging NCT02884492 · started 2016 · scored riskier than 19% of active trials terminated
Evaluation of [18F]RO6958948 as Tracer for Positron Emission Tomography (PET) Imaging of Tau Burden in Alzheimer's Disease Participants NCT02792179 · started 2016 · scored riskier than 29% 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.