Multiple Ascending Dose Safety, Tolerability, PK Study of AL001 in Alzheimer's Disease Patients & Healthy Adult Subjects
Model scores of the 29,894 trials active now.
Model score 8% 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 15% of the time (95 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-05-15, after 2022-05-04 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 2023-05-15. 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
-
Accepts healthy volunteers: Yes (lowers risk) · Who can join
-
Disease area, psychiatry: Yes (raises risk) · Disease area
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
-
Phase: 1/2 (raises risk) · Design
-
Design: parallel (raises risk) · Design
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: alzheimerpatientsdepressiondisorderdementia
Phrases that lowered it: healthysubjectsasthmaparticipantimpairment -
Disease area, neurology: Yes (raises risk) · Disease area
-
Number of arms: 9 (lowers risk) · Design
-
Blinding: double (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Has a data monitoring committee: No (lowers risk) · Design
-
Primary purpose: treatment (raises risk) · Design
-
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
-
Drug's FAERS reports before start: 0 (lowers risk) · Drug's FDA history
-
Keywords listed: 0 (raises risk) · Design
-
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
-
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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
- 1/2 (typical: 2)
- Number of arms
- 9 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (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
- 80 (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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (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 Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Healthy Adult Subjects NCT06921590 · started 2025 · scored riskier than 3% of active trials completed
- A Phase Ia/Ib, First-in-human (FIH) Study for Safety, Tolerability, Pharmacokinetics (PK), and Clinical Activity Evaluation of ADEL-Y01 NCT06247345 · started 2024 · scored riskier than 12% of active trials terminated
- Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of Oral ASN51 in Healthy Subjects and Subjects With Alzheimer's Disease NCT04759365 · started 2021 · scored riskier than 9% of active trials terminated
- Salsalate in Patients Mild to Moderate Alzheimer's Disease NCT03277573 · started 2017 · scored riskier than 51% of active trials completed
- Evaluating the Safety, Tolerability, Pharmacokinetics and Receptor Occupancy of BMS-984923 NCT04805983 · started 2021 · scored riskier than 12% 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.