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NCT04831281 · ClinicalTrials.gov registry record · Phase 2
ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies (SHAPE Trial)
A Phase 2 study, sponsored by LeonaBio.
- Terminated
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
NCT04831281: Clinical Trial Phase 2 study, sponsored by LeonaBio.
NCT04831281 is a Phase 2 study that was terminated before completion, run by LeonaBio. The registered enrollment target is 28 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04831281, a Phase 2 study, was terminated before completion, sponsored by LeonaBio.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
Study Summary
This study is designed to evaluate the safety and treatment effects of fosgonimeton (ATH-1017) in subjects with Parkinson's Disease Dementia or Dementia with Lewy Bodies, with a randomized treatment duration of 26 weeks.
Primary Outcome
The Global Statistical Test (GST) score is a composite of the change from baseline (CFB) z-scores to Week 26 in the Alzheimer's Disease Assessment Scale - Cognitive Subscale, 13-Item Version (ADAS-Cog13; range 0-85; higher scores indicate greater impairment) and Event Related Potential P300 Latency (ERP P300; longer latency (milliseconds) indicates greater impairment). This composite approach was used to assess overall change in disease status and treatment effects of ATH-1017. The GST score wa
Interventions
- DRUG Placebo
- DRUG ATH-1017
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2022-01-20 |
| Est. Completion | 2023-04-19 |
| Phase | Phase 2 |
Why NCT04831281 stopped before completion
NCT04831281 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04831281 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04831281 about?
NCT04831281 is a clinical study titled "ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies (SHAPE Trial)". This study is designed to evaluate the safety and treatment effects of fosgonimeton (ATH-1017) in subjects with Parkinson's Disease Dementia or Dementia with Lewy Bodies, with a randomized treatment duration of 26 weeks.
What is the current status of trial NCT04831281?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2022-01-20. Estimated completion is 2023-04-19.
What interventions are being tested in trial NCT04831281?
The interventions under investigation include: Placebo (DRUG), ATH-1017 (DRUG).
Who is sponsoring clinical trial NCT04831281?
This trial is sponsored by LeonaBio, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04831281's enrollment target sits among peer trials
28 1677th of 2000 higher than 304 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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