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NCT04488419 · ClinicalTrials.gov registry record · Phase 2
ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease
A Phase 2 study, sponsored by LeonaBio.
- Completed
- Registry status
- Phase 2
- Development phase
- 554
- Enrollment target
NCT04488419: Completed Phase 2 study, sponsored by LeonaBio.
NCT04488419 is a Phase 2 study that has completed, run by LeonaBio. The registered enrollment target is 554 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (317% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04488419, a Phase 2 study, has completed, sponsored by LeonaBio.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 554 participants
- Enrollment target
Study Summary
This study is designed to evaluate safety and efficacy of fosgonimeton (ATH-1017) in the treatment of mild to moderate Alzheimer's disease with a randomized treatment duration of 26-weeks.
Primary Outcome
The Global Statistical Test (GST) score is a composite of cognition and function, calculated as the average of two change from baseline z-scores; the z-scores are calculated for the change from baseline scores for cognition (Alzheimer's Disease Assessment Scale-Cognitive Subscale \[ADAS-Cog11\]; lower value indicates improvement) and function (Alzheimer's Disease Cooperative Study - Activities of Daily Living, 23-item version \[ADCS-ADL23\] score; higher value indicates improvement). GST is a s
Interventions
- DRUG Placebo
- DRUG ATH-1017
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 554 participants |
| Start Date | 2020-09-28 |
| Est. Completion | 2024-07-15 |
| Phase | Phase 2 |
What the finished NCT04488419 record still lists
NCT04488419 is an interventional study that assigns participants to a tested intervention. The registered 554 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (317% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04488419 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04488419 about?
NCT04488419 is a clinical study titled "ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease". This study is designed to evaluate safety and efficacy of fosgonimeton (ATH-1017) in the treatment of mild to moderate Alzheimer's disease with a randomized treatment duration of 26-weeks.
What is the current status of trial NCT04488419?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 554 participants. The study started on 2020-09-28. Estimated completion is 2024-07-15.
What interventions are being tested in trial NCT04488419?
The interventions under investigation include: Placebo (DRUG), ATH-1017 (DRUG).
Who is sponsoring clinical trial NCT04488419?
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 NCT04488419's enrollment target sits among peer trials
554 60th of 2000 higher than 1,941 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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