Trials / Completed
CompletedNCT04491006
A Study of ATH-1017 in Mild to Moderate Alzheimer's Disease
A Randomized, Placebo-Controlled, Translational Study of ATH-1017 in Subjects With Mild to Moderate Alzheimer's Disease
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 77 (actual)
- Sponsor
- LeonaBio · Industry
- Sex
- All
- Age
- 55 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to evaluate treatment effects of ATH-1017 (fosgonimeton) in mild to moderate Alzheimer's subjects with a randomized treatment duration of 26-weeks.
Detailed description
This study is designed to assess the correlation of the functional translational biomarker P300 latency and change in ADAS-Cog11 induced by ATH-1017 therapy, over 26-week randomized, double-blind treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ATH-1017 | Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe |
| DRUG | Placebo | Daily subcutaneous (SC) injection of Placebo in a pre-filled syringe |
Timeline
- Start date
- 2020-11-23
- Primary completion
- 2022-05-20
- Completion
- 2022-05-20
- First posted
- 2020-07-29
- Last updated
- 2023-06-12
- Results posted
- 2023-06-12
Locations
13 sites across 2 countries: United States, Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04491006. Inclusion in this directory is not an endorsement.