Trials / Terminated
TerminatedNCT04831281
ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies (SHAPE Trial)
A Randomized, Placebo-Controlled, Double-Blind Study of ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- LeonaBio · Industry
- Sex
- All
- Age
- 40 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The study is designed to evaluate the safety and treatment effects of ATH-1017 in subjects with Parkinson's Disease Dementia or Dementia with Lewy Bodies, with a randomized, double-blind, placebo-controlled, parallel-arm treatment duration of 26 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ATH-1017 | Daily subcutaneous injection of ATH-1017 in a pre-filled syringe |
| DRUG | Placebo | Daily subcutaneous injection of Placebo in a pre-filled syringe |
Timeline
- Start date
- 2022-01-20
- Primary completion
- 2023-04-19
- Completion
- 2023-04-19
- First posted
- 2021-04-05
- Last updated
- 2025-03-04
- Results posted
- 2025-03-04
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04831281. Inclusion in this directory is not an endorsement.