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.
Full Title
A Randomized, Placebo-Controlled, Double-Blind Study of ATH-1017 Treatment in Subjects with Parkinson's Disease Dementia or Dementia with Lewy Bodies
Status
Currently Enrolling
Who may be eligible to participate?
Male and female, 40 to 85 years, with a confirmed diagnosis of probable idiopathic Parkinson's Disease or probable Lewy Body Dementia (LBD) for at least 1 year. Other inclusion/exclusion criteria apply.
What does participation involve?
- The study will be conducted on an outpatient basis.
- During the double-blind treatment period, clinic visits will take place on Day 1 and at Weeks 2, 6, 12, 16, 20, and 26, with a safety follow-up visit at Week 30.
- Study drug/placebo will be administered by subcutaneous (SC) injection once daily, preferably during daytime.
- Participants will receive 1 syringe/day of one of the following:
- 70 mg/ml of ATH-1017
- 40 mg/ml of ATH-1017
- Placebo
Trial Phase
Phase 2
EvergreenHealth Study ID
ATH-1017-PD-0201
ClinicalTrial.gov ID
NCT04831281
