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PD with Non-Motor Symptoms | SHAPE Study - Athira Pharma

Once-Daily ATH-1017 Injections in Parkinson’s Disease Dementia or Dementia with Lewy Bodies

Objective

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

Principal Investigator(s)
Daniel Burdick, MD

Clinical Trial Categories

  • Parkinson's Disease
Sponsor(s)
Athira Pharma, Inc.
Contact
EvergreenHealth Research Services at 425-899-5385
or EvergreenResearch@evergreenhealth.com

Location

  • EvergreenHealth Clinical Trials
    12039 NE 128th Street, Suite 300
    Kirkland, WA 98034
    Main: 425-899-5385

Contact Us

Call us at (425) 899-5385 or use our online information request form.

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