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ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies (SHAPE Trial)

NCT04831281 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-03-04

Study results available
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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.

Conditions

  • Parkinson Disease Dementia
  • Dementia With Lewy Bodies

Interventions

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

Sponsors & Collaborators

  • Athira Pharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-20
Primary Completion
2023-04-19
Completion
2023-04-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04831281 on ClinicalTrials.gov