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

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.

Study Overview

• Status: Completed
• Conditions: Dementia With Lewy Bodies; Parkinson Disease Dementia
• Intervention / Treatment: Drug: ATH-1017; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Parkinson's Disease and Movement Disorders Center of Boca Raton
    • West Palm Beach, Florida, United States, 33407
      • Premiere Research Institute
  • Georgia
    • Decatur, Georgia, United States, 30030
      • iResearch Atlanta, LLC
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Quest Research Institute
  • Oregon
    • Portland, Oregon, United States, 97210
      • Summit Research Network
    • Portland, Oregon, United States, 97225
      • Center for Cognitive Health
  • Pennsylvania
    • Plymouth Meeting, Pennsylvania, United States, 19462
      • Keystone Clinical Studies LLC
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center
    • Kirkland, Washington, United States, 98034
      • Evergreen Health Research
    • Spokane, Washington, United States, 99202
      • Inland Northwest Research LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects with confirmed diagnosis of Parkinson's disease or Dementia with Lewy Bodies
• MoCA score 11 to 23, inclusive, at screening
• Probable Parkinson's Disease Dementia or Lewy Body Dementia
• BMI between ≥ 16and ≤ 35 kg/m2 for females and between≥ 18 and ≤ 35 kg/m2 for males at Screening
• Reliable and capable support person/caregiver, who is willing to accept responsibility for supervising the treatment or, if required, administering study drug, and assessing the condition of the subject throughout the study in accordance with all protocol requirements

Exclusion Criteria:

• Hoehn-Yahr stage 5
• History of significant neurological disease other than PDD or DLB that may affect cognition at onset of dementia
• Subjects on deep brain stimulation
• History of brain MRI scan indicative of any other significant abnormality
• History of unexplained loss of consciousness, and epileptic fits
• Hearing test result considered unacceptable for auditory ERP P300 assessment
• Diagnosis of severe major depressive disorder even without psychotic features (GDS score [15-item scale] >7 at Screening)
• Significant suicide risk based on C-SSRS
• Significant psychosis (according to Diagnostic and Statistical Manual of Mental Disorders)
• Moderate or severe substance abuse disorder (according to DSM-5)
• Myocardial infarction or unstable angina within the last 6 months
• Clinically significant cardiac arrhythmia (including atrial fibrillation), cardiomyopathy, or cardiac conduction defect (note: pacemaker is acceptable)
• Clinically significant ECG abnormality at Screening
• Chronic kidney disease (eGFR < 45 mL/min using Cockcroft-Gault formula)
• Hepatic impairment with alanine aminotransferase or aspartate aminotransferase > 2 times the upper limit of normal, or Child-Pugh class B and C
• Malignant tumor within 3 years before Screening
• Memantine at any dose or combination
• Donepezil at 23 mg

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 40mg Dose; Daily subcutaneous injection of 40mg ATH-1017	Drug: ATH-1017; Daily subcutaneous injection of ATH-1017 in a pre-filled syringe
Experimental: 70mg Dose; Daily subcutaneous injection of 70mg ATH-1017	Drug: ATH-1017; Daily subcutaneous injection of ATH-1017 in a pre-filled syringe
Placebo Comparator: Placebo; Daily subcutaneous injection of Placebo	Drug: Placebo; Daily subcutaneous injection of Placebo in a pre-filled syringe

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall treatment effect of ATH-1017 as reflected by the Global Statistical Test	As reflected by the composite Global Statistical Test (GST)	Week 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event-Related Potential	Event-related potential (ERP) P300 latency change from baseline	Week 2, 12, 26
Cognition	Alzheimer's Disease Assessment Scale-Cognitive Subscale [ADAS-Cog13] change from baseline (Range of 0 to 85, where 0 is least impairment and 85 is most severe impairment)	Week 2, 12, 20, and 26
Clinical Global Impression of Change	Clinical Global Impression of Change (CGI-C) change from baseline (Range of 1 to 7, where 1 is marked improvement and 7 is marked worsening)	Week 12 and 26
Activities of Daily Living	Alzheimer's Disease Cooperative Study - Activities of Daily Living, 23-item version [ADCS-ADL23] change from baseline (Range of 0 to 78, where a higher score indicates greater function)	Week 12 and 26

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor Function	Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score	Week 12, 26

Collaborators and Investigators

• Sponsor: Athira Pharma

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2022
• Primary Completion (Actual): April 19, 2023
• Study Completion (Actual): April 19, 2023

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: April 1, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: HGF/MET; Dementia; Dementia with Lewy Bodies; ATH-1017; Parkinson's Disease Dementia; Hepatocyte Growth Factor; Neurotrophic; Event-Related Potential; ERP P300
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Tauopathies; Parkinson Disease; Dementia; Alzheimer Disease; Lewy Body Disease
• Other Study ID Numbers: ATH-1017-PD-0201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No