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

Phase 2

Completed

• Conditions: Parkinson Disease Dementia; Dementia With Lewy Bodies
• Interventions: Drug: ATH-1017; Drug: Placebo

• Registration Number: NCT04831281
• Lead Sponsor: Athira Pharma

Brief 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.

Study Timeline

• Study First Submitted: 2021-04-01
• Study First Submitted QC: 2021-04-01
• Study First Posted: 2021-04-05
• Study Start: 2022-01-20
• Disposition First Posted: 2022-12-22
• Primary Completion: 2023-04-19
• Study Completion: 2023-04-19
• Status Verified: 2024-04
• Disposition First Submitted: 2024-04-10
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
40mg Dose	ATH-1017	Daily subcutaneous injection of 40mg ATH-1017
70mg Dose	ATH-1017	Daily subcutaneous injection of 70mg ATH-1017
Placebo	Placebo	Daily subcutaneous injection of Placebo

Primary Outcome Measures

Name	Time	Method
Overall treatment effect of ATH-1017 as reflected by the Global Statistical Test	Week 26	As reflected by the composite Global Statistical Test (GST)

Secondary Outcome Measures

Name	Time	Method
Cognition	Week 2, 12, 20, and 26	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)
Event-Related Potential	Week 2, 12, 26	Event-related potential (ERP) P300 latency change from baseline
Clinical Global Impression of Change	Week 12 and 26	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)
Activities of Daily Living	Week 12 and 26	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)

Trial Locations

Locations (10)

Parkinson's Disease and Movement Disorders Center of Boca Raton; 🇺🇸 Boca Raton, Florida, United States

Premiere Research Institute; 🇺🇸 West Palm Beach, Florida, United States

QUEST Research Institute; 🇺🇸 Farmington Hills, Michigan, United States

iResearch Atlanta, LLC; 🇺🇸 Decatur, Georgia, United States

Center for Cognitive Health; 🇺🇸 Portland, Oregon, United States

Summit Research Network; 🇺🇸 Portland, Oregon, United States

Northwest Clinical Research Center; 🇺🇸 Bellevue, Washington, United States

Evergreen Health Research; 🇺🇸 Kirkland, Washington, United States

Keystone Clinical Studies LLC; 🇺🇸 Plymouth Meeting, Pennsylvania, United States

Inland Northwest Research LLC; 🇺🇸 Spokane, Washington, United States