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

NCT04831281 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: ATH-1017-PD-0201
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 10

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.

Conditions

Parkinson Disease Dementia; Dementia With Lewy Bodies

Keywords

Parkinson's Disease Dementia; Dementia with Lewy Bodies; Dementia; HGF/MET; Hepatocyte Growth Factor; Neurotrophic; ATH-1017; Event-Related Potential; ERP P300

Outcome Measures

Primary Outcomes (1)

• Global Statistical Test (GST) Score at Baseline

  The Global Statistical Test (GST) score is a composite of the change from baseline (CFB) z-scores to Week 26 in the Alzheimer's Disease Assessment Scale - Cognitive Subscale, 13-Item Version (ADAS-Cog13; range 0-85; higher scores indicate greater impairment) and Event Related Potential P300 Latency (ERP P300; longer latency (milliseconds) indicates greater impairment). This composite approach was used to assess overall change in disease status and treatment effects of ATH-1017. The GST score was defined as a single outcome variable based on standardizing and combining individual patient-level z-score of change from baseline cognition (ADAS-Cog13) and ERP P300 latency scores. The between-group difference was calculated by subtracting the mean GST score for placebo from the mean GST score for ATH-1017. A negative value based on GST scores (ATH-1017 minus placebo) indicates a favorable response to ATH-1017, while a positive value favors placebo.

  Baseline

Secondary Outcomes (2)

• Event-related Potential (ERP) P300 Latency at Baseline

  Baseline

• Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) at Baseline

  Baseline

Study Arms (3)

40mg Dose

EXPERIMENTAL

Daily subcutaneous injection of 40mg ATH-1017

Drug: ATH-1017

70mg Dose

EXPERIMENTAL

Daily subcutaneous injection of 70mg ATH-1017

Drug: ATH-1017

Placebo

PLACEBO COMPARATOR

Daily subcutaneous injection of Placebo

Drug: Placebo

Interventions

ATH-1017 DRUG

Daily subcutaneous injection of ATH-1017 in a pre-filled syringe

40mg Dose; 70mg Dose

Placebo DRUG

Daily subcutaneous injection of Placebo in a pre-filled syringe

Placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Athira Pharma: lead

Study Sites (10)

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

Premiere Research Institute

West Palm Beach, Florida, 33407, United States

Location

iResearch Atlanta, LLC

Decatur, Georgia, 30030, United States

Location

QUEST Research Institute

Farmington Hills, Michigan, 48334, United States

Location

Summit Research Network

Portland, Oregon, 97210, United States

Location

Center for Cognitive Health

Portland, Oregon, 97225, United States

Location

Keystone Clinical Studies LLC

Plymouth Meeting, Pennsylvania, 19462, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

Evergreen Health Research

Kirkland, Washington, 98034, United States

Location

Inland Northwest Research LLC

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Lewy Body Disease; Dementia; Deafness, Autosomal Recessive 39

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

This study was stopped early prior to the accrual of the planned sample size of approximately 75 evaluable participants.

Results Point of Contact

• Title: Dr. Javier San Martin, CMO
• Organization: Athira Pharma

clinicaltrials@athira.com

1-866-725-0930

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 5, 2021
• Study Start: January 20, 2022
• Primary Completion: April 19, 2023
• Study Completion: April 19, 2023
• Last Updated: March 4, 2025
• Results First Posted: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)