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

Dementia With Lewy Bodies Clinical Trial

Official title:

A Randomized, Placebo-Controlled, Double-Blind Study of ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04831281
• Other study ID #: ATH-1017-PD-0201
• Status: Completed
• Phase: Phase 2
• Start date: January 20, 2022
• Est. completion date: April 19, 2023

Study information

• Verified date: April 2024
• Source: Athira Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 19, 2023
• Est. primary completion date: April 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Dementia With Lewy Bodies
• Lewy Body Disease
• Parkinson Disease
• Parkinson Disease Dementia

Intervention

Drug:
• ATH-1017
Daily subcutaneous injection of ATH-1017 in a pre-filled syringe
• Placebo
Daily subcutaneous injection of Placebo in a pre-filled syringe

Locations

Country	Name	City	State
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Parkinson's Disease and Movement Disorders Center of Boca Raton	Boca Raton	Florida
United States	iResearch Atlanta, LLC	Decatur	Georgia
United States	QUEST Research Institute	Farmington Hills	Michigan
United States	Evergreen Health Research	Kirkland	Washington
United States	Keystone Clinical Studies LLC	Plymouth Meeting	Pennsylvania
United States	Center for Cognitive Health	Portland	Oregon
United States	Summit Research Network	Portland	Oregon
United States	Inland Northwest Research LLC	Spokane	Washington
United States	Premiere Research Institute	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Athira Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Motor Function	Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score	Week 12, 26
Primary	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	Event-Related Potential	Event-related potential (ERP) P300 latency change from baseline	Week 2, 12, 26
Secondary	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
Secondary	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
Secondary	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