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

• Sponsor: Athira Pharma (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04831281
• Collaborator: (none)
• Enrollment: 75
• Locations: 10
• Arms: 3
• Anticipated Duration (Months): 21.4
• Patients Per Site: 7.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease Dementia; Dementia With Lewy Bodies	Drug: ATH-1017; Drug: Placebo	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 20, 2022
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Nov 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Event-Related Potential [Week 2, 12, 26]

   Event-related potential (ERP) P300 latency change from baseline

2. 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)

3. 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)

4. 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)

Other Outcome Measures

1. Motor Function [Week 12, 26]

   Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parkinson's Disease and Movement Disorders Center of Boca Raton	Boca Raton	Florida	United States	33486
2	Premiere Research Institute	West Palm Beach	Florida	United States	33407
3	iResearch Atlanta, LLC	Decatur	Georgia	United States	30030
4	QUEST Research Institute	Farmington Hills	Michigan	United States	48334
5	Summit Research Network	Portland	Oregon	United States	97210
6	Center for Cognitive Health	Portland	Oregon	United States	97225
7	Keystone Clinical Studies LLC	Plymouth Meeting	Pennsylvania	United States	19462
8	Northwest Clinical Research Center	Bellevue	Washington	United States	98007
9	Evergreen Health Research	Kirkland	Washington	United States	98034
10	Inland Northwest Research LLC	Spokane	Washington	United States	99202

Sponsors and Collaborators

• Athira Pharma

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Athira Pharma
• ClinicalTrials.gov Identifier: NCT04831281
• Other Study ID Numbers: ATH-1017-PD-0201
• First Posted: Apr 5, 2021
• Last Update Posted: May 19, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Athira Pharma: Parkinson's Disease Dementia; Dementia with Lewy Bodies; Dementia; HGF/MET; Hepatocyte Growth Factor; Neurotrophic; ATH-1017; Event-Related Potential; ERP P300
• Additional relevant MeSH terms: Parkinson Disease; Dementia; Alzheimer Disease; Lewy Body Disease

Study Results

No Results Posted as of May 19, 2022