Back to resultsATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies (SHAPE Trial)
Primary Purpose
Parkinson Disease Dementia, Dementia With Lewy Bodies
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ATH-1017
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease Dementia focused on measuring Parkinson's Disease Dementia, Dementia with Lewy Bodies, Dementia, HGF/MET, Hepatocyte Growth Factor, Neurotrophic, ATH-1017, Event-Related Potential, ERP P300
Eligibility Criteria
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
Sites / Locations
- Parkinson's Disease and Movement Disorders Center of Boca Raton
- Premiere Research Institute
- iResearch Atlanta, LLC
- QUEST Research Institute
- Summit Research Network
- Center for Cognitive Health
- Keystone Clinical Studies LLC
- Northwest Clinical Research Center
- Evergreen Health Research
- Inland Northwest Research LLC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
40mg Dose
70mg Dose
Placebo
Arm Description
Daily subcutaneous injection of 40mg ATH-1017
Daily subcutaneous injection of 70mg ATH-1017
Daily subcutaneous injection of Placebo
Outcomes
Primary Outcome Measures
Overall treatment effect of ATH-1017 as reflected by the Global Statistical Test
As reflected by the composite Global Statistical Test (GST)
Secondary Outcome Measures
Event-Related Potential
Event-related potential (ERP) P300 latency change from baseline
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)
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)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04831281
Brief Title
ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies (SHAPE 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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Athira Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
40mg Dose
Arm Type
Experimental
Arm Description
Daily subcutaneous injection of 40mg ATH-1017
Arm Title
70mg Dose
Arm Type
Experimental
Arm Description
Daily subcutaneous injection of 70mg ATH-1017
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Daily subcutaneous injection of Placebo
Intervention Type
Drug
Intervention Name(s)
ATH-1017
Intervention Description
Daily subcutaneous injection of ATH-1017 in a pre-filled syringe
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Daily subcutaneous injection of Placebo in a pre-filled syringe
Primary Outcome Measure Information:
Title
Overall treatment effect of ATH-1017 as reflected by the Global Statistical Test
Description
As reflected by the composite Global Statistical Test (GST)
Time Frame
Week 26
Secondary Outcome Measure Information:
Title
Event-Related Potential
Description
Event-related potential (ERP) P300 latency change from baseline
Time Frame
Week 2, 12, 26
Title
Cognition
Description
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)
Time Frame
Week 2, 12, 20, and 26
Title
Clinical Global Impression of Change
Description
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)
Time Frame
Week 12 and 26
Title
Activities of Daily Living
Description
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)
Time Frame
Week 12 and 26
Other Pre-specified Outcome Measures:
Title
Motor Function
Description
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score
Time Frame
Week 12, 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Parkinson's Disease and Movement Disorders Center of Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Premiere Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
iResearch Atlanta, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
QUEST Research Institute
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Summit Research Network
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Center for Cognitive Health
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Keystone Clinical Studies LLC
City
Plymouth Meeting
State/Province
Pennsylvania
ZIP/Postal Code
19462
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Evergreen Health Research
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Inland Northwest Research LLC
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
12. IPD Sharing Statement
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ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies (SHAPE Trial)
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