Status:
TERMINATED
ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies (SHAPE Trial)
Lead Sponsor:
Athira Pharma
Conditions:
Parkinson Disease Dementia
Dementia With Lewy Bodies
Eligibility:
All Genders
40-85 years
Phase:
PHASE2
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 d...
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-cont...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04831281
Start Date
January 20 2022
End Date
April 19 2023
Last Update
March 4 2025
Active Locations (10)
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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