ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies (SHAPE Trial)
- Conditions
- Parkinson Disease DementiaDementia With Lewy Bodies
- Interventions
- Drug: Placebo
- Registration Number
- NCT04831281
- Lead Sponsor
- Athira Pharma
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 28
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 40mg Dose ATH-1017 Daily subcutaneous injection of 40mg ATH-1017 Placebo Placebo Daily subcutaneous injection of Placebo 70mg Dose ATH-1017 Daily subcutaneous injection of 70mg ATH-1017
- Primary Outcome Measures
Name Time Method Global Statistical Test (GST) Score at Baseline 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.
- Secondary Outcome Measures
Name Time Method Event-related Potential (ERP) P300 Latency at Baseline Baseline ERP P300 was a method of recording brain activity elicited by external stimuli, for example (e.g.), an oddball auditory stimulus, particularly of working memory access. The participant had to perform a task related to auditory stimuli in order to assess the P300 component (latency). The stimulus consisted of an oddball paradigm with 2 sound stimuli. Stimuli were presented through headphones and auditory stimulation for P300 was assessed in a recording lasting up to 10 minutes. It was calculated as the average across the pre-dose values at Baseline visit.
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) at Baseline Baseline The Alzheimer's Disease Assessment Scale - Cognitive Subscale, 13-Item Version (ADAS-Cog13) is designed to measure cognitive symptom change. The test comprises 9 performance items and 4 clinician-rated items (total score ranging from 0 to 85). Higher scores indicate more severe cognitive impairment.
Trial Locations
- Locations (10)
Parkinson's Disease and Movement Disorders Center of Boca Raton
🇺🇸Boca Raton, Florida, United States
Premiere Research Institute
🇺🇸West Palm Beach, Florida, United States
QUEST Research Institute
🇺🇸Farmington Hills, Michigan, United States
iResearch Atlanta, LLC
🇺🇸Decatur, Georgia, United States
Center for Cognitive Health
🇺🇸Portland, Oregon, United States
Summit Research Network
🇺🇸Portland, Oregon, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Evergreen Health Research
🇺🇸Kirkland, Washington, United States
Keystone Clinical Studies LLC
🇺🇸Plymouth Meeting, Pennsylvania, United States
Inland Northwest Research LLC
🇺🇸Spokane, Washington, United States