Clinical trial NCT04831281: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: 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
Lead sponsor: Athira Pharma
Sponsor class: INDUSTRY
First posted: 2021-04-05
Enrollment: 28
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Global Statistical Test (GST) Score at Baseline
timeFrame: Baseline
Secondary outcomes:
measure: Event-related Potential (ERP) P300 Latency at Baseline
timeFrame: Baseline
measure: Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) at Baseline
timeFrame: Baseline
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute
state: Florida
city: Decatur
country: United States
facility: iResearch Atlanta, LLC
state: Georgia
city: Farmington Hills
country: United States
facility: QUEST Research Institute
state: Michigan
city: Portland
country: United States
facility: Summit Research Network
state: Oregon
city: Portland
country: United States
facility: Center for Cognitive Health
state: Oregon
city: Plymouth Meeting
country: United States
facility: Keystone Clinical Studies LLC
state: Pennsylvania
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Kirkland
country: United States
facility: Evergreen Health Research
state: Washington
city: Spokane
country: United States
facility: Inland Northwest Research LLC
state: Washington
Study officials:
References: