Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
LeonaBio
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.
Age
40–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies (SHAPE Trial)
