ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease

Exclusion Criteria

• •History of significant neurologic disease, other than AD, that may affect cognition, or concurrent with the onset of dementia
• •Subject has atypical variant presentation of AD, if known from medical history, particularly non-amnestic AD
• •History of brain MRI scan indicative of any other significant abnormality
• •Diagnosis of severe major depressive disorder even without psychotic features.
• •Significant suicide risk
• •History within 2 years of Screening, or current diagnosis of psychosis
• •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)
• •Subject has either hypertension or symptomatic hypotension
• •Clinically significant ECG abnormality at Screening
• •Chronic kidney disease with estimated glomerular filtration rate (eGFR) \<45 mL/min
• •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 in any form, combination or dosage within 4 weeks prior to Screening
• •Acetylcholinesterase inhibitors in any dosage form
• •The subject has received active amyloid or tau immunization (i.e., vaccination for Alzheimer's disease) at any time, or passive immunization (i.e., monoclonal antibodies for Alzheimer's disease) within 6 months of Screening