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

Key Inclusion Criteria:

• Age 55 to 85 years

• Mild-to-moderate AD dementia subjects, MMSE 14-24, CDR 1 or 2 at Screening

• Clinical diagnosis of dementia, due probably to AD, by Revised National Institute onAging-Alzheimer's Association criteria (McKhann, 2011)

• Body mass index (BMI) of ≥ 18 and ≤ 35 kg/m2 at Screening

• Reliable and capable support person/caregiver

• Treatment-free (subjects not receiving acetylcholinesterase inhibitor [AChEI]treatment), defined as:

• Treatment-naïve, OR

• Subjects who received an AChEI in the past and discontinued at least 4 weeksprior to Screening

Key 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 > 2times 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 forAlzheimer's disease) at any time, or passive immunization (i.e., monoclonalantibodies for Alzheimer's disease) within 6 months of Screening