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 on
Aging-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 weeks
prior 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 > 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