Biomarker Effects of ALZ-801 in APOE4 Carriers With Early Alzheimer's Disease

Inclusion Criteria 1. Age between 50 and 80 years, inclusive. 2. Early Alzheimer's Disease (AD): a diagnosis of Probable AD Dementia or Mild Cognitive Impairment (MCI) due to AD in accordance with the National Institute on Aging-Alzheimer's Association (NIA-AA) Working Group Criteria \[Albert et al, 2011; McKhann et al, 2011\]. 3. One of the following apolipoprotein E (APOE) genotypes - either APOE4/4 (homozygous) or APOE3/4 (heterozygous). 4. MMSE score 22 to 30 inclusive; Clinical Dementia Rating (CDR)-Global Score of 0.5 or 1.0, and CDR Memory Box Score of ≥ 0.5. 5. Documented confirmation of AD diagnosis by either positive amyloid positron emission tomography (PET) or positive CSF AD signature. Subjects without documented positive AD biomarker status must have a positive CSF biomarker result from a sample provided at screening. 6. Stable doses of acetylcholinesterase for the duration of the study are allowed. Exclusion Criteria 1. Brain MRI at screening indicative of significant abnormality 2. Diagnosis of neurodegenerative disorder other than AD 3. Current diagnosis of Major Depressive Disorder (MDD) 4. Concomitant treatment with memantine.