An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects

This study is being conducted to evaluate the safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is a double-blind, randomized trial with one dose of ALZ-801 compared to placebo.

Inclusion Criteria: * Clinical diagnosis of MCI or Mild Dementia due to AD consistent with the National Institute on Aging-Alzheimer's Association (NIA-AA) Working Group Criteria. * Homozygous for the ε4 allele of the apolipoprotein E gene (APOE4/4). * MMSE score at Screening of 22 to 30 (inclusive). * CDR - Global score of 0.5 or 1 and CDR Memory Box Score of ≥ 0.5. * RBANS delayed memory index score ≤ 85. * Evidence of progressive memory loss over the last 12 months per investigator assessment Exclusion Criteria: * Brain magnetic resonance imaging (MRI) indicative of significant abnormality per central reader, other than AD related atrophy. Computed tomography (CT) scan acceptable for subjects who cannot undergo MRI. * Diagnosis of neurodegenerative disorder other than AD. * Diagnosis of major depressive disorder (MDD) within one year prior to screening. * Currently taking memantine or has taken memantine within 12 weeks prior to the Baseline Visit. * History of suicidal behavior within one year prior to screening or has ongoing suicidal ideation. * History of seizures, excluding febrile seizures of childhood or a single distant seizure (\> 5 years). * Medically confirmed history of recent cerebral infarct or transient ischemic attack within one year prior to screening.