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

Prior treatment

• 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.
• Medically confirmed history of recent cerebral infarct or transient ischemic attack within one year prior to screening.

Other illness

• Diagnosis of neurodegenerative disorder other than AD.

Age

• History of seizures, excluding febrile seizures of childhood or a single distant seizure (\> 5 years).

Other

• 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.

• 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