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

• Status: Recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alzheon Inc.
• Collaborator: National Institute on Aging (NIA)

Criteria

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 can not 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 Screening - Part 2 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 (> 10 years).

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