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

Purpose

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.

Condition

  • Early Alzheimer's Disease

Eligibility

Eligible Ages
Between 50 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This is a multi-center Phase 3, randomized, double-blind, placebo-controlled, parallel-group study.
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ALZ-801
ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.
  • Drug: Experimental: ALZ-801
    ALZ-801 tablet 265 mg BID
Placebo Comparator
Placebo
Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study
  • Drug: Placebo Comparator: Placebo
    Placebo tablet BID

More Details

Status
Active, not recruiting
Sponsor
Alzheon Inc.

Study Contact

Detailed Description

This is a multi-center, double-blind study that will evaluate 265 mg BID of ALZ-801, an oral tablet, over 78 weeks as a treatment for subjects (50-80 years old) with Early AD who are homozygous for the ε4 allele of the apolipoprotein gene (APOE4 homozygous or APOE4/4). The primary efficacy outcome assessment is a measure of cognition (ADAS-cog 13). Additional measures of global and functional impairments will also be assessed. Imaging and soluble biomarkers of AD and neurodegeneration will be measured and a sub-study to evaluate cerebrospinal fluid (CSF) biomarkers is also included.