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

a study on Alzheimer's Disease

Summary

Eligibility
for people ages 50-80 (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Stephanie Lessig

Description

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.

Official Title

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety and Biomarker Effects of ALZ-801 in Subjects With Early Alzheimer's Disease and APOE4/4 Genotype

Details

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.

Keywords

Early Alzheimer's Disease Alzheimer Disease Experimental: ALZ-801 ALZ-801

Eligibility

You can join if…

Open to people ages 50-80

  • 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

You CAN'T join if...

  • 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.

Locations

  • UCSD Shiley-Marcos Alzheimer's Disease Research Center accepting new patients
    La Jolla California 92037 United States
  • Tilda Research accepting new patients
    Irvine California 92612 United States

Lead Scientist at UCSD

  • Stephanie Lessig
    Clinical Professor, Neurosciences. Authored (or co-authored) 28 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alzheon Inc.
ID
NCT04770220
Phase
Phase 3
Study Type
Interventional
Last Updated
Contact us about this trial