Summary

Eligibility
for people ages 50-80 (full criteria)
Location
at UCSD
Dates
study started
completion around

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

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 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.

Locations

  • UCSD Shiley-Marcos Alzheimer's Disease Research Center
    La Jolla California 92037 United States
  • Tilda Research
    Irvine California 92612 United States
  • ATP Clinical Research
    Costa Mesa California 92626 United States
  • SC3 Research Group
    Pasadena California 91105 United States
  • Sutter Neuroscience Institute
    Sacramento California 95816 United States
  • Torrance Clinical Research Institute
    Lomita California 90717 United States
  • The Neuron Clinic
    San Marcos California 92069 United States
  • Collaborative Neuroscience Research
    Long Beach California 90806 United States
  • Stanford University
    Palo Alto California 94304 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alzheon Inc.
ID
NCT04770220
Phase
Phase 3 Alzheimer's Disease Research Study
Study Type
Interventional
Participants
Expecting 300 study participants
Last Updated