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

  • STATUS
    Recruiting
  • End date
    May 28, 2024
  • participants needed
    300
  • sponsor
    Alzheon Inc.
Updated on 28 August 2021
Investigator
Aidan Power
Primary Contact
True North Clinical Research (4.7 mi away) Contact
+74 other location

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.

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 4 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.

Details
Condition Early Alzheimer's Disease
Treatment Placebo Comparator: Placebo, Experimental: ALZ-801
Clinical Study IdentifierNCT04770220
SponsorAlzheon Inc.
Last Modified on28 August 2021

Eligibility

Yes No Not Sure

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 4 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
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