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

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 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.

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

Recruiting Locations

UT Health Science Center at Houston
Houston, Texas 77054
Contact:
Christine Farrell
713-486-0527
neuro.cognitive.research@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
Alzheon Inc.

Study Contact

Aidan Power
(508) 861-7709
clintrialsinfo@alzheon.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.