Phase 3 trial of oral ALZ-801 in Early AD patients who are homozygous for the epsilon 4 variant of the Apolipoprotein E gene (APOE4/4)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Alzheimer's Disease
  • Age: Between 50 - 80 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Has a clinical diagnosis of Alzheimer’s disease (AD) at either the Mild Cognitive Impairment (MCI) or Mild AD stage
    2. Is homozygous for the e4 allele of the APOE gene (APOE4/4)
    3. Has evidence of progressive memory loss over the last 12 months per investigator assessment
    4. Has an RBANS delayed memory index score = 85
    5. Can complete the cognitive testing and all other required study procedures
    6. Has completed at least 6 years of formal education after age of 5 years, and is able to read at minimum of 6th grade level
    7. Lives at home independently, in a senior living facility, or in an assisted living facility
    8. Has a body weight between 48-120 kg (inclusive), and body mass index (BMI) between 17-35 (inclusive)
    9. Except for a diagnosis of AD and the presence of stable medical conditions
    10. Has a reliable caregiver or study partner who is willing and able to sign an ICF, to accompany the subject to study visits, and adhere to study requirements
    11. Willing to sign the written informed consent indicating they understood the purpose of the study and the procedures of teh study
    12. Both subject and caregiver/study partner are fluent in, and able to read in English
    13. Subject and caregiver/study partner agree to be compliant with study procedures and adhere to study protocol
    14. Subject and caregiver/study partner agree not to receive or administer any prohibited concomitant medications during the study
    15. Female participants who are EITHER be of non-childbearing potential or have negative serum and urine pregnancy results and either sexually inactive or use a highly effective method of contraception

You may not be eligible for this study if the following are true:

    1. Has a screening brain MRI indicative of significant abnormality
    2. Has a diagnosis of neurodegenerative disorder other than AD
    3. Has been diagnosed with MDD
    4. Is currently taking memantine or has taken memantine within 12 weeks prior to the Screening
    5. Has a history of suicidal behavior within one year prior to screening; or has ongoing suicidal ideation with intent, with or without a specific plan or method
    6. Has a history of seizures, excluding febrile seizures of childhood or a single distant seizure
    7. Has a medically confirmed history of recent cerebral infarct or transient ischemic attack
    8. Has a lifetime history of schizophrenia, schizoaffective disorder, or bipolar disorder
    9. Has a history of, or currently has, any clinically significant ECG finding
    10. Has a history of cancer, diagnosed and treated within the last 3 years
    11. Has donated blood > 250 mL within 6 weeks prior
    12. Has a history of alcohol or drug dependence or abuse
    13. Has any significant medical condition or infection
    14. Is unable to swallow ALZ-801 tablets or has a known intolerance or hypersensitivity to tramiprosate or any of the excipients contained in the ALZ-801 tablets
    15. Has a history of human immunodeficiency virus (HIV), or hepatitis B or C



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