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

  • STATUS
    Recruiting
  • End date
    May 5, 2024
  • participants needed
    300
  • sponsor
    Alzheon Inc.
Updated on 20 September 2022
Investigator
Justine Reaume
Primary Contact
Toronto Memory Program (7.4 mi away) Contact
+78 other location
dementia
mini-mental state examination
mild dementia
apolipoprotein e

Summary

Our team of medical professionals is evaluating an investigational drug that is designed to slow the progression of Alzheimer’s disease. The study drug, ALZ-801, is a tablet that is taken twice daily. It has been well tolerated in earlier studies and may be a convenient option for Alzheimer’s patients and their families. To learn more about the clinical research study and to see if you may qualify, please visit the study website at APOLLOE4.com

Description

The APOLLOE4 Study is testing an investigational drug to find out whether it may slow the progression of Alzheimer’s disease. At this time there are no approved drugs that halt or arrest the clinical decline typical of Alzheimer’s disease. The study drug is an oral tablet that is taken twice daily with food. It has been well tolerated in earlier studies and may be a convenient option for Alzheimer’s patients. If you have early symptoms of Alzheimer’s disease, you may qualify for the APOLLOE4 Study. The study may be right for you if you’re struggling with memory loss and find everyday tasks more difficult. To learn more about the clinical research study and to see if you may qualify, please visit the study website at APOLLOE4.com


Contact: Recruitment Team Member
Phone number: 571-418-0142

Details
Condition Early Alzheimer's Disease, Alzheimer's Disease
Treatment Placebo Comparator: Placebo, Experimental: ALZ-801
Clinical Study IdentifierNCT04770220
SponsorAlzheon Inc.
Last Modified on20 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Experiencing memory loss due to Alzheimer's disease
Between 50 and 80 years of age
Positive for the APOE4/4 gene (genetic testing provided at no cost)
Accompanied by a caregiver or study partner willing to attend study visits and participate with you

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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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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