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An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects (APOLLOE4)

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ClinicalTrials.gov Identifier: NCT04770220
Recruitment Status : Recruiting
First Posted : February 25, 2021
Last Update Posted : June 30, 2022
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Alzheon Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Early Alzheimer's Disease Drug: Experimental: ALZ-801 Drug: Placebo Comparator: Placebo Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a multi-center Phase 3, randomized, double-blind, placebo-controlled, parallel-group study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 19, 2021
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Primary cognitive efficacy endpoint [ Time Frame: Week 78 ]
    Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-cog 13) scores at 78 weeks

  2. Incidence, Nature, and Severity of Treatment Emergent Adverse events (TEAE) [ Time Frame: Week 78 ]
    Safety and tolerability as measured by incidence, nature and severity of treatment emergent adverse events (TEAE), serious TEAE, and TEAE leading to withdrawal.

  3. Primary fluid biomarker endpoint 1 [ Time Frame: Week 78 ]
    Change from baseline in cerebrospinal fluid p-tau181 levels in sub-study

  4. Primary fluid biomarker endpoint 2 [ Time Frame: Week 78 ]
    Change from baseline in plasma p-tau181 levels

  5. Primary imaging biomarker endpoint [ Time Frame: Week 78 ]
    Change from baseline in total hippocampal volume (mm3) as measured by Magnetic Resonance Imaging (MRI)


Secondary Outcome Measures :
  1. Functional assessment 1 [ Time Frame: Week 78 ]
    Change from baseline in Amsterdam - Instrumental Activities of Daily Living scores

  2. Global assessment [ Time Frame: Week 78 ]
    Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) scores

  3. Functional assessment 2 [ Time Frame: Week 78 ]
    Change from baseline in Disability Assessment for Dementia (DAD)scores


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04770220


Contacts
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Contact: Aidan Power (508) 861-7709 ext 220 clintrialsinfo@alzheon.com
Contact: Susan Flint (508) 861-7709 ext 220 susan.flint@alzheon.com

Locations
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Sponsors and Collaborators
Alzheon Inc.
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Susan Abushakra, MD Alzheon Inc.
More Information
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Additional Information:

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Responsible Party: Alzheon Inc.
ClinicalTrials.gov Identifier: NCT04770220    
Other Study ID Numbers: ALZ-801-AD301
R01AG065253 ( U.S. NIH Grant/Contract )
2020-005755-20 ( EudraCT Number )
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders