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Biomarker Effects of ALZ-801 in APOE4 Carriers With Early Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04693520
Recruitment Status : Active, not recruiting
First Posted : January 5, 2021
Last Update Posted : March 17, 2023
Sponsor:
Information provided by (Responsible Party):
Alzheon Inc.

Study Description
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Brief Summary:
The study will investigate the effects of oral ALZ-801, in subjects with Early AD who have the APOE4/4 or APOE3/4 genotype, on the biomarkers of core AD pathology. The objectives of this study include determining the efficacy and safety/tolerability of ALZ-801. In addition, the study will evaluate the extended PK profile over 8 hours in 16 subjects after 65 weeks of treatment.

Condition or disease Intervention/treatment Phase
Early Alzheimer's Disease Drug: ALZ-801 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Single-arm Study of the Biomarker Effects of ALZ-801 in Subjects With Early Alzheimer's Disease Who Are Carriers of the ε4 Variant of the Apolipoprotein E Gene (APOE4/4 or APOE3/4)
Actual Study Start Date : September 30, 2020
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Active treatment
ALZ-801 265 mg tablets once daily for two weeks and twice daily thereafter
 Drug: ALZ-801
ALZ-801 265 mg twice daily (BID)


Outcome Measures
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Primary Outcome Measures :
  1. Plasma Biomarker of Core AD Pathology [ Time Frame: Week 104 ]
    Percent change from baseline in p-tau181

  2. Incidence, Nature, and Severity of Treatment Emergent Adverse events (TEAE) [ Time Frame: Week 108 ]
    Safety and tolerability as measured by incidence, nature and severity of treatment emergent adverse events (TEAE), serious TEAE, and TEAE leading to withdrawal.

  3. Volumetric Magnetic Resonance Imaging (vMRI) Biomarker - Hippocampal Volume [ Time Frame: Week 104 ]
    Change from baseline in hippocampal volume measured in mm3


Secondary Outcome Measures :
  1. Plasma Biomarkers of AD and Neurodegeneration [ Time Frame: Week 104 ]
    Percent changes from baseline in: Aβ-40, Aβ-42,p-tau217 and plasma glial fibrillary acidic protein (GFAP),NfL

  2. vMRI Biomarker - Ventricular volume and Cortical Thickness [ Time Frame: Week 104 ]
    Change from baseline in cortical thickness measured in mm3

  3. Additional CSF Biomarkers of AD Pathology and Neurodegeneration [ Time Frame: Week 104 ]
    Percent changes from baseline for: p-tau217,Aβ-40, Aβ-42, NfL, t-tau, sTREM2, YKL-40 and neurogranin


Other Outcome Measures:
  1. Cognitive assessment - Rey Auditory Verbal Learning Test (RAVLT) [ Time Frame: 104 weeks ]
    Change from baseline in RAVLT score

  2. Cognitive Assessment - Digit Symbol Substitution Test (DSST) [ Time Frame: 104 weeks ]
    Change from baseline in DSST score

  3. Functional Assessment - Amsterdam Instrumental Activities of Daily Living (A-IADL) [ Time Frame: 104 weeks ]
    Change from baseline in A-IADL score

  4. Cognitive Assessment - Mini Mental State Examination (MMSE) [ Time Frame: 104 weeks ]
    Change from baseline in MMSE score

  5. Global Assessment - Clinical Dementia Rating - Sum of Boxes (CDR-SB) [ Time Frame: 104 weeks ]
    Change from baseline in CDR-SB score


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

  1. Age between 50 and 80 years, inclusive.
  2. Early Alzheimer's Disease (AD): a diagnosis of Probable AD Dementia or Mild Cognitive Impairment (MCI) due to AD in accordance with the National Institute on Aging-Alzheimer's Association (NIA-AA) Working Group Criteria [Albert et al, 2011; McKhann et al, 2011].
  3. One of the following apolipoprotein E (APOE) genotypes - either APOE4/4 (homozygous) or APOE3/4 (heterozygous).
  4. MMSE score 22 to 30 inclusive; Clinical Dementia Rating (CDR)-Global Score of 0.5 or 1.0, and CDR Memory Box Score of ≥ 0.5.
  5. Documented confirmation of AD diagnosis by either positive amyloid positron emission tomography (PET) or positive CSF AD signature. Subjects without documented positive AD biomarker status must have a positive CSF biomarker result from a sample provided at screening.
  6. Stable doses of acetylcholinesterase for the duration of the study are allowed.

Exclusion Criteria

  1. Brain MRI at screening indicative of significant abnormality
  2. Diagnosis of neurodegenerative disorder other than AD
  3. Current diagnosis of Major Depressive Disorder (MDD)
  4. Concomitant treatment with memantine.
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): NCT04693520


Locations
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Czechia
St. Anne's University Hospital
Brno, Czechia
Motol University Hospital
Prague, Czechia
Vestra Clinics
Rychnov Nad Kněžnou, Czechia
Netherlands
Brain Research Center
Amsterdam, Netherlands
Brain Research Center
Den Bosch, Netherlands
Brain Research Center
Zwolle, Netherlands
Sponsors and Collaborators
Alzheon Inc.
Investigators
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Study Director: John Hey, PhD Alzheon Inc.
More Information
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Responsible Party: Alzheon Inc.
ClinicalTrials.gov Identifier: NCT04693520    
Other Study ID Numbers: ALZ-801-201ADBM
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: March 17, 2023
Last Verified: March 2023

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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