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

Phase 3

Completed

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.

Detailed Description: This is a multi-center, double-blind study that will evaluate 265 mg twice daily (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.

Recruitment & Eligibility

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 cannot 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 Baseline 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 (> 5 years).
Medically confirmed history of recent cerebral infarct or transient ischemic attack within one year prior to screening.

Primary Outcome Measures

Name	Time	Method
Primary cognitive efficacy endpoint	Week 78	Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-cog 13) scores at 78 weeks
Incidence, Nature, and Severity of Treatment Emergent Adverse events (TEAE)	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.

Secondary Outcome Measures

Name	Time	Method
Functional assessment 1	Week 78	Change from baseline in Amsterdam - Instrumental Activities of Daily Living scores
Global assessment	Week 78	Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) scores
Functional assessment 2	Week 78	Change from baseline in Disability Assessment for Dementia (DAD)scores

Locations (91): Tilda Research
🇺🇸
Irvine, California, United States
Sandhill Research, LLC
🇺🇸
Decatur, Georgia, United States
WR-CRCN
🇺🇸
Las Vegas, Nevada, United States
Neurology Diagnostics, Inc.
🇺🇸
Dayton, Ohio, United States
Vanderbilt Center for Cognitive Medicine
🇺🇸
Nashville, Tennessee, United States
Xenoscience
🇺🇸
Phoenix, Arizona, United States
CCT Research
🇺🇸
Scottsdale, Arizona, United States
Banner Sun Health Research Institute
🇺🇸
Sun City, Arizona, United States
ATP Clinical Research
🇺🇸
Costa Mesa, California, United States
UCSD Shiley-Marcos Alzheimer's Disease Research Center
🇺🇸
La Jolla, California, United States
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Tilda Research
🇺🇸Irvine, California, United States