LONG-TERM EXTENSION OF 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
Study on the Long-Term Effects of an Investigational Medication in Early Alzheimer's Disease
James Stevens
Primary Investigator
Brief description of study
This study is being conducted to evaluate the long-term safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is an open-label trial of treatment with ALZ-801.
THIS STUDY IS ENROLLING BY INVITATION ONLY - This study is only enrolling individuals who participated in study ALZ-801-AD301 (APOLLOE4)
Detailed description of study
This is a long-term extension study of the Phase 3, multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and imaging biomarker effects of ALZ-801 in subjects with Early Alzheimer's Disease and APOE4/4 genotype. Subjects who at initial screening for the Phase 3 study were 50-80 years old, had a clinical diagnosis of AD, carried the APOE4/4 genotype, and were at the early stage of disease (Early AD], who complete at least 78 weeks of the Phase 3 study while on study medication, are eligible for enrollment. Subjects will be treated for 52 weeks with ALZ-801, followed by a 4-week safety follow-up visit after the last dose of ALZ-801. Clinical trial sites, subjects and their study partner will remain blinded to the treatment (ALZ-801 or placebo) that they received in the core Phase 3 study. 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 biomarkers of AD and neurodegeneration will be measured.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Alzheimer's Disease
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Age: 50 years - 85 years
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Gender: All
Inclusion Criteria:
- Subject has completed the Week 78 of the Phase 3 core study (ALZ-801-AD301) while on study drug.
- Subject has a reliable study partner who has sufficient contact with the subject to be able to provide accurate information about the subject's cognitive and functional abilities.
Exclusion Criteria:
- Significant worsening of medical conditions that may preclude completion of this study.
- Evidence of symptomatic or new moderate-severe radiologic ARIA at baseline.
- Has received (or plans to receive) amyloid antibodies since completing Phase 3 core study (ALZ-801-AD301).
- Subject taking any prohibited medications per protocol.
This study investigates the long-term effects of an investigational medication in individuals with early Alzheimer's disease who have the APOE4/4 genotype. The APOE4/4 genotype is a specific genetic variation associated with an increased risk of Alzheimer's disease. The purpose of this investigation is to evaluate the safety and effectiveness of the investigational medication over an extended period.
Participants in this study will receive treatment with the investigational medication for a period of 52 weeks. During this time, various assessments will be conducted to measure cognitive function, global and functional impairments, and biomarkers related to Alzheimer's disease and neurodegeneration. These assessments aim to provide comprehensive data on the medication's effects.
- Who can participate: Individuals aged 50 to 80 years who completed the initial Phase 3 study and have the APOE4/4 genotype are eligible. Participants must have a reliable study partner for accurate reporting of cognitive and functional abilities.
- Study details: Participants will take the investigational medication for 52 weeks, with a follow-up visit 4 weeks after the last dose.
- Study timelines: The study will last 52 weeks.
