Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects
- Conditions
- Early Alzheimer's Disease
- Registration Number
- NCT06304883
- Lead Sponsor
- Alzheon Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 285
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Primary cognitive efficacy endpoint 1 Week 52 Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-Cog 13), from baseline of Phase 3 core study (ALZ-801-AD301) to Week 52 of this long-term extension study (ALZ-801-AD351).
Primary cognitive efficacy endpoint 2 Week 52 Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-Cog 13), from baseline of this study to Week 52.
Primary imaging biomarker endpoint 2 Week 52 Change from baseline in total hippocampal volume (mm3) as measured by Magnetic Resonance Imaging (MRI), from baseline of this study to Week 52.
Incidence, Nature, and Severity of Treatment Emergent Adverse events (TEAEs) Week 52 Safety and tolerability as measured by incidence, nature and severity of treatment emergent adverse events (TEAE), serious TEAE, and TEAE leading to withdrawal.
Primary imaging biomarker endpoint 1 Week 52 Change from baseline in total hippocampal volume (mm3) as measured by Magnetic Resonance Imaging (MRI), from baseline of Phase 3 core study (ALZ-801-AD301) to Week 52 of this long-term extension study (ALZ-801-AD351).
- Secondary Outcome Measures
Name Time Method Secondary global assessment efficacy endpoint Week 52 Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) scores
Secondary cognitive efficacy endpoint 1 Week 52 Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 11
Secondary fluid biomarker endpoint Week 52 Change from baseline in plasma p-tau181, Aβ 42, and Aβ 40 levels
Secondary cognitive efficacy endpoint 2 Week 52 Change from baseline in Neuropsychiatric Inventory
Secondary cognitive efficacy endpoint 3 Week 52 Change from baseline in Mini-Mental State Examination
Secondary imaging biomarker endpoint Week 52 Change from baseline in cortical thickness and ventricular volume (mm3) as measured by Magnetic Resonance Imaging (MRI)
Secondary functional efficacy endpoint Week 52 Change from baseline in Amsterdam - Instrumental Activities of Daily Living scores
Related Research Topics
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Trial Locations
- Locations (40)
NeuroClin Glasgow Ltd
🇬🇧Motherwell, North Lanarkshire, United Kingdom
Abington Neurological Associates
🇺🇸Abington, Pennsylvania, United States
Rhode Island Mood & Memory Research Institute
🇺🇸East Providence, Rhode Island, United States
UT Health Science Center at Houston
🇺🇸Houston, Texas, United States
Re:Cognition Health
🇺🇸Fairfax, Virginia, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
OCT Research ULC (dba Okanagan Clinical Trials)
🇨🇦Kelowna, British Columbia, Canada
Centricity Research
🇨🇦Halifax, Nova Scotia, Canada
Recherches Neuro-Hippocampe Inc., d/b/a Ottawa Memory Clinic
🇨🇦Ottawa, Ontario, Canada
Kawartha Centre - Redefining Healthy Aging
🇨🇦Peterborough, Ontario, Canada
Toronto Memory Program
🇨🇦Toronto, Ontario, Canada
Re-Cognition Health Ltd Plymouth
🇬🇧Plymouth, Devon, United Kingdom
Re-Cognition Health Ltd London
🇬🇧London, Greater London, United Kingdom
Re-Cognition Health Ltd Guildford
🇬🇧Guildford, Surrey, United Kingdom
Re-Cognition Health Ltd Birmingham
🇬🇧Birmingham, West Midlands, United Kingdom
Re-Cognition Health Ltd Bristol
🇬🇧Bristol, United Kingdom
Re-Cognition Health Ltd Winchester
🇬🇧Winchester, United Kingdom
Xenoscience, Inc.
🇺🇸Phoenix, Arizona, United States
Banner Sun Health Research Institute
🇺🇸Sun City, Arizona, United States
ATP Clinical Research
🇺🇸Costa Mesa, California, United States
Torrance Clinical Research Institute
🇺🇸Lomita, California, United States
Sutter Health
🇺🇸Sacramento, California, United States
JEM Research Institute, Headlands Site
🇺🇸Atlantis, Florida, United States
K2 Medical Research, LLC
🇺🇸Maitland, Florida, United States
Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Aqualane Clinical Research
🇺🇸Naples, Florida, United States
Charter Research
🇺🇸Orlando, Florida, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
ALZ Research and Treatment Center (A.R.T.C.)
🇺🇸Wellington, Florida, United States
Premiere Research Institute
🇺🇸West Palm Beach, Florida, United States
Columbus Memory Center
🇺🇸Columbus, Georgia, United States
Fort Wayne Neurological Center
🇺🇸Fort Wayne, Indiana, United States
Headlands Research Eastern MA
🇺🇸Plymouth, Massachusetts, United States
Advanced Memory Research Center
🇺🇸Toms River, New Jersey, United States
Neurological Associates of Albany
🇺🇸Albany, New York, United States
NYU Alzheimer's Disease Research Center
🇺🇸New York, New York, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Triad Clinical Trials
🇺🇸Greensboro, North Carolina, United States
AMC Research
🇺🇸Matthews, North Carolina, United States
Center for Cognitive Health
🇺🇸Portland, Oregon, United States