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An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects
Sponsor: Alzheon Inc.
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.
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
Key Details
Gender
All
Age Range
50 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
325
Start Date
2021-05-19
Completion Date
2024-07-29
Last Updated
2026-09-29
Healthy Volunteers
No
Conditions
Interventions
Experimental: ALZ-801
ALZ-801 tablet 265 mg once daily in the evening for the first 2 weeks, then ALZ-801 tablet 265 mg BID
Placebo Comparator: Placebo
Placebo tablet BID
Locations (95)
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
Tilda Research
Irvine, California, United States
UCSD Shiley-Marcos Alzheimer's Disease Research Center
La Jolla, California, United States
Torrance Clinical Research Institute
Lomita, California, United States
Collaborative NeuroScience Network LLC
Long Beach, California, United States
Stanford University
Palo Alto, California, United States
SC3 Research Group
Pasadena, California, United States
Sutter Health
Sacramento, California, United States
JEM Research Institute, Headlands Site
Atlantis, Florida, United States
Bradenton Research Center
Bradenton, Florida, United States
Galiz Research
Hialeah, Florida, United States
Alphab Global Research
Jupiter, Florida, United States
Charter Research
Lady Lake, Florida, United States
K2 Medical Research, LLC
Maitland, Florida, United States
Miami Jewish Health
Miami, Florida, United States
Y & L Advance Health Care, Inc /DBA Elite Clinical Research
Miami, 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
Headlands Research Orlando
Orlando, Florida, United States
Advanced Research Consultants
Palm Beach Gardens, Florida, United States
Quantum CNS Clinical Research
Pompano Beach, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
ALZ Research and Treatment Center (A.R.T.C.)
Stuart, 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
Sandhill Research, LLC
Decatur, Georgia, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States
Louisiana State University Health Sciences Center (LSUHSC)
Shreveport, Louisiana, United States
Headlands Research Eastern MA
Plymouth, Massachusetts, United States
WR-CRCN
Las Vegas, Nevada, 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
Kline Institute for Psychiatric Research
Orangeburg, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Triad Clinical Trials
Greensboro, North Carolina, United States
AMC Research
Matthews, North Carolina, United States
NeuroScience Research Center
Canton, Ohio, United States
Neurology Diagnostics, Inc.
Dayton, Ohio, United States
IPS Research
Oklahoma City, Oklahoma, United States
Center for Cognitive Health
Portland, Oregon, United States
Abington Neurological Associates
Abington, Pennsylvania, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States
Vanderbilt Center for Cognitive Medicine
Nashville, Tennessee, 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
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
OCT Research ULC (dba Okanagan Clinical Trials)
Kelowna, British Columbia, Canada
Centricity Research
Halifax, Nova Scotia, Canada
Centricity Research
New Minas, 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
Recherches Neuro-Hippocampe Inc. d/b/a Clinique de la Mémoire de l'Outaouais
Gatineau, Quebec, Canada
Medica 111, Spol. s r.o. - Neurologicka a Rehabilitacni Ambulance Brno, Centralni Pracoviste v Brne
Brno, Czechia
Fakultní nemocnice u sv. Anny v Brně (St. Anne's University Hospital)
Brno, Czechia
Neuropsychiatrie s.r.o.
Prague, Czechia
Vestra Clinics - Dedicated Research Clinics
Rychnov nad Kněžnou, Czechia
Centre Hospitalier Universitaire de Marseille - Hôpital de la Timone
Marseille, France
Hopital Gui de Chauliac - CHRU de Montpellier
Montpellier, France
Hopital Lariboisiere - Fernand-Widal - AP-HP
Paris, France
Centre Hospitalier Universitaire (CHU) Hopitaux de Rouen
Rouen, France
Hopitaux Universitaires de Strasbourg Centre d'Investigation Clinique
Strasbourg, France
Centre de Recherche Clinique du Gerontopole - CHU Toulouse
Toulouse, France
Centre de Recherche-Hopital Geriatrique de Charpennes
Villeurbanne, France
University Hospital RWTH Aachen Neurological Study Center
Aachen, Germany
Klinikum der Universitaet Muenchen Innenstadt
München, Germany
Universitätsklinik fuer Psychiatrie und Psychotherapie
Tübingen, Germany
Studienzentrum Nord-West
Westerstede, Germany
Memory Clinic, Landspitali University Hospital
Reykjavik, Iceland
Brain Research Center Den Bosch
's-Hertogenbosch, Netherlands
Brain Research Center Amsterdam
Amsterdam, Netherlands
Brain Research Center Zwolle
Zwolle, Netherlands
Fundacia ACE - Institut Catala de Neurociencies Aplicadas
Barcelona, Spain
Clinica Universidad de Navarra
Madrid, Spain
Hospital Clinico San Carlos
Madrid, Spain
Clinica Universidad de Navarra
Pamplona, Spain
Hospital Universitari MutuaTerrassa
Terrassa, Spain
Centro Hospital Universitario Dr. Preset
Valencia, Spain
Re-Cognition Health Ltd Plymouth
Plymouth, Devon, United Kingdom
Re-Cognition Health Ltd London
London, Greater London, United Kingdom
NeuroClin Glasgow Ltd
Motherwell, North Lanarkshire, 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
St. Pancras Clinical Research
London, United Kingdom
Re-Cognition Health Ltd Winchester
Winchester, United Kingdom