An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects
- Conditions
- Early Alzheimer's Disease
- Registration Number
- NCT04770220
- Lead Sponsor
- Alzheon Inc.
- 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
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 325
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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
Trial Locations
- Locations (91)
Brain Research Center Zwolle
🇳🇱Zwolle, Netherlands
Clinica Universidad de Navarra
🇪🇸Pamplona, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Universitari MutuaTerrassa
🇪🇸Terrassa, Spain
Centro Hospital Universitario Dr. Preset
🇪🇸Valencia, Spain
Re:Cognition Health Ltd Bristol
🇬🇧Bristol, United Kingdom
St. Pancras Clinical Research
🇬🇧London, United Kingdom
Neuropsychiatrie s.r.o.
🇨🇿Praha, Czechia
Brain Research Center Den Bosch
🇳🇱Den Bosch, Netherlands
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
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
🇺🇸Orlando, Florida, United States
K2 Medical Research, LLC
🇺🇸Maitland, Florida, United States
Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Miami Jewish Health
🇺🇸Miami, Florida, United States
Y & L Advance Health Care, Inc /DBA Elite Clinical Research
🇺🇸Miami, Florida, United States
Aqualane Clinical Research
🇺🇸Naples, 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.)
🇺🇸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
Louisiana State University Health Sciences Center (LSUHSC)
🇺🇸Shreveport, Louisiana, 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
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
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
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
🇨🇦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
Centre Hospitalier Universitaire de Marseille - Hôpital de la Timone
🇫🇷Marseille, France
Vestra Clinics - Dedicated Research Clinics
🇨🇿Rychnov Nad Kněžnou, Czechia
Hopital Gui de Chauliac - CHRU de Montpellier
🇫🇷Montpellier Cedex 5, France
Hopital Lariboisiere - Fernand-Widal - AP-HP
🇫🇷Paris Cedex 10, 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
🇩🇪Muenchen, Germany
Universitätsklinik fuer Psychiatrie und Psychotherapie
🇩🇪Tuebingen, Germany
Studienzentrum Nord-West
🇩🇪Westerstede, Germany
Memory Clinic, Landspitali University Hospital
🇮🇸Reykjavík, Iceland
Brain Research Center Amsterdam
🇳🇱Amsterdam, Netherlands
Fundacia ACE - Institut Catala de Neurociencies Aplicadas
🇪🇸Barcelona, 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 Winchester
🇬🇧Winchester, United Kingdom