AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants With Preclinical Alzheimer's Disease and Elevated Amyloid and Also in Participants With Early Preclinical Alzheimer's Disease and Intermediate Amyloid
- Conditions
- Interventions
- Registration Number
- NCT04468659
- Lead Sponsor
- Eisai Inc.
- Brief Summary
The primary purpose of this study is to determine whether treatment with lecanemab is superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with lecanemab is superior to placebo in reducing brain amyloid accumulation as measured by amyloi...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A45 Trial: Placebo (Core Study) Placebo Participants will receive placebo (0.9 percent \[%\] sodium chloride solution), administered as IV infusion, every two weeks from Week 0 to 94, then every four weeks from Week 96 to 216. A3 Trial: Lecanemab 5 mg/kg + 10 mg/kg (Core Study) Lecanemab Participants will receive lecanemab 5 mg/kg, administered as IV infusion, every four weeks from Week 0 to 4, then 10 mg/kg, administered as IV infusion, every four weeks from Week 8 to 216 in core study. A3 Trial: Placebo (Core Study) Placebo Participants will receive placebo (0.9% sodium chloride solution), administered as IV infusion, every four weeks from Week 0 to 216. A45 Trial: Lecanemab 5 mg/kg + 10 mg/kg (Core Study) Lecanemab Participants will receive lecanemab 5 milligram per kilogram (mg/kg), administered as intravenous (IV) infusion, every two weeks from Week 0 to 6, then 10 mg/kg, administered as IV infusion, every two weeks from Week 8 to 94, and 10 mg/kg, administered as IV infusion, every four weeks from Week 96 to 216 in core study. A45 Trial: Lecanemab 10 mg/kg (Extension Phase) Lecanemab Participants progressing to early Alzheimer's disease (EAD) during the core study (progressors) will receive lecanemab 10 mg/kg, administered as IV infusion, every two weeks after transition to the extension phase through to at least Week 216 from randomization in the core study. Participants completing the core study (completers) will enter extension phase and will receive lecanemab 10 mg/kg, administered as IV infusion, every two weeks for up to Week 312. Eligible participants receiving placebo in core study will continue to extension phase. A3 Trial: Lecanemab 10 mg/kg (Extension Phase) Lecanemab Participants progressing to EAD during the core study (progressors) will receive lecanemab 10 mg/kg, administered as IV infusion, every two weeks after transition to the extension phase through to at least Week 216 from randomization in the core study. Participants completing the core study (completers) will enter extension phase and will receive lecanemab 10 mg/kg, administered as IV infusion, every two weeks for up to Week 312. Eligible participants receiving placebo in core study will continue to extension phase.
- Primary Outcome Measures
Name Time Method A45 Trial: Change From Baseline in Preclinical Alzheimer Cognitive Composite 5 (PACC5) Score at Week 216 Baseline, Week 216 PACC5(5 components):Free/cued selective reminding test:number of words recalled without cuing/with cuing(0\[worst\]-96\[best recall\]);Delayed Paragraph Recall test: recall of 1 short story(25 bits information),immediately after reading and again after delay of 30 minutes (0\[worst\]-25\[best recall\]);Digit-symbol substitution test: Participant uses a key t...
A3 Trial: Change From Baseline in Amyloid Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at Week 216 Baseline, Week 216
- Secondary Outcome Measures
Name Time Method A45 Trial: Change From Baseline in tau Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at Weeks 96 and 216 Baseline, Week 96, Week 216 A45 Trial: Change From Baseline in Cognitive Function Index (CFI) at Week 216 Baseline, Week 216 CFI assessment to assess the participant's perceived ability to perform high-level functional tasks in daily life and sense of overall cognitive functional ability. Study participants (18 questions) and their study partners (15 questions) independently rate the participant's abilities. Total score combines participant and study partner scores, with higher sc...
A3 Trial: Change From Baseline in tau Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at Week 216 Baseline, Week 216 A45 Trial: Change From Baseline in Amyloid Positron Emission Tomography (PET) Standard Uptake Value Ratio (SUVr) at Weeks 96 and 216 Baseline, Week 96, Week 216
Trial Locations
- Locations (113)
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
🇺🇸Cleveland, Ohio, United States
Boston University
🇺🇸Boston, Massachusetts, United States
Brigham and Woman's Hospital Center for Alzheimer Research and Treatment
🇺🇸Boston, Massachusetts, United States
University of Washington Memory and Brain Wellness Center
🇺🇸Seattle, Washington, United States
Gonzalez MD & Aswad MD Health Sciences
🇺🇸Miami, Florida, United States
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Sharp Mesa Vista Hospital
🇺🇸San Diego, California, United States
Brain Research Center
🇳🇱Amsterdam, Netherlands
Brain Matters Research
🇺🇸Delray Beach, Florida, United States
K2 Medical Research
🇺🇸Maitland, Florida, United States
Wien Center for Clinical Research
🇺🇸Miami Beach, Florida, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Stanford University
🇺🇸Palo Alto, California, United States
Columbus Memory Center, PC
🇺🇸Columbus, Georgia, United States
Charter Research
🇺🇸Winter Park, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
University of Rochester
🇺🇸Rochester, New York, United States
Donald S.Marks, M.D.,P.C.
🇺🇸Plymouth, Massachusetts, United States
K2 Medical Research - The Villages
🇺🇸Lady Lake, Florida, United States
K2 Medical Research, Llc
🇺🇸Maitland, Florida, United States
AMC Research
🇺🇸Matthews, North Carolina, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Case Western Reserve University/University Hospitals
🇺🇸Beachwood, Ohio, United States
University of Texas, Southwestern MC at Dallas
🇺🇸Dallas, Texas, United States
Houston Methodist Neurological Institute
🇺🇸Houston, Texas, United States
Advanced Memory Research Institute of New Jersey
🇺🇸Toms River, New Jersey, United States
Columbia University
🇺🇸New York, New York, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
CALHN Memory Trials
🇦🇺Adelaide, South Australia, Australia
McGill University / Jewish General Hospital Memory Clinic
🇨🇦Montreal, Quebec, Canada
SIBCR
🇺🇸Seattle, Washington, United States
Fundació ACE
🇪🇸Barcelona, Spain
Centricity Research
🇨🇦Hailfax, Nova Scotia, Canada
Karolinska University Hospital
🇸🇪Stockholm, Sweden
St Vincent's Hospital Sydney
🇦🇺Darlinghurst, New South Wales, Australia
Parkwood Institute Main Building
🇨🇦London, Ontario, Canada
Barcelona Beta Brain Research Center
🇪🇸Barcelona, Spain
Toronto Memory Program
🇨🇦Toronto, Ontario, Canada
Fukuoka University Hospital
🇯🇵Fukuoka-shi, Fukuoka, Japan
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Koseikai Takeda Hospital
🇯🇵Kyoto-shi, Kyoto, Japan
Medical Corporation Heishinkai OPHAC Hospital
🇯🇵Suita-shi, Osaka, Japan
Alzheimer's Research Australia
🇦🇺Nedlands, Western Australia, Australia
Memory Clinic, Skåne University Hospital
🇸🇪Malmo, Sweden
Hospital Universitario Quirón Salud Madrid
🇪🇸Madrid, Spain
Tohoku University Hospital
🇯🇵Sendai-shi, Miyagi, Japan
Memory Clinic Sahlgrenska University Hospital
🇸🇪Molndal, Sweden
Kobe University Hospital
🇯🇵Kobe-shi, Hyogo, Japan
True North Clinical Research Inc.
🇨🇦New Minas, Nova Scotia, Canada
Fundacion CITA ALZHEIMER
🇪🇸San Sebastian, Spain
Bristol Brain Centre
🇬🇧Bristol, United Kingdom
Hospital Universitario Marqués de Valdeciila
🇪🇸Santander, Spain
St Pancras Clinical Research
🇬🇧London, United Kingdom
Duke Health Center
🇺🇸Durham, North Carolina, United States
The University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Eastern Virginia Medical School
🇺🇸Norfolk, Virginia, United States
Univeristy of California, San Francisco
🇺🇸San Francisco, California, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
National University Hospital
🇸🇬Singapore, Singapore
Tokyo Metropolitan Geriatric Hospital
🇯🇵Itabashi-ku, Tokyo, Japan
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
The University of Tokyo Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
University of Southern California
🇺🇸Los Angeles, California, United States
ICR Clinical Research Hospital Tokyo
🇯🇵Shinjuku-Ku, Tokyo, Japan
P-One Clinic, Keikokai Medical Corporation
🇯🇵Hachioji -shi, Tokyo, Japan
National Center of Neurology and Psychiatry
🇯🇵Kodaira-shi, Tokyo, Japan
Banner Alzheimer's Institute
🇺🇸Phoenix, Arizona, United States
University of Alabama, Birmingham
🇺🇸Birmingham, Alabama, United States
Imperial Memory Unit
🇬🇧London, United Kingdom
Mayo Clinic, Rochester
🇺🇸Rochester, Minnesota, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
University of South Florida - Health Byrd Alzheimer Institute
🇺🇸Tampa, Florida, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
University of Michigan (UMICH)
🇺🇸Ann Arbor, Michigan, United States
UCI MIND
🇺🇸Irvine, California, United States
Banner Sun Health Research Institute
🇺🇸Sun City, Arizona, United States
University of California, Davis
🇺🇸Walnut Creek, California, United States
Howard University
🇺🇸Washington, District of Columbia, United States
Advanced Clinical Research Network, Corp
🇺🇸Coral Gables, Florida, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
Synexus Clinical Research
🇺🇸The Villages, Florida, United States
Alzheimer's Research and Treatment Center
🇺🇸Wellington, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Summit Research Network, Oregon
🇺🇸Portland, Oregon, United States
Central States Research, LLC
🇺🇸Tulsa, Oklahoma, United States
Keystone Clinical Studies, LLC
🇺🇸Norristown, Pennsylvania, United States
Abington Neurological Associates
🇺🇸Abington, Pennsylvania, United States
Butler Hospital Memory and Aging Program
🇺🇸Providence, Rhode Island, United States
Neurology Clinic, P.C.
🇺🇸Cordova, Tennessee, United States
University of North Texas Health Sciences Center
🇺🇸Fort Worth, Texas, United States
Austin Hospital - Medical and Cognitive Research Unit
🇦🇺Ivanhoe, Victoria, Australia
Calvary Mater Newcastle
🇦🇺Waratah, New South Wales, Australia
True North Clinical Research
🇨🇦New Minas, Nova Scotia, Canada
National Center for Geriatrics and Gerontology
🇯🇵Obu-shi, Aichi, Japan
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Shonan Kamakura General Hospital
🇯🇵Kamakura-shi, Kanagawa, Japan
Glasgow Memory Clinic
🇬🇧Glasgow, United Kingdom
University of Kansas
🇺🇸Fairway, Kansas, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Ralph H. Johnson VA Medical Center
🇺🇸Charleston, South Carolina, United States
Roper St. Francis Healthcare
🇺🇸Charleston, South Carolina, United States
National Clinical Research, Inc
🇺🇸Richmond, Virginia, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States