Progress of Mild Alzheimer's Disease in Participants on Solanezumab Versus Placebo
NCT ID: NCT01900665
Last Updated: 2019-10-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
2129 participants
INTERVENTIONAL
2013-07-31
2017-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Solanezumab
Solanezumab 400 milligrams (mg) every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will take this regimen for up to an additional 208 weeks.
Solanezumab
Administered Intravenously (IV)
Placebo
Placebo every 4 weeks for 76 weeks with an additional 4 weeks of assessments. Participants who complete the full 80 weeks of treatment/assessment and decide to continue will switch to solanezumab 400 mg every 4 weeks for up to an additional 208 weeks.
Placebo
Administered IV
Interventions
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Solanezumab
Administered Intravenously (IV)
Placebo
Administered IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has a Modified Hachinski Ischemia Scale score of less than or equal to 4
* Has a Mini-Mental State Examination (MMSE) score of 20 through 26 at Screening visit
* Has a Geriatric Depression Scale score of less than or equal to 6 (on the staff-administered short form)
* Has had a magnetic resonance imaging (MRI) or computerized tomography (CT) scan performed within the past 2 years that has confirmed no findings inconsistent with a diagnosis of AD
* Has a florbetapir positron emission tomography (PET) scan or cerebrospinal fluid (CSF) result consistent with the presence of amyloid pathology at screening
Exclusion Criteria
* Meets National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia
* Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study; or has a life expectancy of \<2 years
* Has had a history within the last 5 years of a serious infectious disease affecting the brain or head trauma resulting in protracted loss of consciousness
* Has a history within the last 5 years of a primary or recurrent malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate-specific antigen posttreatment
* Has a known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions
* Has received acetylcholinesterase inhibitor (AChEIs), memantine and/or other AD therapy for less than 4 months or has less than 2 months of stable therapy on these treatments
* Has received medications that affect the central nervous system (CNS), except treatments for AD, for less than 4 weeks
* Has a history of chronic alcohol or drug abuse/dependence within the past 5 years
* Has a Visit 1 MRI with results showing \>4 Amyloid-related Imaging Abnormality (ARIA), -hemorrhage /hemosiderin deposition (ARIA-H) or presence of ARIA-E (edema/effusions)
55 Years
90 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Xenoscience
Phoenix, Arizona, United States
Banner Alzheimer's Institute
Phoenix, Arizona, United States
St Josephs Hospital and Medical Center
Phoenix, Arizona, United States
ANI Arizona Neurological Institute Research, PC
Sun City, Arizona, United States
Banner Sun Health Research Institute
Sun City, Arizona, United States
Center for Neurosciences
Tucson, Arizona, United States
Arizona Health Sciences Center
Tucson, Arizona, United States
American Neuropsychiatric Research Institute, Inc
Carson, California, United States
Neurology Center of North Orange County
Fullerton, California, United States
Institute for Memory Impairment & Neurological Disorders
Irvine, California, United States
University of California - San Diego
La Jolla, California, United States
Senior Clinical Trials, Inc.
Laguna Hills, California, United States
Torrance Clinical Research
Lomita, California, United States
Collaborative Neuroscience Network - CNS
Long Beach, California, United States
Apostle Clinical Trials, Inc
Long Beach, California, United States
Univ of Southern California Medical Center
Los Angeles, California, United States
University of California Los Angeles School of Medicine
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
Hoag Memorial Hospital
Newport Beach, California, United States
Pacific Neuroscience Medical Group
Oxnard, California, United States
Anderson Clinical Research
Redlands, California, United States
University of California, Davis - Health Systems
Sacramento, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Pacific Research Network Inc
San Diego, California, United States
Sharp Mesa Vista Hospital
San Diego, California, United States
San Francisco Clinical Research Center
San Francisco, California, United States
University of California, San Francisco
San Francisco, California, United States
Apex Research Institute
Santa Ana, California, United States
St. Joseph Health
Santa Rosa, California, United States
California Neuroscience Research
Sherman Oaks, California, United States
Radiant Research
Denver, Colorado, United States
Associated Neurologists of Southern Connecticut
Fairfield, Connecticut, United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Research Center for Clinical Studies
Norwalk, Connecticut, United States
Christiana Care Research Institute
Newark, Delaware, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
Parkinson's Disease and Movement Disorders
Boca Raton, Florida, United States
Quantum Laboratories
Deerfield Beach, Florida, United States
Brain Matters Research
Delray Beach, Florida, United States
Cohen Medical Associates P.A.
Delray Beach, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States
MD Clinical
Hallandale, Florida, United States
Galiz Research
Hialeah, Florida, United States
Infinity Clinical Research . LLC
Hollywood, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Mayo Clinic of Jacksonville
Jacksonville, Florida, United States
Miami Jewish Home and Hospital for the Aged
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Compass Research
Orlando, Florida, United States
Neurology Clinical Research, Inc
Sunrise, Florida, United States
Axiom Research
Tampa, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
University of South Florida
Tampa, Florida, United States
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, United States
Atlanta Center of Medical Research
Atlanta, Georgia, United States
Rush Alzheimer's Disease Center
Chicago, Illinois, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
CTT Consultants
Prairie Village, Kansas, United States
Heartland Research Associates
Wichita, Kansas, United States
Via Christi Regional Medical Center
Wichita, Kansas, United States
Baptist Physician's Lexington
Lexington, Kentucky, United States
Private Office: J. Gary Booker
Shreveport, Louisiana, United States
Maine Research Associates
Auburn, Maine, United States
Maine Neurology
Scarborough, Maine, United States
PharmaSite Research Inc
Baltimore, Maryland, United States
McLean Hospital
Belmont, Massachusetts, United States
Brigham and Womens Hospital
Boston, Massachusetts, United States
Boston University Medical Center
Boston, Massachusetts, United States
ActivMed Practices & Research, Inc
Methuen, Massachusetts, United States
Boston Center for Memory
Newton, Massachusetts, United States
Northern Michigan Neurology
Traverse City, Michigan, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Univ of Nebraska Med Center
Omaha, Nebraska, United States
Cleveland Clinic of Las Vegas
Las Vegas, Nevada, United States
Las Vegas Radiology
Las Vegas, Nevada, United States
AdvanceMed Research
Lawrenceville, New Jersey, United States
Albuquerque Neurosciences
Albuquerque, New Mexico, United States
Albany Medical College
Albany, New York, United States
Dent Neurological Institute
Amherst, New York, United States
SPRI Clinical Trials, LLC.
Brooklyn, New York, United States
New York University Medical Center
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Richmond Behavorial Associates
Staten Island, New York, United States
PMG Research of Charlotte, LLC
Charlotte, North Carolina, United States
Behavioral Health Center Research
Charlotte, North Carolina, United States
Guilford Neurologic Associates
Greensboro, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, United States
Valley Medical Research
Centerville, Ohio, United States
Ohio State Univ College Of Medicine
Columbus, Ohio, United States
Neurology Specialists Inc.
Dayton, Ohio, United States
Insight Clinical Trials
Shaker Heights, Ohio, United States
Red River Medical Center, LLC
Oklahoma City, Oklahoma, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States
The Corvallis Clinic P.C.
Corvallis, Oregon, United States
Summit Research Network Inc
Portland, Oregon, United States
Drexel University College of Medicine at EPPI
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Butler Hospital
Providence, Rhode Island, United States
Roper St. Francis Healthcare
Charleston, South Carolina, United States
Radiant Research
Greer, South Carolina, United States
University Psychiatry Associates Avera Health
Sioux Falls, South Dakota, United States
Quillen College of Medicine, East TN State University
Johnson City, Tennessee, United States
Vanderbilt Univeristy School of Medicine
Nashville, Tennessee, United States
Texas Neurology, PA
Dallas, Texas, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Diagnostic Research Group
San Antonio, Texas, United States
Radiant Research
Murray, Utah, United States
University of Utah School of Medicine
Salt Lake City, Utah, United States
The Memory Clinic
Bennington, Vermont, United States
National Clinical Research - Norfolk Inc
Norfolk, Virginia, United States
National Clinical Research - Richmond
Richmond, Virginia, United States
Blue Ridge Research Center
Roanoke, Virginia, United States
Veterans Affairs Puget Sound Health Care System
Seattle, Washington, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Darlinghurst, New South Wales, Australia
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East Gosford, New South Wales, Australia
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Kogarah, New South Wales, Australia
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Box Hill, Victoria, Australia
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Caulfield, Victoria, Australia
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Fitzroy, Victoria, Australia
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Heidelberg, Victoria, Australia
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Subiaco, Western Australia, Australia
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Peterborough, Ontario, Canada
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Toronto, Ontario, Canada
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Gatineau, Quebec, Canada
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Greenfield Park, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Bron, , France
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Dijon, , France
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Lille, , France
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Marseille, , France
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Montpellier, , France
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Paris, , France
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Reims, , France
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Rennes, , France
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Strasbourg, , France
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Toulouse, , France
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Villeurbanne, , France
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Berlin, , Germany
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Böblingen, , Germany
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Hanover, , Germany
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Mannheim, , Germany
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Munich, , Germany
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Siegen, , Germany
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Ulm, , Germany
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Westerstede, , Germany
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Florence, , Italy
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Genova, , Italy
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Milan, , Italy
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Pisa, , Italy
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Ponderano (BI), , Italy
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Rome, , Italy
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Torino, , Italy
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Aichi, , Japan
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Hyōgo, , Japan
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Ibaraki, , Japan
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Kanagawa, , Japan
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Kobe, , Japan
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Kyoto, , Japan
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Osaka, , Japan
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Shizuoka, , Japan
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Tokushima, , Japan
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Tokyo, , Japan
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Bydgoszcz, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Sopot, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Barakaldo, , Spain
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Barcelona, , Spain
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Getafe, , Spain
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Guipuzcoa, , Spain
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Madrid, , Spain
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Plasencia, , Spain
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Salt-Girona, , Spain
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Jönköping, , Sweden
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Malmo, , Sweden
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Mölndal, , Sweden
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Stockholm, , Sweden
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Umeå, , Sweden
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Bath, Avon, United Kingdom
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Plymouth, Devon, United Kingdom
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Crowborough, East Sussex, United Kingdom
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Scotland, Glasgow, United Kingdom
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Greater London, London, United Kingdom
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Salford, Manchester, United Kingdom
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Swindon, Wiltshire, United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Glasgow, , United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Newcastle, , United Kingdom
Countries
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References
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Chandler JM, Lansdall CJ, Ye W, McDougall F, Belger M, Toth B, Mi X, Sink KM, Atkins AS. The Alzheimer's Disease Cooperative Study - Activities of Daily Living dependence score: revision and validation of an algorithm evaluating patient dependence across the spectrum of AD severity. J Prev Alzheimers Dis. 2025 Sep;12(8):100261. doi: 10.1016/j.tjpad.2025.100261. Epub 2025 Jul 1.
Holdridge KC, Yaari R, Hoban DB, Andersen S, Sims JR. Targeting amyloid beta in Alzheimer's disease: Meta-analysis of low-dose solanezumab in Alzheimer's disease with mild dementia studies. Alzheimers Dement. 2023 Oct;19(10):4619-4628. doi: 10.1002/alz.13031. Epub 2023 Mar 22.
Honig LS, Vellas B, Woodward M, Boada M, Bullock R, Borrie M, Hager K, Andreasen N, Scarpini E, Liu-Seifert H, Case M, Dean RA, Hake A, Sundell K, Poole Hoffmann V, Carlson C, Khanna R, Mintun M, DeMattos R, Selzler KJ, Siemers E. Trial of Solanezumab for Mild Dementia Due to Alzheimer's Disease. N Engl J Med. 2018 Jan 25;378(4):321-330. doi: 10.1056/NEJMoa1705971.
Other Identifiers
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H8A-MC-LZAX
Identifier Type: OTHER
Identifier Source: secondary_id
15136
Identifier Type: -
Identifier Source: org_study_id
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