Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss
NCT ID: NCT02008357
Last Updated: 2023-12-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1169 participants
INTERVENTIONAL
2014-02-28
2023-06-08
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Solanezumab/Solanezumab
Participants received 400 milligram (mg) solanezumab followed by 800 mg solanezumab and then 1600 milligram solanezumab administered intravenously (IV) every 4 weeks (Q4W) for approximately 240 weeks in double-blind placebo-controlled period.
Participants begin open label extension and received 1600 mg solanezumab Q4W for 204 weeks (from week 240 to week 444).
Solanezumab
Administered IV
Placebo/Solanezumab
Participants received placebo administered IV Q4W for approximately 240 weeks in double-blind period.
Participants begin open label extension period and received 1600 mg solanezumab Q4W for 204 weeks (from week 240 to week 444).
Placebo
Administered IV
Solanezumab
Administered IV
Interventions
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Placebo
Administered IV
Solanezumab
Administered IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has a global Clinical Dementia Rating (CDR) scale score at screening of 0
* Has a Logical Memory II score at screening of 6 to 18
* Has a florbetapir positron emission tomography (PET) scan that shows evidence of brain amyloid pathology at screening
* Has a study partner that is willing to participate as a source of information and has at least weekly contact with the participant (contact can be in-person, via telephone or electronic communication)
* All participants who complete the placebo-controlled period will be allowed to continue into the open-label period
Exclusion Criteria
* Lacks good venous access, such that intravenous drug delivery or multiple blood draws would be precluded
* Has current serious or unstable illness including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease or other conditions that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study
* Has had a history within the last 5 years of a serious infectious disease affecting the brain (including neurosyphilis, meningitis, or encephalitis) or head trauma resulting in protracted loss of consciousness
* Has had a history within the last 5 years of a primary or recurrent malignant disease with the exception of any in situ cancer that was appropriately treated and is being appropriately monitored, such as resected cutaneous squamous cell carcinoma in situ or in situ prostate cancer with normal prostate-specific antigen post-treatment
* Has a known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)
* Is clinically judged by the investigator to be at serious risk for suicide
* Has a history within the past 2 years of major depression or bipolar disorder as defined by the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM)
* Has a history within the past 5 years of chronic alcohol or drug abuse/dependence as defined by the most current version of the DSM
65 Years
85 Years
ALL
No
Sponsors
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Alzheimer's Therapeutic Research Institute
OTHER
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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University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner Health Research Institute
Phoenix, Arizona, United States
Barrow Neurological Institute
Phoenix, Arizona, United States
Banner Sun Health Research Institute
Sun City, Arizona, United States
Institute for Memory Impairment & Neurological Disorders
Irvine, California, United States
University of California - San Diego
La Jolla, California, United States
University of Southern California School of Medicine
Los Angeles, California, United States
University of California - Los Angeles
Los Angeles, California, United States
Univ of California Irvine College of Medicine
Orange, California, United States
Veterans Affairs Medical Center Palo Alto
Palo Alto, California, United States
Sutter Medical Group
Sacramento, California, United States
Univ of California San Francisco
San Francisco, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
University of California, Davis - Health Systems
Walnut Creek, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
Howard University Hospital
Washington D.C., District of Columbia, United States
Brain Matters Research
Delray Beach, Florida, United States
Mayo Clinic-Jacksonville
Jacksonville, Florida, United States
Wien Center for Clinical Research
Miami Beach, Florida, United States
Compass Research - Orlando
Orlando, Florida, United States
University of South Florida
Tampa, Florida, United States
Compass Research -The Villages
The Villages, Florida, United States
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Rush Alzheimer's Disease Center
Chicago, Illinois, United States
Great Lakes Clinical Trials
Chicago, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Hospital
Fairway, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Brigham and Womens Hospital
Boston, Massachusetts, United States
Boston University Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Univ of Nebraska Med Center
Omaha, Nebraska, United States
Cleveland Clinic of Las Vegas
Las Vegas, Nevada, United States
Dent Neurological Institute
Amherst, New York, United States
New York University Medical Center
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Case Western Reserve University
Beachwood, Ohio, United States
Tulsa Clinical Research LLC
Tulsa, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Drexel University College of Medicine at EPPI
Philadelphia, Pennsylvania, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Butler Hospital
Providence, Rhode Island, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Roper Hospital
Charleston, South Carolina, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Houston Methodist
Houston, Texas, United States
University of Washington School of Medicine
Seattle, Washington, United States
University of Wisconsin-Madison Hospital and Health Clinic
Madison, Wisconsin, 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.
Parkville, Victoria, Australia
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
London, , Canada
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Toronto, , Canada
Sunnybrook Health Sciences Centre
Toronto, , Canada
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Vancouver, , Canada
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.
Bunkyō City, , Japan
Countries
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References
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Shirzadi Z, Schultz AP, Loghmani N, Yang HS, Ford J, Yaari R, Properzi M, Yau WW, Liu L, Rafii MS, Donohue MC, Brickman AM, Jack CR Jr, Greenberg SM, Aisen P, Sperling RA, Chhatwal JP; A4 Study Team. Independent effects of white matter lesion volume and APOE varepsilon4 on ARIA-H in A4 Study. Alzheimers Dement. 2025 Oct;21(10):e70751. doi: 10.1002/alz.70751.
Digma LA, Young CB, Winer JR, Cody KA, Younes K, Sheng J, Insel PS, Rissman RA, Sperling R, Mormino EC. Continuum of Core 1 Biomarkers in Preclinical Alzheimer's Disease. medRxiv [Preprint]. 2025 Sep 19:2025.09.17.25336007. doi: 10.1101/2025.09.17.25336007.
Farina FR, Bennett M, Grill JD, Sperling R, Lawlor B, Griffith JW. Association of Alzheimer's disease concerns with amyloid burden and lifestyle behaviors in cognitively unimpaired older adults. Alzheimers Dement. 2025 Jun;21(6):e70225. doi: 10.1002/alz.70225.
Dubbelman MA, Liu A, Donohue MC, Langford O, Raman R, Rentz DM, Amariglio R, Sperling RA, Aisen PS, Marshall GA; as the A4 Study team. Changes in Daily Functioning in Association With Tau and Amyloid Among Unimpaired Older Adults With and Without Elevated Amyloid. Neurology. 2025 Jun 24;104(12):e213775. doi: 10.1212/WNL.0000000000213775. Epub 2025 May 29.
Sperling RA, Donohue MC, Raman R, Rafii MS, Johnson K, Masters CL, van Dyck CH, Iwatsubo T, Marshall GA, Yaari R, Mancini M, Holdridge KC, Case M, Sims JR, Aisen PS; A4 Study Team. Trial of Solanezumab in Preclinical Alzheimer's Disease. N Engl J Med. 2023 Sep 21;389(12):1096-1107. doi: 10.1056/NEJMoa2305032. Epub 2023 Jul 17.
Lewis CK, Bernstein OM, Grill JD, Gillen DL, Sultzer DL. Anxiety and Depressive Symptoms and Cortical Amyloid-beta Burden in Cognitively Unimpaired Older Adults. J Prev Alzheimers Dis. 2022;9(2):286-296. doi: 10.14283/jpad.2022.13.
Grober E, Lipton RB, Sperling RA, Papp KV, Johnson KA, Rentz DM, Veroff AE, Aisen PS, Ezzati A. Associations of Stages of Objective Memory Impairment With Amyloid PET and Structural MRI: The A4 Study. Neurology. 2022 Mar 29;98(13):e1327-e1336. doi: 10.1212/WNL.0000000000200046. Epub 2022 Feb 23.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of Solanezumab in Older Participants Who May be at Risk for Memory Loss (A4)
Other Identifiers
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H8A-MC-LZAZ
Identifier Type: OTHER
Identifier Source: secondary_id
15275
Identifier Type: -
Identifier Source: org_study_id