Study Stopped
Solanezumab did not meet the study's primary endpoint.
Progress of Mild Alzheimer's Disease in Participants on Solanezumab Versus Placebo
EXPEDITION 3
Effect of Passive Immunization on the Progression of Mild Alzheimer's Disease: Solanezumab (LY2062430) Versus Placebo
2 other identifiers
interventional
2,129
11 countries
198
Brief Summary
To test the idea that solanezumab will slow the cognitive decline of Alzheimer's Disease (AD) as compared with placebo in participants with mild AD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2013
Typical duration for phase_3
198 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 12, 2013
CompletedFirst Posted
Study publicly available on registry
July 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedResults Posted
Study results publicly available
March 14, 2018
CompletedOctober 9, 2019
September 1, 2019
3.3 years
July 12, 2013
February 16, 2018
September 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 14 Item Subscore (ADAS-Cog14)
The ADAS is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS that was used as the primary efficacy measure consists of 14 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation, and maze completion measures. The ADAS-Cog14 scale ranges from 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.
Baseline, Week 80
Secondary Outcomes (17)
Change From Baseline in Alzheimer's Disease Cooperative Study- Instrumental Activities of Daily Living (ADCS-iADL)
Baseline, Week 80
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 11 Item Subscore (ADAS-Cog11)
Baseline, Week 80
Change From Baseline in Mini-Mental State Examination (MMSE)
Baseline, Week 80
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL)
Baseline, Week 80
Change From Baseline in Functional Activities Questionnaire (FAQ)
Baseline, Week 80
- +12 more secondary outcomes
Study Arms (2)
Solanezumab
EXPERIMENTALSolanezumab 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.
Placebo
PLACEBO COMPARATORPlacebo 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.
Interventions
Eligibility Criteria
You may qualify if:
- Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD
- 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
You may not qualify if:
- Does not have a reliable caregiver who is in frequent contact with the participant (defined as at least 10 hours per week), will accompany the participant to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (198)
Xenoscience
Phoenix, Arizona, 85004, United States
Banner Alzheimer's Institute
Phoenix, Arizona, 85006, United States
St Josephs Hospital and Medical Center
Phoenix, Arizona, 85013, United States
ANI Arizona Neurological Institute Research, PC
Sun City, Arizona, 85351, United States
Banner Sun Health Research Institute
Sun City, Arizona, 85351, United States
Center for Neurosciences
Tucson, Arizona, 85718, United States
Arizona Health Sciences Center
Tucson, Arizona, 85724, United States
American Neuropsychiatric Research Institute, Inc
Carson, California, 90746, United States
Neurology Center of North Orange County
Fullerton, California, 92835, United States
Institute for Memory Impairment & Neurological Disorders
Irvine, California, 92697, United States
University of California - San Diego
La Jolla, California, 92037, United States
Senior Clinical Trials, Inc.
Laguna Hills, California, 92653, United States
Torrance Clinical Research
Lomita, California, 90717, United States
Collaborative Neuroscience Network - CNS
Long Beach, California, 90806, United States
Apostle Clinical Trials, Inc
Long Beach, California, 90813, United States
Univ of Southern California Medical Center
Los Angeles, California, 90033, United States
University of California Los Angeles School of Medicine
Los Angeles, California, 90073, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
Hoag Memorial Hospital
Newport Beach, California, 92663, United States
Pacific Neuroscience Medical Group
Oxnard, California, 93030, United States
Anderson Clinical Research
Redlands, California, 92374, United States
University of California, Davis - Health Systems
Sacramento, California, 95817, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
Pacific Research Network Inc
San Diego, California, 92103, United States
Sharp Mesa Vista Hospital
San Diego, California, 92123, United States
San Francisco Clinical Research Center
San Francisco, California, 94109, United States
University of California, San Francisco
San Francisco, California, 94158, United States
Apex Research Institute
Santa Ana, California, 92705, United States
St. Joseph Health
Santa Rosa, California, 95403, United States
California Neuroscience Research
Sherman Oaks, California, 91403, United States
Radiant Research
Denver, Colorado, 80239, United States
Associated Neurologists of Southern Connecticut
Fairfield, Connecticut, 06824, United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510, United States
Yale University School of Medicine
New Haven, Connecticut, 06520-8020, United States
Research Center for Clinical Studies
Norwalk, Connecticut, 06851, United States
Christiana Care Research Institute
Newark, Delaware, 19713, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20057, United States
Parkinson's Disease and Movement Disorders
Boca Raton, Florida, 33486, United States
Quantum Laboratories
Deerfield Beach, Florida, 33064, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
Cohen Medical Associates P.A.
Delray Beach, Florida, 33446, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912, United States
MD Clinical
Hallandale, Florida, 33009, United States
Galiz Research
Hialeah, Florida, 33016, United States
Infinity Clinical Research . LLC
Hollywood, Florida, 33021, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Mayo Clinic of Jacksonville
Jacksonville, Florida, 32224, United States
Miami Jewish Home and Hospital for the Aged
Miami, Florida, 33137, United States
Renstar Medical Research
Ocala, Florida, 34471, United States
Compass Research
Orlando, Florida, 32806, United States
Neurology Clinical Research, Inc
Sunrise, Florida, 33351-6637, United States
Axiom Research
Tampa, Florida, 33609, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
University of South Florida
Tampa, Florida, 33613, United States
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, 33407, United States
Atlanta Center of Medical Research
Atlanta, Georgia, 30331, United States
Rush Alzheimer's Disease Center
Chicago, Illinois, 60612, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
CTT Consultants
Prairie Village, Kansas, 66206, United States
Heartland Research Associates
Wichita, Kansas, 67207, United States
Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Baptist Physician's Lexington
Lexington, Kentucky, 40503, United States
Private Office: J. Gary Booker
Shreveport, Louisiana, 71104, United States
Maine Research Associates
Auburn, Maine, 04210, United States
Maine Neurology
Scarborough, Maine, 04074, United States
PharmaSite Research Inc
Baltimore, Maryland, 21208, United States
McLean Hospital
Belmont, Massachusetts, 02478, United States
Brigham and Womens Hospital
Boston, Massachusetts, 02115, United States
Boston University Medical Center
Boston, Massachusetts, 02118, United States
ActivMed Practices & Research, Inc
Methuen, Massachusetts, 01844, United States
Boston Center for Memory
Newton, Massachusetts, 02459, United States
Northern Michigan Neurology
Traverse City, Michigan, 49684, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
Univ of Nebraska Med Center
Omaha, Nebraska, 68198, United States
Cleveland Clinic of Las Vegas
Las Vegas, Nevada, 89106, United States
Las Vegas Radiology
Las Vegas, Nevada, 89113, United States
AdvanceMed Research
Lawrenceville, New Jersey, 08648, United States
Albuquerque Neurosciences
Albuquerque, New Mexico, 87109, United States
Albany Medical College
Albany, New York, 12206, United States
Dent Neurological Institute
Amherst, New York, 14226, United States
SPRI Clinical Trials, LLC.
Brooklyn, New York, 11235, United States
New York University Medical Center
New York, New York, 10016, United States
Mount Sinai Medical Center
New York, New York, 10029-6574, United States
Columbia University Medical Center
New York, New York, 10032, United States
Richmond Behavorial Associates
Staten Island, New York, 10312, United States
PMG Research of Charlotte, LLC
Charlotte, North Carolina, 28203, United States
Behavioral Health Center Research
Charlotte, North Carolina, 28211, United States
Guilford Neurologic Associates
Greensboro, North Carolina, 27405, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103, United States
Valley Medical Research
Centerville, Ohio, 45459, United States
Ohio State Univ College Of Medicine
Columbus, Ohio, 43210, United States
Neurology Specialists Inc.
Dayton, Ohio, 45417, United States
Insight Clinical Trials
Shaker Heights, Ohio, 44122, United States
Red River Medical Center, LLC
Oklahoma City, Oklahoma, 73112, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116, United States
The Corvallis Clinic P.C.
Corvallis, Oregon, 97330, United States
Summit Research Network Inc
Portland, Oregon, 97210, United States
Drexel University College of Medicine at EPPI
Philadelphia, Pennsylvania, 19102, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, 02914, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Butler Hospital
Providence, Rhode Island, 02906, United States
Roper St. Francis Healthcare
Charleston, South Carolina, 29401, United States
Radiant Research
Greer, South Carolina, 29651, United States
University Psychiatry Associates Avera Health
Sioux Falls, South Dakota, 57105, United States
Quillen College of Medicine, East TN State University
Johnson City, Tennessee, 37604, United States
Vanderbilt Univeristy School of Medicine
Nashville, Tennessee, 37212, United States
Texas Neurology, PA
Dallas, Texas, 75214, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390, United States
Diagnostic Research Group
San Antonio, Texas, 78229, United States
Radiant Research
Murray, Utah, 84123, United States
University of Utah School of Medicine
Salt Lake City, Utah, 84108, United States
The Memory Clinic
Bennington, Vermont, 05201, United States
National Clinical Research - Norfolk Inc
Norfolk, Virginia, 23502, United States
National Clinical Research - Richmond
Richmond, Virginia, 23294, United States
Blue Ridge Research Center
Roanoke, Virginia, 24018, United States
Veterans Affairs Puget Sound Health Care System
Seattle, Washington, 98108, 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, 2010, Australia
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East Gosford, New South Wales, 2250, Australia
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Kogarah, New South Wales, 2217, Australia
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Box Hill, Victoria, 3128, Australia
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Caulfield, Victoria, 3162, Australia
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Fitzroy, Victoria, 3065, Australia
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Heidelberg, Victoria, 3081, Australia
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Subiaco, Western Australia, 06008, Australia
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London, Ontario, N6C 5J1, Canada
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Ottawa, Ontario, K1N 5C8, Canada
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Peterborough, Ontario, K9H2P4, Canada
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Toronto, Ontario, M4G 3E8, Canada
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Gatineau, Quebec, J8T 8J1, Canada
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Greenfield Park, Quebec, Canada
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Sherbrooke, Quebec, J1H1Z1, Canada
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Bron, 69677, France
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Dijon, 21033, France
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Lille, 59037, France
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Marseille, 13385, France
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Montpellier, 34295, France
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Paris, 75013, France
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Reims, 51092, France
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Rennes, 35033, France
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Strasbourg, 67098, France
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Toulouse, 31059, France
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Villeurbanne, 69100, France
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Berlin, 12203, Germany
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Böblingen, 71034, Germany
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Hanover, 30559, Germany
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Mannheim, 68165, Germany
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Munich, 81675, Germany
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Siegen, 57076, Germany
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Ulm, 89081, Germany
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Westerstede, 26655, Germany
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Florence, 50134, Italy
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Genova, 16128, Italy
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Milan, 20122, Italy
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Pisa, 56126, Italy
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Ponderano (BI), 13875, Italy
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Rome, 00161, Italy
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Torino, 10126, Italy
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Aichi, 474-8511, Japan
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Hyōgo, 670-0981, Japan
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Ibaraki, 305-8576, Japan
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Kanagawa, 247-8533, Japan
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Kobe, 655-0037, Japan
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Kyoto, 616-8255, Japan
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Osaka, 545-8586, Japan
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Shizuoka, 424-8636, Japan
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Tokushima, 770-8503, Japan
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Tokyo, 187-8551, Japan
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Bydgoszcz, 85-796, Poland
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Katowice, 40-588, Poland
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Krakow, 31-505, Poland
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Sopot, 81-824, Poland
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Szczecin, 70-215, Poland
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Warsaw, 01-813, Poland
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Barakaldo, 48903, Spain
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Barcelona, 08014, Spain
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Getafe, 28905, Spain
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Guipuzcoa, 20014, Spain
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Madrid, 28006, Spain
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Plasencia, 10600, Spain
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Salt-Girona, 17190, Spain
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Jönköping, 55185, Sweden
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Malmo, 212 24, Sweden
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Mölndal, 431 41, Sweden
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Stockholm, 14186, Sweden
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Umeå, 90185, Sweden
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Bath, Avon, BA1 3NG, United Kingdom
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Plymouth, Devon, PL6 8BX, United Kingdom
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Crowborough, East Sussex, TN6 1HB, United Kingdom
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Scotland, Glasgow, G20 0XA, United Kingdom
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Greater London, London, W1G9JF, United Kingdom
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Salford, Manchester, M6 8HD, United Kingdom
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Swindon, Wiltshire, SN3 6BW, United Kingdom
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Glasgow, G31 2ER, United Kingdom
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Newcastle, NE4 5PL, United Kingdom
Related Publications (3)
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.
PMID: 40603145DERIVEDHoldridge 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.
PMID: 36946603DERIVEDHonig 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.
PMID: 29365294DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2013
First Posted
July 16, 2013
Study Start
July 1, 2013
Primary Completion
October 1, 2016
Study Completion
February 1, 2017
Last Updated
October 9, 2019
Results First Posted
March 14, 2018
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.