AzTrials
AzTrials

Alzheimer's DiseasePhase 3EXPEDITION 3NCT01900665

Progress of Mild Alzheimer's Disease in Participants on Solanezumab Versus Placebo

A Phase 3 study testing Solanezumab in people with Alzheimer's Disease, run by Eli Lilly and Company at 198 sites in 11 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 to 90 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
Solanezumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,129 participants
Where
198 sitesin 11 countries
Study dates
Jul 2013to Feb 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

198 sites in 11 countries.

198 sites in 11 countries

United States120 sites

  • Albany Medical College

    Albany, New York, 12206

  • Albuquerque Neurosciences

    Albuquerque, New Mexico, 87109

  • Dent Neurological Institute

    Amherst, New York, 14226

  • Atlanta Center of Medical Research

    Atlanta, Georgia, 30331

  • Maine Research Associates

    Auburn, Maine, 04210

  • PharmaSite Research Inc

    Baltimore, Maryland, 21208

  • McLean Hospital

    Belmont, Massachusetts, 02478

  • The Memory Clinic

    Bennington, Vermont, 05201

  • Parkinson's Disease and Movement Disorders

    Boca Raton, Florida, 33486

  • Brigham and Womens Hospital

    Boston, Massachusetts, 02115

  • Boston University Medical Center

    Boston, Massachusetts, 02118

  • SPRI Clinical Trials, LLC.

    Brooklyn, New York, 11235

  • American Neuropsychiatric Research Institute, Inc

    Carson, California, 90746

  • Valley Medical Research

    Centerville, Ohio, 45459

  • Roper St. Francis Healthcare

    Charleston, South Carolina, 29401

  • PMG Research of Charlotte, LLC

    Charlotte, North Carolina, 28203

  • Behavioral Health Center Research

    Charlotte, North Carolina, 28211

  • Rush Alzheimer's Disease Center

    Chicago, Illinois, 60612

  • Ohio State Univ College Of Medicine

    Columbus, Ohio, 43210

  • The Corvallis Clinic P.C.

    Corvallis, Oregon, 97330

  • Texas Neurology, PA

    Dallas, Texas, 75214

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75390

  • Neurology Specialists Inc.

    Dayton, Ohio, 45417

  • Quantum Laboratories

    Deerfield Beach, Florida, 33064

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • Cohen Medical Associates P.A.

    Delray Beach, Florida, 33446

  • Radiant Research

    Denver, Colorado, 80239

  • Rhode Island Mood & Memory Research Institute

    East Providence, Rhode Island, 02914

  • Alexian Brothers Medical Center

    Elk Grove Village, Illinois, 60007

  • Associated Neurologists of Southern Connecticut

    Fairfield, Connecticut, 06824

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida, 33912

  • Neurology Center of North Orange County

    Fullerton, California, 92835

  • Guilford Neurologic Associates

    Greensboro, North Carolina, 27405

  • Radiant Research

    Greer, South Carolina, 29651

  • MD Clinical

    Hallandale, Florida, 33009

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • Galiz Research

    Hialeah, Florida, 33016

  • Infinity Clinical Research . LLC

    Hollywood, Florida, 33021

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • Institute for Memory Impairment & Neurological Disorders

    Irvine, California, 92697

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Mayo Clinic of Jacksonville

    Jacksonville, Florida, 32224

  • Quillen College of Medicine, East TN State University

    Johnson City, Tennessee, 37604

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • University of California - San Diego

    La Jolla, California, 92037

  • Senior Clinical Trials, Inc.

    Laguna Hills, California, 92653

  • Cleveland Clinic of Las Vegas

    Las Vegas, Nevada, 89106

  • Las Vegas Radiology

    Las Vegas, Nevada, 89113

  • AdvanceMed Research

    Lawrenceville, New Jersey, 08648

  • Baptist Physician's Lexington

    Lexington, Kentucky, 40503

  • Torrance Clinical Research

    Lomita, California, 90717

  • Collaborative Neuroscience Network - CNS

    Long Beach, California, 90806

  • Apostle Clinical Trials, Inc

    Long Beach, California, 90813

  • Univ of Southern California Medical Center

    Los Angeles, California, 90033

  • University of California Los Angeles School of Medicine

    Los Angeles, California, 90073

  • UCLA Medical Center

    Los Angeles, California, 90095

  • ActivMed Practices & Research, Inc

    Methuen, Massachusetts, 01844

  • Miami Jewish Home and Hospital for the Aged

    Miami, Florida, 33137

  • Radiant Research

    Murray, Utah, 84123

  • Vanderbilt Univeristy School of Medicine

    Nashville, Tennessee, 37212

  • Institute for Neurodegenerative Disorders

    New Haven, Connecticut, 06510

  • Yale University School of Medicine

    New Haven, Connecticut, 06520-8020

  • New York University Medical Center

    New York, New York, 10016

  • Mount Sinai Medical Center

    New York, New York, 10029-6574

  • Columbia University Medical Center

    New York, New York, 10032

  • Christiana Care Research Institute

    Newark, Delaware, 19713

  • Hoag Memorial Hospital

    Newport Beach, California, 92663

  • Boston Center for Memory

    Newton, Massachusetts, 02459

  • National Clinical Research - Norfolk Inc

    Norfolk, Virginia, 23502

  • Research Center for Clinical Studies

    Norwalk, Connecticut, 06851

  • Renstar Medical Research

    Ocala, Florida, 34471

  • Red River Medical Center, LLC

    Oklahoma City, Oklahoma, 73112

  • Cutting Edge Research Group

    Oklahoma City, Oklahoma, 73116

  • Univ of Nebraska Med Center

    Omaha, Nebraska, 68198

  • Compass Research

    Orlando, Florida, 32806

  • Pacific Neuroscience Medical Group

    Oxnard, California, 93030

  • Drexel University College of Medicine at EPPI

    Philadelphia, Pennsylvania, 19102

  • Xenoscience

    Phoenix, Arizona, 85004

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

  • St Josephs Hospital and Medical Center

    Phoenix, Arizona, 85013

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Summit Research Network Inc

    Portland, Oregon, 97210

  • CTT Consultants

    Prairie Village, Kansas, 66206

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Butler Hospital

    Providence, Rhode Island, 02906

  • Wake Research Associates

    Raleigh, North Carolina, 27612

  • Anderson Clinical Research

    Redlands, California, 92374

  • National Clinical Research - Richmond

    Richmond, Virginia, 23294

  • Blue Ridge Research Center

    Roanoke, Virginia, 24018

  • University of California, Davis - Health Systems

    Sacramento, California, 95817

  • University of Utah School of Medicine

    Salt Lake City, Utah, 84108

  • Diagnostic Research Group

    San Antonio, Texas, 78229

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

  • Pacific Research Network Inc

    San Diego, California, 92103

  • Sharp Mesa Vista Hospital

    San Diego, California, 92123

  • San Francisco Clinical Research Center

    San Francisco, California, 94109

  • University of California, San Francisco

    San Francisco, California, 94158

  • Apex Research Institute

    Santa Ana, California, 92705

  • St. Joseph Health

    Santa Rosa, California, 95403

  • Maine Neurology

    Scarborough, Maine, 04074

  • Veterans Affairs Puget Sound Health Care System

    Seattle, Washington, 98108

  • Insight Clinical Trials

    Shaker Heights, Ohio, 44122

  • California Neuroscience Research

    Sherman Oaks, California, 91403

  • Private Office: J. Gary Booker

    Shreveport, Louisiana, 71104

  • University Psychiatry Associates Avera Health

    Sioux Falls, South Dakota, 57105

  • Richmond Behavorial Associates

    Staten Island, New York, 10312

  • ANI Arizona Neurological Institute Research, PC

    Sun City, Arizona, 85351

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

  • Neurology Clinical Research, Inc

    Sunrise, Florida, 33351-6637

  • Axiom Research

    Tampa, Florida, 33609

  • Stedman Clinical Trials

    Tampa, Florida, 33613

  • University of South Florida

    Tampa, Florida, 33613

  • Northern Michigan Neurology

    Traverse City, Michigan, 49684

  • Center for Neurosciences

    Tucson, Arizona, 85718

  • Arizona Health Sciences Center

    Tucson, Arizona, 85724

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20057

  • Premiere Research Institute at Palm Beach Neurology

    West Palm Beach, Florida, 33407

  • Heartland Research Associates

    Wichita, Kansas, 67207

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • PMG Research of Winston-Salem, LLC

    Winston-Salem, North Carolina, 27103

Other trials in United States

France11 sites

  • 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.

    Bron, 69677

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    Dijon, 21033

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    Lille, 59037

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    Marseille, 13385

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    Montpellier, 34295

  • 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.

    Paris, 75013

  • 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.

    Reims, 51092

  • 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.

    Rennes, 35033

  • 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.

    Strasbourg, 67098

  • 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.

    Toulouse, 31059

  • 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.

    Villeurbanne, 69100

Other trials in France

Japan10 sites

  • 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.

    Aichi, 474-8511

  • 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.

    Hyōgo, 670-0981

  • 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.

    Ibaraki, 305-8576

  • 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.

    Kanagawa, 247-8533

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    Kobe, 655-0037

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    Kyoto, 616-8255

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    Osaka, 545-8586

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    Shizuoka, 424-8636

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    Tokushima, 770-8503

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    Tokyo, 187-8551

Other trials in Japan

United Kingdom9 sites

  • 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.

    Bath, Avon, BA1 3NG

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    Crowborough, East Sussex, TN6 1HB

  • 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, G31 2ER

  • 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.

    Greater London, London, W1G9JF

  • 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, NE4 5PL

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    Plymouth, Devon, PL6 8BX

  • 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.

    Salford, Manchester, M6 8HD

  • 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.

    Scotland, Glasgow, G20 0XA

  • 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.

    Swindon, Wiltshire, SN3 6BW

Other trials in United Kingdom

Australia8 sites

  • 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.

    Box Hill, Victoria, 3128

  • 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.

    Caulfield, Victoria, 3162

  • 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

  • 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.

    East Gosford, New South Wales, 2250

  • 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.

    Fitzroy, Victoria, 3065

  • 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.

    Heidelberg, Victoria, 3081

  • 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.

    Kogarah, New South Wales, 2217

  • 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.

    Subiaco, Western Australia, 06008

Other trials in Australia

Germany8 sites

  • 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.

    Berlin, 12203

  • 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.

    Böblingen, 71034

  • 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.

    Hanover, 30559

  • 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.

    Mannheim, 68165

  • 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.

    Munich, 81675

  • 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.

    Siegen, 57076

  • 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.

    Ulm, 89081

  • 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.

    Westerstede, 26655

Other trials in Germany

Canada7 sites

  • 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.

    Gatineau, Quebec, J8T 8J1

  • 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.

    Greenfield Park, Quebec

  • 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.

    London, Ontario, N6C 5J1

  • 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.

    Ottawa, Ontario, K1N 5C8

  • 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.

    Peterborough, Ontario, K9H2P4

  • 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.

    Sherbrooke, Quebec, J1H1Z1

  • 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.

    Toronto, Ontario, M4G 3E8

Other trials in Canada

Italy7 sites

  • 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.

    Florence, 50134

  • 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.

    Genova, 16128

  • 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.

    Milan, 20122

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    Pisa, 56126

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    Ponderano (BI), 13875

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    Rome, 00161

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    Torino, 10126

Other trials in Italy

Spain7 sites

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    Barakaldo, 48903

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    Barcelona, 08014

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    Getafe, 28905

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    Guipuzcoa, 20014

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    Madrid, 28006

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    Plasencia, 10600

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    Salt-Girona, 17190

Other trials in Spain

Poland6 sites

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    Bydgoszcz, 85-796

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    Katowice, 40-588

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    Krakow, 31-505

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    Sopot, 81-824

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    Szczecin, 70-215

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    Warsaw, 01-813

Other trials in Poland

Sweden5 sites

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    Jönköping, 55185

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    Malmö, 212 24

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    Mölndal, 431 41

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    Stockholm, 14186

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    Umeå, 90185

Other trials in Sweden

About this study

Official title: Effect of Passive Immunization on the Progression of Mild Alzheimer's Disease: Solanezumab (LY2062430) Versus Placebo

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.

Being tested
Solanezumab, Placebo
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SolanezumabDrug

    Also called LY2062430, A Beta Antibody

    Administered Intravenously (IV)

  • PlaceboDrug

    Administered IV

Study groups in NCT01900665
Study groupRoleWhat they receive
SolanezumabExperimentalSolanezumab 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.
Receives: Drug: Solanezumab
PlaceboPlacebo 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 80

Secondary outcomes (17)

  1. Change From Baseline in Alzheimer's Disease Cooperative Study- Instrumental Activities of Daily Living (ADCS-iADL)

    The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.

    Measured: Baseline, Week 80

  2. Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 11 Item Subscore (ADAS-Cog11)

    The cognitive subscale of ADAS (ADAS Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.

    Measured: Baseline, Week 80

  3. Change From Baseline in Mini-Mental State Examination (MMSE)

    MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants. Total score ranges from 0 to 30; lower score indicates greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.

    Measured: Baseline, Week 80

  4. Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL)

    The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.

    Measured: Baseline, Week 80

  5. Change From Baseline in Functional Activities Questionnaire (FAQ)

    FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant's ability to perform a variety of activities ranging from financial management, shopping, playing games, food preparation, traveling, keeping appointments, keeping track of current events, and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. A negative change indicated an improvement from baseline. FAQ Total Score is the sum of 10 items, ranging from 0 (best possible outcome) to 100 (worst possible outcome). LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.

    Measured: Baseline, Week 80

  6. Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB)

    CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.

    Measured: Baseline, Week 80

  7. Change From Baseline in Neuropsychiatric Inventory (NPI)

    NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant's behavior. Total score ranges from 12 to 144; Higher scores indicate greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.

    Measured: Baseline, Week 80

  8. Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite)

    Assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (care-giving time, work status) and participants (accommodation and healthcare resource utilization) was gathered from baseline and follow-up interviews. Reported number of hospitalizations per participant up to 76 weeks. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.

    Measured: Baseline, Week 80

  9. Change From Baseline in Quality of Life in Alzheimer's Disease (QoL-AD)

    Assesses QoL for AD: participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items, rated on a 4-point scale. Sum of items=total score (range: 13 to 52). Higher scores indicate greater QoL. Participant's primary caregiver asked to complete same measure. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.

    Measured: Baseline, Week 80

  10. Change From Baseline in 5-Dimensional EuroQol Quality of Life Scale Proxy Version (EQ-5D Proxy)

    EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 3 severity levels: no, some, severe problems. Visual analog scale (VAS) assesses caregiver's impression of participant's health state; score ranges: 0 to 100 millimeter (mm). Lower scores=greater disease severity LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.

    Measured: Baseline, Week 80

  11. Change From Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS)

    Integrated Alzheimer's Disease Rating Scale is used to assess that solanezumab slows down the cognitive and functional decline associated with AD compared with placebo. iADRS is a simple linear combination of ADAS-Cog 13 or 14 and the ADCS-iADL. The scale ranges from 0 to 146, where lower scores indicate worse performance. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.

    Measured: Baseline, Week 80

  12. Percentage of Participants of Cognitive and Functional Responders

    Assess the proportion of participants who reach certain levels of cognitive and functional decline. Decline in cognition was defined as worsening from baseline by at least 6 or 9 points on the ADAS Cog14. If there is a cognitive decline of a specified cut-off or more at any time then the participant is considered a nonresponder. Functional nonresponders are participants who have not had any of the following at any time point: Clinically evident decline in ability to perform one or more basic ADL present at baseline; A clinically evident decline in ability to perform 20% or more of the instrumental ADL present at baseline; An increase in global CDR score of 1 point or more compared with baseline. A decline from no impairment to mild impairment (bADL, iADL is not considered clinically significant, but other declines of 1 or more points and any participant discontinuation within the first 6 months will be considered a non-responder.

    Measured: Baseline through Week 80

  13. Change From Baseline in Plasma Amyloid-Beta (Aβ) Species

    Concentration of amino acid peptide known as Aβ 1-42 in plasma. The change in plasma Aβ analytes after treatment were assessed separately for each plasma Aβ parameter. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.

    Measured: Baseline, Week 80

  14. Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI)

    The vMRI assessment of right and left hippocampal atrophy, is reported. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.

    Measured: Baseline, Week 80

  15. Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Solanezumab (LY2062430)

    Area Under the Concentration versus Time Curve was evaluated for Solanezumab.

    Measured: Visit 2 (Post-dose), Visit 5, 9, 15 (Pre-dose, Post-dose) and Visit 22 (Pre-dose): Pre-dose before the infusion, Post-dose 30 minutes End of Infusion

  16. Change From Baseline in Florbetapir Positron Emission Tomography (PET) Scan

    Florbetapir PET imaging was used to confirm the presence of amyloid pathology consistent with AD. Change from baseline was done to test the hypothesis that amyloid burden was reduced in participants in the treatment group. The change from baseline to the postbaseline visit of the composite summary standard uptake value ratio of florbetapir F18 was calculated. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. The composite summary measure is an unweighted average of the 6 smaller regions (anterior cingulate, frontal medial orbital, parietal, posterior cingulate, precuneus, and temporal) normalized to whole cerebellum or subject-specific white matter.

    Measured: Baseline, Week 80

  17. Change From Baseline in Cerebrospinal Fluid (CSF) Aβ Levels

    Concentration of CSF parameters includes amino acid peptide known as Aβ 1-42 and Aβ 1-42. Analyses of these CSF biomarkers was conducted in a subset of participants (as an addendum to the protocol). The dependent variable for each CSF parameter was its change from baseline to endpoint. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit.

    Measured: Baseline, Week 80

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionOct 2016
  4. Study completionFeb 2017

Why it stopped: Solanezumab did not meet the study's primary endpoint.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01900665
Sponsor's protocol ID
15136
Other IDs
H8A-MC-LZAX
Acronym
EXPEDITION 3
Status last verified
Sep 2019
First submitted
12 Jul 2013
Last updated
9 Oct 2019
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 40603145

  • 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.

    PubMed 36946603

  • 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.

    PubMed 29365294

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Solanezumab in people with Alzheimer's Disease, run by Eli Lilly and Company at 198 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 198 sites in United States, France, Japan, United Kingdom, Australia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 14 Item Subscore (ADAS-Cog14) (time frame: Baseline, Week 80). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01900665, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.

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