AzTrials
AzTrials

Alzheimer's DiseasePhase 3ExpeditionPRONCT02760602

A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease

A Phase 3 study testing Solanezumab in people with Alzheimer's Disease, run by Eli Lilly and Company at 193 sites in 13 countries.

Terminated

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

Official record
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Trial summary

The main purpose of this study is to investigate the safety and efficacy of the study drug solanezumab in participants with prodromal Alzheimer's disease (AD). Read more about this study

Who is it for?
Ages 55 to 85 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
26 participants
Where
193 sitesin 13 countries
Study dates
Jun 2016to May 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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has a diagnosis by the study investigator of a clinical syndrome of cognitive impairment consistent with prodromal AD per International Working Group (IWG) diagnostic criteria or mild cognitive impairment (MCI) due to AD per National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria.
  • Scores 17-28 on Montreal Cognitive Assessment (MoCA) at screening.
  • Scores <27 on free recall cutoff score from the Free and Cued Selective Reminding Test (FCSRT) (Picture version) at screening.
  • Scores ≤4 on Modified Hachinski Ischemia Scale (MHIS).
  • Scores >0 on the Functional Activities Questionnaire (FAQ).
  • Has a florbetapir positron emission tomography (PET) scan or cerebrospinal fluid (CSF) result at screening consistent with the presence of amyloid pathology.

Who cannot join

  • Has had MRI or computerized tomography (CT) of brain within previous 2 years showing pathology that would be inconsistent with a diagnosis of AD.
  • Has known allergy to humanized monoclonal antibodies.
  • Has an ongoing clinically significant laboratory abnormality, as determined by the investigator.
  • Has screening MRI with results showing >4 amyloid related imaging abnormalities H (ARIA-H) micro-hemorrhages or presence of ARIA-E.
  • Has any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI.
  • Has received treatment with a stable dose of an acetylcholinesterase (AChEI) inhibitor or memantine for less than 2 months before randomization. (If a participant has recently stopped AChEIs and/or memantine, he or she must have discontinued treatment at least 2 months before randomization.)

Trial locations and contacts

193 sites in 13 countries.

193 sites in 13 countries

United States98 sites

  • Abington Neurological Associates

    Abington, Pennsylvania, 19090

  • Albany Medical College

    Albany, New York, 12206

  • Lehigh Valley Hospital

    Allentown, Pennsylvania, 18103

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18104

  • Atlanta Center of Medical Research

    Atlanta, Georgia, 30331

  • Sheppard Pratt Health System

    Baltimore, Maryland, 21204

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21205

  • PharmaSite Research Inc

    Baltimore, Maryland, 21208

  • Sheppard Pratt Health System

    Baltimore, Maryland, 21285

  • The Memory Clinic

    Bennington, Vermont, 05201

  • ClinVest

    Bolivar, Missouri, 65613

  • Christie Clinic, LLC

    Champaign, Illinois, 61820

  • Alzheimer's Memory Center

    Charlotte, North Carolina, 28270

  • Clinical Research Professionals

    Chesterfield, Missouri, 63141

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • MCB Clinical Research Centers

    Colorado Springs, Colorado, 80910

  • Millenium Psychiatric Associates LLC

    Creve Coeur, Missouri, 63141

  • Baylor AT&T Memory Center

    Dallas, Texas, 75219

  • Baylor AT&T Memory Center

    Dallas, Texas, 75231

  • FutureSearch Trials

    Dallas, Texas, 75231

  • Neurology Diagnostics, Inc.

    Dayton, Ohio, 45459

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • Mile High Research Center

    Denver, Colorado, 80218

  • Rhode Island Mood & Memory Research Institute

    East Providence, Rhode Island, 02914

  • Memory Enhancement Center of America, Inc.

    Eatontown, New Jersey, 07724

  • Alexian Brothers Medical Center

    Elk Grove Village, Illinois, 60007

  • QUEST Research Institute

    Farmington Hills, Michigan, 48334

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, Florida, 33912

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana, 46804

  • United Osteoporosis Center

    Gainesville, Georgia, 30501

  • Parexel Early Phase Unit at Glendale

    Glendale, California, 91206-4140

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • Sunrise Clinical Research

    Hollywood, Florida, 33021

  • Houston Methodist

    Houston, Texas, 77030

  • University of Texas Health Services Center - Houston

    Houston, Texas, 77054

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • Josephson Wallack Munshower Neurology

    Indianapolis, Indiana, 46256

  • Clinical Neuroscience Solutions Inc

    Jacksonville, Florida, 32256

  • Clinical Trial Center, LLC, Psychiatry

    Jenkintown, Pennsylvania, 19046

  • St Lukes Hospital

    Kansas City, Missouri, 64111

  • Evergreen Professional Plaza

    Kirkland, Washington, 98034

  • Lake Charles Clinical Trials

    Lake Charles, Louisiana, 70629

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89113

  • Baptist Health Medical Group

    Lexington, Kentucky, 40503

  • ActivMed Practices & Research, Inc

    Methuen, Massachusetts, 01844

  • Miami Jewish Health Systems

    Miami, Florida, 33137

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Dean Foundation for Health Research and Education

    Middleton, Wisconsin, 53562

  • Pyramid Clinical Research

    Monroe, New Jersey, 08831

  • Healthy Perspectives Innovative Mental Health Services, PL

    Nashua, New Hampshire, 03060

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • Suncoast Clinical Research

    New Port Richey, Florida, 34652

  • Christiana Care Research Institute

    Newark, Delaware, 19713

  • Sentara Medical Group

    Norfolk, Virginia, 23510

  • Sensible Healthcare

    Ocoee, Florida, 34761

  • Metrolina Neurological Research Institute

    Old Point Station, South Carolina, 29707

  • Compass Research

    Orlando, Florida, 32806

  • Pacific Neuroscience Medical Group

    Oxnard, California, 93030

  • Pensacola Research Consultants, Inc.

    Pensacola, Florida, 32502

  • Xenoscience

    Phoenix, Arizona, 85004

  • Banner Alzheimer's Institute

    Phoenix, Arizona, 85006

  • St Josephs Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Northeastern Pennsylvania Memory & Alzheimer's Center

    Plains, Pennsylvania, 18705

  • Donald S Marks

    Plymouth, Massachusetts, 02360-4843

  • Quantum Laboratories

    Pompano Beach, Florida, 33064

  • Summit Research Network Inc

    Portland, Oregon, 97210

  • Center for Cognitive Health

    Portland, Oregon, 97225

  • ActivMed Practices & Research, Inc

    Portsmouth, New Hampshire, 03801

  • Princeton Medical Institute

    Princeton, New Jersey, 08540

  • Butler Hospital

    Providence, Rhode Island, 02906

  • Desert Valley Research

    Rancho Mirage, California, 92270

  • National Clinical Research - Richmond

    Richmond, Virginia, 23294

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • Univ of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Pacific Research Network Inc

    San Diego, California, 92103

  • Sharp Mesa Vista Hospital

    San Diego, California, 92123

  • California Pacific Medical Center

    San Francisco, California, 94114

  • Apex Research Institute

    Santa Ana, California, 92705

  • Care Access Research LLC

    Santa Clarita, California, 91321

  • Roskamp Institute

    Sarasota, Florida, 34243

  • Maine Neurology

    Scarborough, Maine, 04074

  • Insight Clinical Trials

    Shaker Heights, Ohio, 44122

  • California Neuroscience Research

    Sherman Oaks, California, 91403

  • The Cognitive and Research Center of NJ

    Springfield, New Jersey, 07081

  • New England Institute for Clinical Research

    Stamford, Connecticut, 06905

  • Richmond Behavorial Associates

    Staten Island, New York, 10312

  • Banner Sun Health Research Institute

    Sun City, Arizona, 85351

  • Axiom Research

    Tampa, Florida, 33609

  • Advanced Memory Research Institute of New Jersey

    Toms River, New Jersey, 08755

  • Bio Behavioral Health

    Toms River, New Jersey, 08755

  • Cotton O'Neil Clinic

    Topeka, Kansas, 66606

  • Center for Neurosciences

    Tucson, Arizona, 85718

  • Arizona Health Sciences Center

    Tucson, Arizona, 85724

  • Care Access Research

    Valencia, California, 91355

  • Premiere Research Institute at Palm Beach Neurology

    West Palm Beach, Florida, 33407

  • Heartland Research Associates

    Wichita, Kansas, 67207

  • Central DuPage Hospital

    Winfield, Illinois, 60190

  • Piedmont Medical Research

    Winston-Salem, North Carolina, 27103

Other trials in United States

Japan14 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.

    Bunkyō City, 113-8431

  • 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, 113-8655

  • 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.

    Hachiōji, 193-0998

  • 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, 673-0848

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    Kamakura, 247-8533

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    Kodaira-shi, 187-8551

  • 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.

    Kōriyama, 963-8052

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    Kyoto, 607-8113

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    Mitaka-shi, 181-0013

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    Shinjuku-Ku, 160-8582

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    Shizuoka, 424-0911

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    Takamatsu, 760-8557

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    Tokyo, 113-0034

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    Tsu, 514-8507

Other trials in Japan

France12 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.

    Amiens, 80054

  • 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.

    Bordeaux, 33076

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    Bron, 69677

  • 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.

    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, 75010

  • 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, 75015

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    Paris, 75651

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    Rennes, 35033

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    Strasbourg, 67000

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    Toulouse, 31059

Other trials in France

Spain12 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.

    Barcelona, 08014

  • 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.

    Barcelona, 08025

  • 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.

    Barcelona, 08036

  • 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.

    Castellon, 12004

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    Donostia / San Sebastian, 20009

  • 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.

    Getafe, 28905

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    Getxo, 48993

  • 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.

    Madrid, 28006

  • 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.

    Plasencia, 10600

  • 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.

    Salt, 17190

  • 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.

    Valencia, 46017

  • 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.

    Valencia, 46026

Other trials in Spain

Italy11 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.

    Genova, 16132

  • 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

  • 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, 20133

  • 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.

    Monza, 20052

  • 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.

    Pavia, 27100

  • 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.

    Perugia, 06134

  • 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.

    Pisa, 56126

  • 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.

    Roma, 00153

  • 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.

    Roma, 00161

  • 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.

    Roma, 00179

  • 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.

    Roma, 00189

Other trials in Italy

Canada9 sites

  • 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.

    Gatineau, J8T 8J1

  • 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.

    Greenfield Park, J4V 2J2

  • 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.

    Halifax, B3S1M7

  • 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.

    Kentville, B4N 4K9

  • 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, N6C 0A7

  • 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.

    Ottawa, KIN 5C8

  • 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.

    Peterborough, K9H2P4

  • 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.

    Sherbrooke, J1H1Z1

  • 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, M3B 2S7

Other trials in Canada

Taiwan9 sites

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    Changhua, 500

  • 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.

    Gwei Shan Township, 333

  • 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.

    Kaohsiung City, 80756

  • 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.

    Kaohsiung City, 83301

  • 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.

    Taichung, 40447

  • 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.

    Tainan, 70403

  • 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.

    Taipei, 10048

  • 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.

    Taipei, 11217

  • 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.

    Zhonghe, 235

Other trials in Taiwan

Poland6 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.

    Bialystok, 15-732

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    Bydgoszcz, 85-796

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    Lublin, 20-093

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    Poznan, 30-856

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    Sopot, 81-824

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    Warsaw, 01-697

Other trials in Poland

Puerto Rico6 sites

  • Santa Cruz Behavioral PSC

    Bayamón, 00961-6911

  • Cortex, PSC

    Las Piedras, 00771

  • University Of Puerto Rico

    Rio Piedras, 00936

  • Instituto de Neurologia Dra. Ivonne Fraga

    San Juan, 00918

  • Latin Clinical Trial Center

    San Juan, 00918

  • SomniCare Sleep Institute

    San Juan, 00918

Other trials in Puerto Rico

United Kingdom6 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, BA1 3NG

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    Chelsea, W6 8RF

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    Guildford, GU2 7YD

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    London, W1G 9RU

  • 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.

    Manchester, M13 9WL

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    Scotland, G20 0XA

Other trials in United Kingdom

Finland5 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.

    Kuopio, 70210

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    Oulu, 90100

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    Tampere, 33100

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    Turku, 20014

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    Vaasa, 65130

Other trials in Finland

Sweden4 sites

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    Malmö, 20502

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    Mölndal, 43141

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    Stockholm, 113 61

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    Umeå, 90105

Other trials in Sweden

Germany1 site

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    Chemnitz, 09131

Other trials in Germany

About this study

Official title: A 24-Month, Phase 3, Multicenter, Placebo-Controlled Study of Efficacy and Safety of Solanezumab Versus Placebo in Prodromal Alzheimer's Disease

The main purpose of this study is to investigate the safety and efficacy of the study drug solanezumab in participants with prodromal Alzheimer's disease (AD).

Being tested
Solanezumab, Placebo
Keywords
anti-amyloid, monoclonal antibody
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

    Administered IV

  • PlaceboDrug

    Administered IV

Study groups in NCT02760602
Study groupRoleWhat they receive
SolanezumabExperimentalSolanezumab given intravenously (IV) once every 4 weeks for up to 2 years.
Receives: Drug: Solanezumab
PlaceboExperimentalPlacebo given IV once every 4 weeks for up to 2 years.
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 Subscale (ADAS-Cog14) Score

    ADAS-Cog14 is ADAS-Cog11 augmented with 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.

    Measured: Baseline, 24 Months

Secondary outcomes (16)

  1. Change From Baseline on Alzheimer´s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL)

    The ADCS-MCI-ADL is a functional evaluation scale for MCI patients, based on information provided by an informant that describes the performance of participants in several ADLs. Total score ranges from 0 to 69; lower score indicates greater disease severity.

    Measured: Baseline, 24 Months

  2. Change From Baseline on the Mini Mental Status 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.

    Measured: Baseline, 24 Months

  3. Change From Baseline on the Montreal Cognitive Assessment (MoCA)

    The MoCA will be used as the global cognitive screening instrument. It will also be administered in the clinical trial at baseline and the final visits of each phase as a secondary outcome measure of global cognition. Scores on the MoCA range from 0-30 with 26-30 indicating normal global cognition.

    Measured: Baseline, 24 Months

  4. Change From Baseline on the 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 Writing checks, Assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, Traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now = 1; Never did [the activity] but could do now = 0; Normal = 0; Has difficulty but does by self = 1; Requires assistance = 2; Dependent = 3). The maximum FAQ total score is 30, with higher scores indicating greater impairment.

    Measured: Baseline, 24 Months

  5. Change From Baseline on the Neuropsychiatric Inventory (NPI)

    The NPI is a tool for assessing psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant's behavior. The score ranges from 12 to 144, with higher scores indicating greater disease severity.

    Measured: Baseline, 24 Months

  6. Change From Baseline on the Clinical Dementia Rating Scale 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.

    Measured: Baseline, 24 Months

  7. Change From Baseline on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

    RBANS is a brief neurocognitive battery with four alternate forms, measuring immediate and delayed memory, attention, language, and visuospatial/constructional skills.

    Measured: Baseline, 24 Months

  8. Change From Baseline on the Free and Cued Selective Reminding Test (FCSRT)

    The FCSRT is a neuropsychological test of memory under conditions that control attention and cognitive processing in order to obtain an assessment of memory unconfounded by normal age-related changes in cognition.

    Measured: Baseline, 24 Months

  9. Change From Baseline on the Resource Utilization in Dementia-Lite (RUD-Lite)

    RUD-Lite assesses the healthcare resource utilization of participants and their caregivers to determine the level of formal and informal care attributable to Alzheimer's Disease (AD). Information on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) is collected from the baseline and follow-up interviews.

    Measured: Baseline, 24 Months

  10. Change From Baseline on the EuroQol 5-Dimensional Health-Related Quality of Life Scale (EQ-5D)

    EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Visual analogue scale (VAS) assesses caregiver's impression of participant's overall health state; scores range: 0 to 100. Lower scores indicate greater disease severity.

    Measured: Baseline, 24 Months

  11. Change From Baseline on the Quality of Life in Alzheimer's Disease Scale (QoL-AD)

    QoL for AD assess 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: 13-52). Higher scores=greater QoL.

    Measured: Baseline, 24 Months

  12. Change From Baseline in Concentration of Plasma Amyloid-β Peptide (Aβ) and Plasma Solanezumab

    Concentration of amino acid peptide known as Aβ 1-42 in plasma.

    Measured: Baseline, 24 Months

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

    MRI will be used to assess the effect of treatment on rate of whole brain volume.

    Measured: Baseline, 24 Months

  14. Change From Baseline in Florbetapir Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVr)

    Florbetapir F18 PET used to assess the treatment effect in brain amyloid plaque deposition from baseline through 18 months as measured by florbetapir F18 PET Standardized Uptake Uptake Value ratio.

    Measured: Baseline, 24 Months

  15. Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Aβ and CSF Tau Proteins

    Changes in CSF parameters, including total and free Aβ1-40 and Aβ1-42 species and total tau and P-tau181 peptides, will be assessed.

    Measured: Baseline, 24 Months

  16. Change From Baseline in Neocortical Tau Deposits Using 18F-AV-1451 PET

    Biomarker change will be analyzed to provide biomarker-based evidence that solanezumab affects the underlying disease pathology.

    Measured: Baseline, 24 Months

Timeline

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

  1. First posted3 May 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionMay 2017
  4. Study completionMay 2017

Why it stopped: Insufficient scientific evidence that solanezumab would likely demonstrate a meaningful benefit to participants with prodromal AD as defined by study protocol.

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02760602
Sponsor's protocol ID
16349
Other IDs
H8A-MC-LZBE, 2016-000108-27, 2016
Acronym
ExpeditionPRO
Status last verified
Sep 2019
First submitted
2 May 2016
Last updated
10 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.

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 193 sites in 13 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 6 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 10 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 193 sites in United States, Japan, France, Spain, Italy and 8 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. 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 24 Jul 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 Subscale (ADAS-Cog14) Score (time frame: Baseline, 24 Months). 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 NCT02760602.

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 10 Oct 2019.

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