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

2019년 9월 25일 업데이트: Eli Lilly and Company

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).

연구 개요

상태

종료됨

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

26

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 대만
      • Changhua, 대만, 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, 대만, 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.
      • Jhonghe City, 대만, 235
        • 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, 대만, 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, 대만, 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, 대만, 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, 대만, 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, 대만, 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, 대만, 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.
  • 독일
      • Chemnitz, 독일, 09131
        • 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.
  • 미국
    • Arizona
      • Phoenix, Arizona, 미국, 85006
        • Banner Alzheimer's Institute
      • Phoenix, Arizona, 미국, 85013
        • St Josephs Hospital and Medical Center
      • Phoenix, Arizona, 미국, 85004
        • Xenoscience
      • Sun City, Arizona, 미국, 85351
        • Banner Sun Health Research Institute
      • Tucson, Arizona, 미국, 85718
        • Center for Neurosciences
      • Tucson, Arizona, 미국, 85724
        • Arizona Health Sciences Center
    • California
      • Glendale, California, 미국, 91206-4140
        • Parexel Early Phase Unit at Glendale
      • Oxnard, California, 미국, 93030
        • Pacific Neuroscience Medical Group
      • Rancho Mirage, California, 미국, 92270
        • Desert Valley Research
      • San Diego, California, 미국, 92123
        • Sharp Mesa Vista Hospital
      • San Diego, California, 미국, 92103
        • Pacific Research Network Inc
      • San Francisco, California, 미국, 94114
        • California Pacific Medical Center
      • Santa Ana, California, 미국, 92705
        • Apex Research Institute
      • Santa Clarita, California, 미국, 91321
        • Care Access Research LLC
      • Sherman Oaks, California, 미국, 91403
        • California Neuroscience Research
      • Valencia, California, 미국, 91355
        • Care Access Research
    • Colorado
      • Colorado Springs, Colorado, 미국, 80910
        • MCB Clinical Research Centers
      • Denver, Colorado, 미국, 80218
        • Mile High Research Center
    • Connecticut
      • New Haven, Connecticut, 미국, 06510
        • Yale University School of Medicine
      • Stamford, Connecticut, 미국, 06905
        • New England Institute for Clinical Research
    • Delaware
      • Newark, Delaware, 미국, 19713
        • Christiana Care Research Institute
    • Florida
      • Delray Beach, Florida, 미국, 33445
        • Brain Matters Research
      • Fort Myers, Florida, 미국, 33912
        • Neuropsychiatric Research Center of Southwest Florida
      • Hollywood, Florida, 미국, 33021
        • Sunrise Clinical Research
      • Jacksonville, Florida, 미국, 32256
        • Clinical NeuroScience Solutions Inc
      • Miami, Florida, 미국, 33137
        • Miami Jewish Health Systems
      • Miami Beach, Florida, 미국, 33140
        • Mount Sinai Medical Center
      • New Port Richey, Florida, 미국, 34652
        • Suncoast Clinical Research
      • Ocoee, Florida, 미국, 34761
        • Sensible Healthcare
      • Orlando, Florida, 미국, 32806
        • Compass Research
      • Pensacola, Florida, 미국, 32502
        • Pensacola Research Consultants, Inc.
      • Pompano Beach, Florida, 미국, 33064
        • Quantum Laboratories
      • Sarasota, Florida, 미국, 34243
        • Roskamp Institute
      • Tampa, Florida, 미국, 33609
        • Axiom Research
      • West Palm Beach, Florida, 미국, 33407
        • Premiere Research Institute at Palm Beach Neurology
    • Georgia
      • Atlanta, Georgia, 미국, 30331
        • Atlanta Center of Medical Research
      • Gainesville, Georgia, 미국, 30501
        • United Osteoporosis Center
    • Illinois
      • Champaign, Illinois, 미국, 61820
        • Christie Clinic, LLC
      • Elk Grove Village, Illinois, 미국, 60007
        • Alexian Brothers Medical Center
      • Winfield, Illinois, 미국, 60190
        • Central DuPage Hospital
    • Indiana
      • Fort Wayne, Indiana, 미국, 46804
        • Fort Wayne Neurological Center
      • Indianapolis, Indiana, 미국, 46202
        • Indiana University School of Medicine
      • Indianapolis, Indiana, 미국, 46256
        • Josephson Wallack Munshower Neurology
    • Kansas
      • Topeka, Kansas, 미국, 66606
        • Cotton O'Neil Clinic
      • Wichita, Kansas, 미국, 67207
        • Heartland Research Associates
    • Kentucky
      • Lexington, Kentucky, 미국, 40503
        • Baptist Health Medical Group
    • Louisiana
      • Lake Charles, Louisiana, 미국, 70629
        • Lake Charles Clinical Trials
    • Maine
      • Scarborough, Maine, 미국, 04074
        • Maine Neurology
    • Maryland
      • Baltimore, Maryland, 미국, 21285
        • Sheppard Pratt Health System
      • Baltimore, Maryland, 미국, 21204
        • Sheppard Pratt Health System
      • Baltimore, Maryland, 미국, 21205
        • Johns Hopkins University School of Medicine
      • Baltimore, Maryland, 미국, 21208
        • Pharmasite Research Inc
    • Massachusetts
      • Methuen, Massachusetts, 미국, 01844
        • ActivMed Practices & Research, Inc
      • Plymouth, Massachusetts, 미국, 02360-4843
        • Donald S Marks
    • Michigan
      • Farmington Hills, Michigan, 미국, 48334
        • QUEST Research Institute
    • Mississippi
      • Hattiesburg, Mississippi, 미국, 39401
        • Hattiesburg Clinic
    • Missouri
      • Bolivar, Missouri, 미국, 65613
        • Clinvest
      • Chesterfield, Missouri, 미국, 63141
        • Clinical Research Professionals
      • Creve Coeur, Missouri, 미국, 63141
        • Millenium Psychiatric Associates LLC
      • Kansas City, Missouri, 미국, 64111
        • St Lukes Hospital
    • Nevada
      • Las Vegas, Nevada, 미국, 89113
        • Las Vegas Medical Research
    • New Hampshire
      • Nashua, New Hampshire, 미국, 03060
        • Healthy Perspectives Innovative Mental Health Services, PL
      • Portsmouth, New Hampshire, 미국, 03801
        • ActivMed Practices & Research, Inc
    • New Jersey
      • Eatontown, New Jersey, 미국, 07724
        • Memory Enhancement Center of America, Inc.
      • Monroe, New Jersey, 미국, 08831
        • Pyramid Clinical Research
      • Princeton, New Jersey, 미국, 08540
        • Princeton Medical Institute
      • Springfield, New Jersey, 미국, 07081
        • The Cognitive and Research Center of NJ
      • Toms River, New Jersey, 미국, 08755
        • Advanced Memory Research Institute of New Jersey
      • Toms River, New Jersey, 미국, 08755
        • Bio Behavioral Health
    • New York
      • Albany, New York, 미국, 12206
        • Albany Medical College
      • Staten Island, New York, 미국, 10312
        • Richmond Behavorial Associates
    • North Carolina
      • Charlotte, North Carolina, 미국, 28270
        • Alzheimer's Memory Center
      • Winston-Salem, North Carolina, 미국, 27103
        • Piedmont Medical Research
    • Ohio
      • Cincinnati, Ohio, 미국, 45219
        • University of Cincinnati Medical Center
      • Dayton, Ohio, 미국, 45459
        • Neurology Diagnostics, Inc.
      • Shaker Heights, Ohio, 미국, 44122
        • Insight Clinical Trials
    • Oregon
      • Portland, Oregon, 미국, 97225
        • Center for Cognitive Health
      • Portland, Oregon, 미국, 97210
        • Summit Research Network Inc
    • Pennsylvania
      • Abington, Pennsylvania, 미국, 19090
        • Abington Neurological Associates
      • Allentown, Pennsylvania, 미국, 18104
        • Lehigh Center for Clinical Research
      • Allentown, Pennsylvania, 미국, 18103
        • Lehigh Valley Hospital
      • Jenkintown, Pennsylvania, 미국, 19046
        • Clinical Trial Center, LLC, Psychiatry
      • Plains, Pennsylvania, 미국, 18705
        • Northeastern Pennsylvania Memory & Alzheimer's Center
    • Rhode Island
      • East Providence, Rhode Island, 미국, 02914
        • Rhode Island Mood & Memory Research Institute
      • Providence, Rhode Island, 미국, 02906
        • Butler Hospital
    • South Carolina
      • Indian Land, South Carolina, 미국, 29707
        • Metrolina Neurological Research Institute
    • Texas
      • Dallas, Texas, 미국, 75231
        • FutureSearch Trials
      • Dallas, Texas, 미국, 75231
        • Baylor AT&T Memory Center
      • Dallas, Texas, 미국, 75219
        • Baylor AT&T Memory Center
      • Houston, Texas, 미국, 77030
        • Houston Methodist
      • Houston, Texas, 미국, 77054
        • University of Texas Health Services Center - Houston
      • San Antonio, Texas, 미국, 78229
        • Clinical Trials of Texas, Inc.
      • San Antonio, Texas, 미국, 78229
        • Univ of Texas Health Science Center at San Antonio
    • Vermont
      • Bennington, Vermont, 미국, 05201
        • The Memory Clinic
    • Virginia
      • Norfolk, Virginia, 미국, 23510
        • Sentara Medical Group
      • Richmond, Virginia, 미국, 23294
        • National Clinical Research - Richmond
    • Washington
      • Kirkland, Washington, 미국, 98034
        • Evergreen Professional Plaza
    • Wisconsin
      • Middleton, Wisconsin, 미국, 53562
        • Dean Foundation for Health Research and Education
  • 스웨덴
      • Malmö, 스웨덴, 20502
        • 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.
      • Mölndal, 스웨덴, 43141
        • 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.
      • Stockholm, 스웨덴, 113 61
        • 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.
      • Umeå, 스웨덴, 90105
        • 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.
  • 스페인
      • Barcelona, 스페인, 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, 스페인, 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.
      • Barcelona, 스페인, 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.
      • Castellon de la Plana, 스페인, 12004
        • 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, 스페인, 28905
        • 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.
      • Getxo, 스페인, 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, 스페인, 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, 스페인, 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, 스페인, 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.
      • San Sebastian, 스페인, 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.
      • Valencia, 스페인, 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, 스페인, 46026
        • 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.
  • 영국
      • Bath, 영국, BA1 3NG
        • 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.
      • Chelsea, 영국, W6 8RF
        • 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.
      • Guildford, 영국, GU2 7YD
        • 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, 영국, 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, 영국, M13 9WL
        • 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, 영국, 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.
  • 이탈리아
      • Genova, 이탈리아, 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.
      • Milano, 이탈리아, 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.
      • Milano, 이탈리아, 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, 이탈리아, 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, 이탈리아, 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, 이탈리아, 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, 이탈리아, 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, 이탈리아, 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, 이탈리아, 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, 이탈리아, 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, 이탈리아, 00189
        • 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.
  • 일본
      • Bunkyo-ku, 일본, 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.
      • Bunkyo-ku, 일본, 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.
      • Hachioji, 일본, 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.
      • Hyogo, 일본, 673-0848
        • 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.
      • Kamakura, 일본, 247-8533
        • 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.
      • Kodaira-shi, 일본, 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.
      • Koriyama, 일본, 963-8052
        • 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.
      • Kyoto-shi, 일본, 607-8113
        • 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.
      • Mitaka-shi, 일본, 181-0013
        • 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.
      • Shinjuku-Ku, 일본, 160-8582
        • 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.
      • Shizuoka, 일본, 424-0911
        • 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.
      • Takamatsu, 일본, 760-8557
        • 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.
      • Tokyo, 일본, 113-0034
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      • Tsu-shi, 일본, 514-8507
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  • 캐나다
      • Gatineau, 캐나다, 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, 캐나다, 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, 캐나다, 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, 캐나다, 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, 캐나다, 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, 캐나다, 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, 캐나다, 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, 캐나다, 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, 캐나다, M3B 2S7
        • 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.
  • 폴란드
      • Białystok, 폴란드, 15-732
        • 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.
      • Bydgoszcz, 폴란드, 85-796
        • 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.
      • Lublin, 폴란드, 20-093
        • 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.
      • Poznan, 폴란드, 30-856
        • 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.
      • Sopot, 폴란드, 81-824
        • 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.
      • Warszawa, 폴란드, 01-697
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  • 푸에르토 리코
      • Bayamón, 푸에르토 리코, 00961-6911
        • Santa Cruz Behavioral PSC
      • Las Piedras, 푸에르토 리코, 00771
        • Cortex, PSC
      • Rio Piedras, 푸에르토 리코, 00936
        • University of Puerto Rico
      • San Juan, 푸에르토 리코, 00918
        • Instituto De Neurologia Dra. Ivonne Fraga
      • San Juan, 푸에르토 리코, 00918
        • SomniCare Sleep Institute
      • San Juan, 푸에르토 리코, 00918
        • Latin Clinical Trial Center
  • 프랑스
      • Amiens, 프랑스, 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, 프랑스, 33076
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      • Bron, 프랑스, 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, 프랑스, 59037
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      • Marseille, 프랑스, 13385
        • 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.
      • Montpellier, 프랑스, 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, 프랑스, 75015
        • 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, 프랑스, 75651
        • 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, 프랑스, 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.
      • Rennes, 프랑스, 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, 프랑스, 67000
        • 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, 프랑스, 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.
  • 핀란드
      • Kuopio, 핀란드, 70210
        • 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.
      • Oulu, 핀란드, 90100
        • 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.
      • Tampere, 핀란드, 33100
        • 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.
      • Turku, 핀란드, 20014
        • 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.
      • Vaasa, 핀란드, 65130
        • 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.

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

55년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Solanezumab
Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.
의약품: 솔라네주맙
IV 투여
다른 이름들:
  • LY2062430
실험적: Placebo
Placebo given IV once every 4 weeks for up to 2 years.
의약품: 위약
IV 투여

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score
기간: Baseline, 24 Months
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.
Baseline, 24 Months

2차 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline on Alzheimer´s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL)
기간: Baseline, 24 Months
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.
Baseline, 24 Months
Change From Baseline on the Mini Mental Status Examination (MMSE)
기간: Baseline, 24 Months
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.
Baseline, 24 Months
Change From Baseline on the Montreal Cognitive Assessment (MoCA)
기간: Baseline, 24 Months
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.
Baseline, 24 Months
Change From Baseline on the Functional Activities Questionnaire (FAQ)
기간: Baseline, 24 Months
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.
Baseline, 24 Months
Change From Baseline on the Neuropsychiatric Inventory (NPI)
기간: Baseline, 24 Months
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.
Baseline, 24 Months
Change From Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)
기간: Baseline, 24 Months
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.
Baseline, 24 Months
Change From Baseline on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
기간: Baseline, 24 Months
RBANS is a brief neurocognitive battery with four alternate forms, measuring immediate and delayed memory, attention, language, and visuospatial/constructional skills.
Baseline, 24 Months
Change From Baseline on the Free and Cued Selective Reminding Test (FCSRT)
기간: Baseline, 24 Months
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.
Baseline, 24 Months
Change From Baseline on the Resource Utilization in Dementia-Lite (RUD-Lite)
기간: Baseline, 24 Months
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.
Baseline, 24 Months
Change From Baseline on the EuroQol 5-Dimensional Health-Related Quality of Life Scale (EQ-5D)
기간: Baseline, 24 Months
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.
Baseline, 24 Months
Change From Baseline on the Quality of Life in Alzheimer's Disease Scale (QoL-AD)
기간: Baseline, 24 Months
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.
Baseline, 24 Months
Change From Baseline in Concentration of Plasma Amyloid-β Peptide (Aβ) and Plasma Solanezumab
기간: Baseline, 24 Months
Concentration of amino acid peptide known as Aβ 1-42 in plasma.
Baseline, 24 Months
Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI)
기간: Baseline, 24 Months
MRI will be used to assess the effect of treatment on rate of whole brain volume.
Baseline, 24 Months
Change From Baseline in Florbetapir Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVr)
기간: Baseline, 24 Months
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.
Baseline, 24 Months
Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Aβ and CSF Tau Proteins
기간: Baseline, 24 Months
Changes in CSF parameters, including total and free Aβ1-40 and Aβ1-42 species and total tau and P-tau181 peptides, will be assessed.
Baseline, 24 Months
Change From Baseline in Neocortical Tau Deposits Using 18F-AV-1451 PET
기간: Baseline, 24 Months
Biomarker change will be analyzed to provide biomarker-based evidence that solanezumab affects the underlying disease pathology.
Baseline, 24 Months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Eli Lilly and Company

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2016년 6월 1일

기본 완료 (실제)

2017년 5월 1일

연구 완료 (실제)

2017년 5월 1일

연구 등록 날짜

최초 제출

2016년 5월 2일

QC 기준을 충족하는 최초 제출

2016년 5월 2일

처음 게시됨 (추정)

2016년 5월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 10월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 9월 25일

마지막으로 확인됨

2019년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 16349
  • H8A-MC-LZBE (기타 식별자: Eli Lilly and Company)
  • 2016-000108-27 (EudraCT 번호)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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.

IPD 공유 기간

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.

IPD 공유 액세스 기준

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • CSR

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

알츠하이머병에 대한 임상 시험

위약에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Gambia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다