A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease (ExpeditionPRO)
25. september 2019 opdateret af: 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).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
26
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Gatineau, Canada, 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.
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Greenfield Park, Canada, J4V 2J2
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Halifax, Canada, B3S1M7
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Kentville, Canada, B4N 4K9
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London, Canada, N6C 0A7
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Ottawa, Canada, KIN 5C8
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Peterborough, Canada, K9H2P4
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Sherbrooke, Canada, J1H1Z1
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Toronto, Canada, M3B 2S7
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Bath, Det Forenede Kongerige, BA1 3NG
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Chelsea, Det Forenede Kongerige, W6 8RF
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Guildford, Det Forenede Kongerige, GU2 7YD
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London, Det Forenede Kongerige, W1G 9RU
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Manchester, Det Forenede Kongerige, M13 9WL
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Scotland, Det Forenede Kongerige, G20 0XA
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Kuopio, Finland, 70210
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Oulu, Finland, 90100
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Tampere, Finland, 33100
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Turku, Finland, 20014
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Vaasa, Finland, 65130
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Arizona
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Phoenix, Arizona, Forenede Stater, 85006
- Banner Alzheimer's Institute
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Phoenix, Arizona, Forenede Stater, 85013
- St Josephs Hospital and Medical Center
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Phoenix, Arizona, Forenede Stater, 85004
- Xenoscience
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Sun City, Arizona, Forenede Stater, 85351
- Banner Sun Health Research Institute
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Tucson, Arizona, Forenede Stater, 85718
- Center For Neurosciences
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Tucson, Arizona, Forenede Stater, 85724
- Arizona Health Sciences Center
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California
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Glendale, California, Forenede Stater, 91206-4140
- Parexel Early Phase Unit at Glendale
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Oxnard, California, Forenede Stater, 93030
- Pacific Neuroscience Medical Group
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Rancho Mirage, California, Forenede Stater, 92270
- Desert Valley Research
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San Diego, California, Forenede Stater, 92123
- Sharp Mesa Vista Hospital
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San Diego, California, Forenede Stater, 92103
- Pacific Research Network Inc
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San Francisco, California, Forenede Stater, 94114
- California Pacific Medical Center
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Santa Ana, California, Forenede Stater, 92705
- Apex Research Institute
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Santa Clarita, California, Forenede Stater, 91321
- Care Access Research LLC
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Sherman Oaks, California, Forenede Stater, 91403
- California Neuroscience Research
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Valencia, California, Forenede Stater, 91355
- Care Access Research
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Colorado
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Colorado Springs, Colorado, Forenede Stater, 80910
- MCB Clinical Research Centers
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Denver, Colorado, Forenede Stater, 80218
- Mile High Research Center
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06510
- Yale University School of Medicine
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Stamford, Connecticut, Forenede Stater, 06905
- New England Institute for Clinical Research
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Delaware
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Newark, Delaware, Forenede Stater, 19713
- Christiana Care Research Institute
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Florida
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Delray Beach, Florida, Forenede Stater, 33445
- Brain Matters Research
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Fort Myers, Florida, Forenede Stater, 33912
- Neuropsychiatric Research Center of Southwest Florida
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Hollywood, Florida, Forenede Stater, 33021
- Sunrise Clinical Research
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Jacksonville, Florida, Forenede Stater, 32256
- Clinical NeuroScience Solutions Inc
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Miami, Florida, Forenede Stater, 33137
- Miami Jewish Health Systems
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Miami Beach, Florida, Forenede Stater, 33140
- Mount Sinai Medical Center
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New Port Richey, Florida, Forenede Stater, 34652
- Suncoast Clinical Research
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Ocoee, Florida, Forenede Stater, 34761
- Sensible Healthcare
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Orlando, Florida, Forenede Stater, 32806
- Compass Research
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Pensacola, Florida, Forenede Stater, 32502
- Pensacola Research Consultants, Inc.
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Pompano Beach, Florida, Forenede Stater, 33064
- Quantum Laboratories
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Sarasota, Florida, Forenede Stater, 34243
- Roskamp Institute
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Tampa, Florida, Forenede Stater, 33609
- Axiom Research
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West Palm Beach, Florida, Forenede Stater, 33407
- Premiere Research Institute at Palm Beach Neurology
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Georgia
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Atlanta, Georgia, Forenede Stater, 30331
- Atlanta Center of Medical Research
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Gainesville, Georgia, Forenede Stater, 30501
- United Osteoporosis Center
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Illinois
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Champaign, Illinois, Forenede Stater, 61820
- Christie Clinic, LLC
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Elk Grove Village, Illinois, Forenede Stater, 60007
- Alexian Brothers Medical Center
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Winfield, Illinois, Forenede Stater, 60190
- Central DuPage Hospital
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Indiana
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Fort Wayne, Indiana, Forenede Stater, 46804
- Fort Wayne Neurological Center
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Indianapolis, Indiana, Forenede Stater, 46202
- Indiana University School of Medicine
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Indianapolis, Indiana, Forenede Stater, 46256
- Josephson Wallack Munshower Neurology
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Kansas
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Topeka, Kansas, Forenede Stater, 66606
- Cotton O'Neil Clinic
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Wichita, Kansas, Forenede Stater, 67207
- Heartland Research Associates
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40503
- Baptist Health Medical Group
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Louisiana
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Lake Charles, Louisiana, Forenede Stater, 70629
- Lake Charles Clinical Trials
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Maine
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Scarborough, Maine, Forenede Stater, 04074
- Maine Neurology
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Maryland
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Baltimore, Maryland, Forenede Stater, 21285
- Sheppard Pratt Health System
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Baltimore, Maryland, Forenede Stater, 21204
- Sheppard Pratt Health System
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Baltimore, Maryland, Forenede Stater, 21205
- Johns Hopkins University School of Medicine
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Baltimore, Maryland, Forenede Stater, 21208
- Pharmasite Research Inc
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Massachusetts
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Methuen, Massachusetts, Forenede Stater, 01844
- ActivMed Practices & Research, Inc
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Plymouth, Massachusetts, Forenede Stater, 02360-4843
- Donald S Marks
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Michigan
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Farmington Hills, Michigan, Forenede Stater, 48334
- Quest Research Institute
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Mississippi
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Hattiesburg, Mississippi, Forenede Stater, 39401
- Hattiesburg Clinic
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Missouri
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Bolivar, Missouri, Forenede Stater, 65613
- Clinvest
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Chesterfield, Missouri, Forenede Stater, 63141
- Clinical Research Professionals
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Creve Coeur, Missouri, Forenede Stater, 63141
- Millenium Psychiatric Associates LLC
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Kansas City, Missouri, Forenede Stater, 64111
- St Lukes Hospital
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89113
- Las Vegas Medical Research
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New Hampshire
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Nashua, New Hampshire, Forenede Stater, 03060
- Healthy Perspectives Innovative Mental Health Services, PL
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Portsmouth, New Hampshire, Forenede Stater, 03801
- ActivMed Practices & Research, Inc
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New Jersey
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Eatontown, New Jersey, Forenede Stater, 07724
- Memory Enhancement Center of America, Inc.
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Monroe, New Jersey, Forenede Stater, 08831
- Pyramid Clinical Research
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Princeton, New Jersey, Forenede Stater, 08540
- Princeton Medical Institute
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Springfield, New Jersey, Forenede Stater, 07081
- The Cognitive and Research Center of NJ
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Toms River, New Jersey, Forenede Stater, 08755
- Advanced Memory Research Institute of New Jersey
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Toms River, New Jersey, Forenede Stater, 08755
- Bio Behavioral Health
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New York
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Albany, New York, Forenede Stater, 12206
- Albany Medical College
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Staten Island, New York, Forenede Stater, 10312
- Richmond Behavorial Associates
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28270
- Alzheimer's Memory Center
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Winston-Salem, North Carolina, Forenede Stater, 27103
- Piedmont Medical Research
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45219
- University of Cincinnati Medical Center
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Dayton, Ohio, Forenede Stater, 45459
- Neurology Diagnostics, Inc.
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Shaker Heights, Ohio, Forenede Stater, 44122
- Insight Clinical Trials
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Oregon
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Portland, Oregon, Forenede Stater, 97225
- Center for Cognitive Health
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Portland, Oregon, Forenede Stater, 97210
- Summit Research Network Inc
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Pennsylvania
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Abington, Pennsylvania, Forenede Stater, 19090
- Abington Neurological Associates
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Allentown, Pennsylvania, Forenede Stater, 18104
- Lehigh Center for Clinical Research
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Allentown, Pennsylvania, Forenede Stater, 18103
- Lehigh Valley Hospital
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Jenkintown, Pennsylvania, Forenede Stater, 19046
- Clinical Trial Center, LLC, Psychiatry
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Plains, Pennsylvania, Forenede Stater, 18705
- Northeastern Pennsylvania Memory & Alzheimer's Center
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Rhode Island
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East Providence, Rhode Island, Forenede Stater, 02914
- Rhode Island Mood & Memory Research Institute
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Providence, Rhode Island, Forenede Stater, 02906
- Butler Hospital
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South Carolina
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Indian Land, South Carolina, Forenede Stater, 29707
- Metrolina Neurological Research Institute
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Texas
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Dallas, Texas, Forenede Stater, 75231
- FutureSearch Trials
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Dallas, Texas, Forenede Stater, 75231
- Baylor AT&T Memory Center
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Dallas, Texas, Forenede Stater, 75219
- Baylor AT&T Memory Center
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Houston, Texas, Forenede Stater, 77030
- Houston Methodist
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Houston, Texas, Forenede Stater, 77054
- University of Texas Health Services Center - Houston
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San Antonio, Texas, Forenede Stater, 78229
- Clinical Trials of Texas, Inc.
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San Antonio, Texas, Forenede Stater, 78229
- Univ of Texas Health Science Center at San Antonio
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Vermont
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Bennington, Vermont, Forenede Stater, 05201
- The Memory Clinic
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Virginia
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Norfolk, Virginia, Forenede Stater, 23510
- Sentara Medical Group
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Richmond, Virginia, Forenede Stater, 23294
- National Clinical Research - Richmond
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Washington
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Kirkland, Washington, Forenede Stater, 98034
- Evergreen Professional Plaza
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Wisconsin
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Middleton, Wisconsin, Forenede Stater, 53562
- Dean Foundation for Health Research and Education
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Amiens, Frankrig, 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.
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Bordeaux, Frankrig, 33076
- 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.
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Bron, Frankrig, 69677
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Lille, Frankrig, 59037
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Marseille, Frankrig, 13385
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Montpellier, Frankrig, 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.
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Paris, Frankrig, 75015
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Paris, Frankrig, 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.
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Paris, Frankrig, 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.
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Rennes, Frankrig, 35033
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Strasbourg, Frankrig, 67000
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Toulouse, Frankrig, 31059
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Genova, Italien, 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.
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Milano, Italien, 20122
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Milano, Italien, 20133
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Monza, Italien, 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.
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Pavia, Italien, 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.
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Perugia, Italien, 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.
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Pisa, Italien, 56126
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Roma, Italien, 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.
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Roma, Italien, 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.
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Roma, Italien, 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.
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Roma, Italien, 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.
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Bunkyo-ku, Japan, 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.
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Bunkyo-ku, Japan, 113-8431
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Hachioji, Japan, 193-0998
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Hyogo, Japan, 673-0848
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Kamakura, Japan, 247-8533
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Kodaira-shi, Japan, 187-8551
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Koriyama, Japan, 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.
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Kyoto-shi, Japan, 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.
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Mitaka-shi, Japan, 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.
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Shinjuku-Ku, Japan, 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.
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Shizuoka, Japan, 424-0911
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Takamatsu, Japan, 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.
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Tokyo, Japan, 113-0034
- 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.
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Tsu-shi, Japan, 514-8507
- 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.
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Białystok, Polen, 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.
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Bydgoszcz, Polen, 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.
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Lublin, Polen, 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.
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Poznan, Polen, 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.
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Sopot, Polen, 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.
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Warszawa, Polen, 01-697
- 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.
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Bayamón, Puerto Rico, 00961-6911
- Santa Cruz Behavioral PSC
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Las Piedras, Puerto Rico, 00771
- Cortex, PSC
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Rio Piedras, Puerto Rico, 00936
- University of Puerto Rico
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San Juan, Puerto Rico, 00918
- Instituto De Neurologia Dra. Ivonne Fraga
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San Juan, Puerto Rico, 00918
- SomniCare Sleep Institute
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San Juan, Puerto Rico, 00918
- Latin Clinical Trial Center
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Barcelona, Spanien, 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.
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Barcelona, Spanien, 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.
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Barcelona, Spanien, 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.
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Castellon de la Plana, Spanien, 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.
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Getafe, Spanien, 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.
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Getxo, Spanien, 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.
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Madrid, Spanien, 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.
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Plasencia, Spanien, 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.
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Salt, Spanien, 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.
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San Sebastian, Spanien, 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.
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Valencia, Spanien, 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.
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Valencia, Spanien, 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.
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Malmö, Sverige, 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.
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Mölndal, Sverige, 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.
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Stockholm, Sverige, 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.
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Umeå, Sverige, 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.
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Changhua, Taiwan, 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.
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Gwei Shan Township, Taiwan, 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.
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Jhonghe City, Taiwan, 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.
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Kaohsiung, Taiwan, 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.
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Kaohsiung, Taiwan, 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.
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Taichung, Taiwan, 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.
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Tainan, Taiwan, 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.
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Taipei, Taiwan, 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.
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Taipei, Taiwan, 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.
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Chemnitz, Tyskland, 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.
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
55 år til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Solanezumab
Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.
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Administreret IV
Andre navne:
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Eksperimentel: Placebo
Placebo given IV once every 4 weeks for up to 2 years.
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Administreret IV
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score
Tidsramme: Baseline, 24 Months
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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.
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Baseline, 24 Months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change From Baseline on Alzheimer´s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL)
Tidsramme: 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.
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Baseline, 24 Months
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Change From Baseline on the Mini Mental Status Examination (MMSE)
Tidsramme: Baseline, 24 Months
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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.
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Baseline, 24 Months
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Change From Baseline on the Montreal Cognitive Assessment (MoCA)
Tidsramme: Baseline, 24 Months
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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.
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Baseline, 24 Months
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Change From Baseline on the Functional Activities Questionnaire (FAQ)
Tidsramme: Baseline, 24 Months
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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.
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Baseline, 24 Months
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Change From Baseline on the Neuropsychiatric Inventory (NPI)
Tidsramme: Baseline, 24 Months
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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.
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Baseline, 24 Months
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Change From Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)
Tidsramme: Baseline, 24 Months
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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.
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Baseline, 24 Months
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Change From Baseline on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Tidsramme: Baseline, 24 Months
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RBANS is a brief neurocognitive battery with four alternate forms, measuring immediate and delayed memory, attention, language, and visuospatial/constructional skills.
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Baseline, 24 Months
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Change From Baseline on the Free and Cued Selective Reminding Test (FCSRT)
Tidsramme: Baseline, 24 Months
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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.
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Baseline, 24 Months
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Change From Baseline on the Resource Utilization in Dementia-Lite (RUD-Lite)
Tidsramme: Baseline, 24 Months
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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.
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Baseline, 24 Months
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Change From Baseline on the EuroQol 5-Dimensional Health-Related Quality of Life Scale (EQ-5D)
Tidsramme: Baseline, 24 Months
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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.
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Baseline, 24 Months
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Change From Baseline on the Quality of Life in Alzheimer's Disease Scale (QoL-AD)
Tidsramme: 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.
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Baseline, 24 Months
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Change From Baseline in Concentration of Plasma Amyloid-β Peptide (Aβ) and Plasma Solanezumab
Tidsramme: Baseline, 24 Months
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Concentration of amino acid peptide known as Aβ 1-42 in plasma.
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Baseline, 24 Months
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Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI)
Tidsramme: Baseline, 24 Months
|
MRI will be used to assess the effect of treatment on rate of whole brain volume.
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Baseline, 24 Months
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Change From Baseline in Florbetapir Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVr)
Tidsramme: 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.
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Baseline, 24 Months
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Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Aβ and CSF Tau Proteins
Tidsramme: 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.
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Baseline, 24 Months
|
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Change From Baseline in Neocortical Tau Deposits Using 18F-AV-1451 PET
Tidsramme: Baseline, 24 Months
|
Biomarker change will be analyzed to provide biomarker-based evidence that solanezumab affects the underlying disease pathology.
|
Baseline, 24 Months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2016
Primær færdiggørelse (Faktiske)
1. maj 2017
Studieafslutning (Faktiske)
1. maj 2017
Datoer for studieregistrering
Først indsendt
2. maj 2016
Først indsendt, der opfyldte QC-kriterier
2. maj 2016
Først opslået (Skøn)
3. maj 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. oktober 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. september 2019
Sidst verificeret
1. september 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 16349
- H8A-MC-LZBE (Anden identifikator: Eli Lilly and Company)
- 2016-000108-27 (EudraCT nummer)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
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-delingsadgangskriterier
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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