A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease (ExpeditionPRO)
25. september 2019 oppdatert av: 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).
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
26
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
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
- 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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Halifax, Canada, 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.
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Kentville, Canada, 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.
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London, Canada, 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.
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Ottawa, Canada, 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.
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Peterborough, Canada, 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.
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Sherbrooke, Canada, 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.
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Toronto, Canada, 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.
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Kuopio, Finland, 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.
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Oulu, Finland, 90100
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Tampere, Finland, 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.
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Turku, Finland, 20014
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Vaasa, Finland, 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.
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Arizona
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Phoenix, Arizona, Forente stater, 85006
- Banner Alzheimer's Institute
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Phoenix, Arizona, Forente stater, 85013
- St Josephs Hospital and Medical Center
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Phoenix, Arizona, Forente stater, 85004
- Xenoscience
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Sun City, Arizona, Forente stater, 85351
- Banner Sun Health Research Institute
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Tucson, Arizona, Forente stater, 85718
- Center for Neurosciences
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Tucson, Arizona, Forente stater, 85724
- Arizona Health Sciences Center
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California
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Glendale, California, Forente stater, 91206-4140
- Parexel Early Phase Unit at Glendale
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Oxnard, California, Forente stater, 93030
- Pacific Neuroscience Medical Group
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Rancho Mirage, California, Forente stater, 92270
- Desert Valley Research
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San Diego, California, Forente stater, 92123
- Sharp Mesa Vista Hospital
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San Diego, California, Forente stater, 92103
- Pacific Research Network Inc
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San Francisco, California, Forente stater, 94114
- California Pacific Medical Center
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Santa Ana, California, Forente stater, 92705
- Apex Research Institute
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Santa Clarita, California, Forente stater, 91321
- Care Access Research LLC
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Sherman Oaks, California, Forente stater, 91403
- California Neuroscience Research
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Valencia, California, Forente stater, 91355
- Care Access Research
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Colorado
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Colorado Springs, Colorado, Forente stater, 80910
- MCB Clinical Research Centers
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Denver, Colorado, Forente stater, 80218
- Mile High Research Center
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Connecticut
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New Haven, Connecticut, Forente stater, 06510
- Yale University School of Medicine
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Stamford, Connecticut, Forente stater, 06905
- New England Institute for Clinical Research
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Delaware
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Newark, Delaware, Forente stater, 19713
- Christiana Care Research Institute
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Florida
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Delray Beach, Florida, Forente stater, 33445
- Brain Matters Research
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Fort Myers, Florida, Forente stater, 33912
- Neuropsychiatric Research Center of Southwest Florida
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Hollywood, Florida, Forente stater, 33021
- Sunrise Clinical Research
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Jacksonville, Florida, Forente stater, 32256
- Clinical NeuroScience Solutions Inc
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Miami, Florida, Forente stater, 33137
- Miami Jewish Health Systems
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Miami Beach, Florida, Forente stater, 33140
- Mount Sinai Medical Center
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New Port Richey, Florida, Forente stater, 34652
- Suncoast Clinical Research
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Ocoee, Florida, Forente stater, 34761
- Sensible Healthcare
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Orlando, Florida, Forente stater, 32806
- Compass Research
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Pensacola, Florida, Forente stater, 32502
- Pensacola Research Consultants, Inc.
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Pompano Beach, Florida, Forente stater, 33064
- Quantum Laboratories
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Sarasota, Florida, Forente stater, 34243
- Roskamp Institute
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Tampa, Florida, Forente stater, 33609
- Axiom Research
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West Palm Beach, Florida, Forente stater, 33407
- Premiere Research Institute at Palm Beach Neurology
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Georgia
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Atlanta, Georgia, Forente stater, 30331
- Atlanta Center of Medical Research
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Gainesville, Georgia, Forente stater, 30501
- United Osteoporosis Center
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Illinois
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Champaign, Illinois, Forente stater, 61820
- Christie Clinic, LLC
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Elk Grove Village, Illinois, Forente stater, 60007
- Alexian Brothers Medical Center
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Winfield, Illinois, Forente stater, 60190
- Central DuPage Hospital
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Indiana
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Fort Wayne, Indiana, Forente stater, 46804
- Fort Wayne Neurological Center
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Indianapolis, Indiana, Forente stater, 46202
- Indiana University School of Medicine
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Indianapolis, Indiana, Forente stater, 46256
- Josephson Wallack Munshower Neurology
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Kansas
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Topeka, Kansas, Forente stater, 66606
- Cotton O'Neil Clinic
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Wichita, Kansas, Forente stater, 67207
- Heartland Research Associates
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Kentucky
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Lexington, Kentucky, Forente stater, 40503
- Baptist Health Medical Group
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Louisiana
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Lake Charles, Louisiana, Forente stater, 70629
- Lake Charles Clinical Trials
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Maine
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Scarborough, Maine, Forente stater, 04074
- Maine Neurology
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Maryland
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Baltimore, Maryland, Forente stater, 21285
- Sheppard Pratt Health System
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Baltimore, Maryland, Forente stater, 21204
- Sheppard Pratt Health System
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Baltimore, Maryland, Forente stater, 21205
- Johns Hopkins University School of Medicine
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Baltimore, Maryland, Forente stater, 21208
- Pharmasite Research Inc
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Massachusetts
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Methuen, Massachusetts, Forente stater, 01844
- ActivMed Practices & Research, Inc
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Plymouth, Massachusetts, Forente stater, 02360-4843
- Donald S Marks
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Michigan
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Farmington Hills, Michigan, Forente stater, 48334
- Quest Research Institute
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Mississippi
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Hattiesburg, Mississippi, Forente stater, 39401
- Hattiesburg Clinic
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Missouri
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Bolivar, Missouri, Forente stater, 65613
- Clinvest
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Chesterfield, Missouri, Forente stater, 63141
- Clinical Research Professionals
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Creve Coeur, Missouri, Forente stater, 63141
- Millenium Psychiatric Associates LLC
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Kansas City, Missouri, Forente stater, 64111
- St Lukes Hospital
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Nevada
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Las Vegas, Nevada, Forente stater, 89113
- Las Vegas Medical Research
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New Hampshire
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Nashua, New Hampshire, Forente stater, 03060
- Healthy Perspectives Innovative Mental Health Services, PL
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Portsmouth, New Hampshire, Forente stater, 03801
- ActivMed Practices & Research, Inc
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New Jersey
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Eatontown, New Jersey, Forente stater, 07724
- Memory Enhancement Center of America, Inc.
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Monroe, New Jersey, Forente stater, 08831
- Pyramid Clinical Research
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Princeton, New Jersey, Forente stater, 08540
- Princeton Medical Institute
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Springfield, New Jersey, Forente stater, 07081
- The Cognitive and Research Center of NJ
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Toms River, New Jersey, Forente stater, 08755
- Advanced Memory Research Institute of New Jersey
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Toms River, New Jersey, Forente stater, 08755
- Bio Behavioral Health
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New York
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Albany, New York, Forente stater, 12206
- Albany Medical College
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Staten Island, New York, Forente stater, 10312
- Richmond Behavorial Associates
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North Carolina
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Charlotte, North Carolina, Forente stater, 28270
- Alzheimer's Memory Center
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Winston-Salem, North Carolina, Forente stater, 27103
- Piedmont Medical Research
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Ohio
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Cincinnati, Ohio, Forente stater, 45219
- University of Cincinnati Medical Center
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Dayton, Ohio, Forente stater, 45459
- Neurology Diagnostics, Inc.
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Shaker Heights, Ohio, Forente stater, 44122
- Insight Clinical Trials
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Oregon
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Portland, Oregon, Forente stater, 97225
- Center for Cognitive Health
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Portland, Oregon, Forente stater, 97210
- Summit Research Network Inc
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Pennsylvania
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Abington, Pennsylvania, Forente stater, 19090
- Abington Neurological Associates
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Allentown, Pennsylvania, Forente stater, 18104
- Lehigh Center for Clinical Research
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Allentown, Pennsylvania, Forente stater, 18103
- LeHigh Valley Hospital
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Jenkintown, Pennsylvania, Forente stater, 19046
- Clinical Trial Center, LLC, Psychiatry
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Plains, Pennsylvania, Forente stater, 18705
- Northeastern Pennsylvania Memory & Alzheimer's Center
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Rhode Island
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East Providence, Rhode Island, Forente stater, 02914
- Rhode Island Mood & Memory Research Institute
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Providence, Rhode Island, Forente stater, 02906
- Butler Hospital
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South Carolina
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Indian Land, South Carolina, Forente stater, 29707
- Metrolina Neurological Research Institute
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Texas
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Dallas, Texas, Forente stater, 75231
- FutureSearch Trials
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Dallas, Texas, Forente stater, 75231
- Baylor AT&T Memory Center
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Dallas, Texas, Forente stater, 75219
- Baylor AT&T Memory Center
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Houston, Texas, Forente stater, 77030
- Houston Methodist
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Houston, Texas, Forente stater, 77054
- University of Texas Health Services Center - Houston
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San Antonio, Texas, Forente stater, 78229
- Clinical Trials of Texas, Inc.
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San Antonio, Texas, Forente stater, 78229
- Univ of Texas Health Science Center at San Antonio
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Vermont
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Bennington, Vermont, Forente stater, 05201
- The Memory Clinic
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Virginia
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Norfolk, Virginia, Forente stater, 23510
- Sentara Medical Group
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Richmond, Virginia, Forente stater, 23294
- National Clinical Research - Richmond
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Washington
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Kirkland, Washington, Forente stater, 98034
- Evergreen Professional Plaza
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Wisconsin
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Middleton, Wisconsin, Forente stater, 53562
- Dean Foundation for Health Research and Education
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Amiens, Frankrike, 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, Frankrike, 33076
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Bron, Frankrike, 69677
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Lille, Frankrike, 59037
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Marseille, Frankrike, 13385
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Montpellier, Frankrike, 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, Frankrike, 75015
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Paris, Frankrike, 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, Frankrike, 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, Frankrike, 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.
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Strasbourg, Frankrike, 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.
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Toulouse, Frankrike, 31059
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Genova, Italia, 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, Italia, 20122
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Milano, Italia, 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.
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Monza, Italia, 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, Italia, 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, Italia, 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, Italia, 56126
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Roma, Italia, 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, Italia, 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, Italia, 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, Italia, 00189
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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
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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, Spania, 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, Spania, 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, Spania, 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, Spania, 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, Spania, 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, Spania, 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, Spania, 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, Spania, 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, Spania, 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, Spania, 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, Spania, 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, Spania, 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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Bath, Storbritannia, 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.
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Chelsea, Storbritannia, 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.
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Guildford, Storbritannia, 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.
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London, Storbritannia, 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.
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Manchester, Storbritannia, 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.
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Scotland, Storbritannia, 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.
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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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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
55 år til 85 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Solanezumab
Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.
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Administrert IV
Andre navn:
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Eksperimentell: Placebo
Placebo given IV once every 4 weeks for up to 2 years.
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Administrert IV
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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.
|
Baseline, 24 Months
|
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Change From Baseline on the Mini Mental Status Examination (MMSE)
Tidsramme: 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.
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Baseline, 24 Months
|
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Change From Baseline on the Montreal Cognitive Assessment (MoCA)
Tidsramme: 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
|
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Change From Baseline on the Functional Activities Questionnaire (FAQ)
Tidsramme: 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
|
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Change From Baseline on the Neuropsychiatric Inventory (NPI)
Tidsramme: 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
|
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Change From Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)
Tidsramme: 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
|
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Change From Baseline on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Tidsramme: 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
|
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Change From Baseline on the Free and Cued Selective Reminding Test (FCSRT)
Tidsramme: 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.
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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
|
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)
Tidsramme: 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)
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.
|
Baseline, 24 Months
|
|
Change From Baseline in Concentration of Plasma Amyloid-β Peptide (Aβ) and Plasma Solanezumab
Tidsramme: 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)
Tidsramme: 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)
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.
|
Baseline, 24 Months
|
|
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.
|
Baseline, 24 Months
|
|
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juni 2016
Primær fullføring (Faktiske)
1. mai 2017
Studiet fullført (Faktiske)
1. mai 2017
Datoer for studieregistrering
Først innsendt
2. mai 2016
Først innsendt som oppfylte QC-kriteriene
2. mai 2016
Først lagt ut (Anslag)
3. mai 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. oktober 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. september 2019
Sist bekreftet
1. september 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 16349
- H8A-MC-LZBE (Annen identifikator: Eli Lilly and Company)
- 2016-000108-27 (EudraCT-nummer)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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.
Tilgangskriterier for IPD-deling
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- CSR
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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