A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease (ExpeditionPRO)
25 de septiembre de 2019 actualizado por: 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).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
26
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Chemnitz, Alemania, 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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Gatineau, Canadá, 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, Canadá, J4V 2J2
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Halifax, Canadá, 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, Canadá, B4N 4K9
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London, Canadá, N6C 0A7
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Ottawa, Canadá, KIN 5C8
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Peterborough, Canadá, 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, Canadá, 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, Canadá, M3B 2S7
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Barcelona, España, 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, España, 08036
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Barcelona, España, 08014
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Castellon de la Plana, España, 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, España, 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, España, 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, España, 28006
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Plasencia, España, 10600
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Salt, España, 17190
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San Sebastian, España, 20009
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Valencia, España, 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, España, 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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Arizona
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Phoenix, Arizona, Estados Unidos, 85006
- Banner Alzheimer's Institute
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Phoenix, Arizona, Estados Unidos, 85013
- St Josephs Hospital and Medical Center
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Phoenix, Arizona, Estados Unidos, 85004
- Xenoscience
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Sun City, Arizona, Estados Unidos, 85351
- Banner Sun Health Research Institute
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Tucson, Arizona, Estados Unidos, 85718
- Center For Neurosciences
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Tucson, Arizona, Estados Unidos, 85724
- Arizona Health Sciences Center
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California
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Glendale, California, Estados Unidos, 91206-4140
- Parexel Early Phase Unit at Glendale
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Oxnard, California, Estados Unidos, 93030
- Pacific Neuroscience Medical Group
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Rancho Mirage, California, Estados Unidos, 92270
- Desert Valley Research
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San Diego, California, Estados Unidos, 92123
- Sharp Mesa Vista Hospital
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San Diego, California, Estados Unidos, 92103
- Pacific Research Network Inc
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San Francisco, California, Estados Unidos, 94114
- California Pacific Medical Center
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Santa Ana, California, Estados Unidos, 92705
- Apex Research Institute
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Santa Clarita, California, Estados Unidos, 91321
- Care Access Research LLC
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Sherman Oaks, California, Estados Unidos, 91403
- California Neuroscience Research
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Valencia, California, Estados Unidos, 91355
- Care Access Research
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Colorado
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Colorado Springs, Colorado, Estados Unidos, 80910
- MCB Clinical Research Centers
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Denver, Colorado, Estados Unidos, 80218
- Mile High Research Center
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06510
- Yale University School of Medicine
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Stamford, Connecticut, Estados Unidos, 06905
- New England Institute for Clinical Research
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Delaware
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Newark, Delaware, Estados Unidos, 19713
- Christiana Care Research Institute
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Florida
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Delray Beach, Florida, Estados Unidos, 33445
- Brain Matters Research
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Fort Myers, Florida, Estados Unidos, 33912
- Neuropsychiatric Research Center of Southwest Florida
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Hollywood, Florida, Estados Unidos, 33021
- Sunrise Clinical Research
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Jacksonville, Florida, Estados Unidos, 32256
- Clinical Neuroscience Solutions Inc
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Miami, Florida, Estados Unidos, 33137
- Miami Jewish Health Systems
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Miami Beach, Florida, Estados Unidos, 33140
- Mount Sinai Medical Center
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New Port Richey, Florida, Estados Unidos, 34652
- Suncoast Clinical Research
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Ocoee, Florida, Estados Unidos, 34761
- Sensible Healthcare
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Orlando, Florida, Estados Unidos, 32806
- Compass Research
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Pensacola, Florida, Estados Unidos, 32502
- Pensacola Research Consultants, Inc.
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Pompano Beach, Florida, Estados Unidos, 33064
- Quantum Laboratories
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Sarasota, Florida, Estados Unidos, 34243
- Roskamp Institute
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Tampa, Florida, Estados Unidos, 33609
- Axiom Research
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West Palm Beach, Florida, Estados Unidos, 33407
- Premiere Research Institute at Palm Beach Neurology
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Georgia
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Atlanta, Georgia, Estados Unidos, 30331
- Atlanta Center of Medical Research
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Gainesville, Georgia, Estados Unidos, 30501
- United Osteoporosis Center
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Illinois
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Champaign, Illinois, Estados Unidos, 61820
- Christie Clinic, LLC
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Elk Grove Village, Illinois, Estados Unidos, 60007
- Alexian Brothers Medical Center
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Winfield, Illinois, Estados Unidos, 60190
- Central DuPage Hospital
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Indiana
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Fort Wayne, Indiana, Estados Unidos, 46804
- Fort Wayne Neurological Center
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Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University School of Medicine
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Indianapolis, Indiana, Estados Unidos, 46256
- Josephson Wallack Munshower Neurology
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Kansas
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Topeka, Kansas, Estados Unidos, 66606
- Cotton O'Neil Clinic
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Wichita, Kansas, Estados Unidos, 67207
- Heartland Research Associates
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40503
- Baptist Health Medical Group
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Louisiana
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Lake Charles, Louisiana, Estados Unidos, 70629
- Lake Charles Clinical Trials
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Maine
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Scarborough, Maine, Estados Unidos, 04074
- Maine Neurology
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Maryland
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Baltimore, Maryland, Estados Unidos, 21285
- Sheppard Pratt Health System
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Baltimore, Maryland, Estados Unidos, 21204
- Sheppard Pratt Health System
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Baltimore, Maryland, Estados Unidos, 21205
- Johns Hopkins University School of Medicine
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Baltimore, Maryland, Estados Unidos, 21208
- Pharmasite Research Inc
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Massachusetts
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Methuen, Massachusetts, Estados Unidos, 01844
- ActivMed Practices & Research, Inc
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Plymouth, Massachusetts, Estados Unidos, 02360-4843
- Donald S Marks
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Michigan
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Farmington Hills, Michigan, Estados Unidos, 48334
- Quest Research Institute
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Mississippi
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Hattiesburg, Mississippi, Estados Unidos, 39401
- Hattiesburg Clinic
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Missouri
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Bolivar, Missouri, Estados Unidos, 65613
- Clinvest
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Chesterfield, Missouri, Estados Unidos, 63141
- Clinical Research Professionals
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Creve Coeur, Missouri, Estados Unidos, 63141
- Millenium Psychiatric Associates LLC
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Kansas City, Missouri, Estados Unidos, 64111
- St Lukes Hospital
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89113
- Las Vegas Medical Research
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New Hampshire
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Nashua, New Hampshire, Estados Unidos, 03060
- Healthy Perspectives Innovative Mental Health Services, PL
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Portsmouth, New Hampshire, Estados Unidos, 03801
- ActivMed Practices & Research, Inc
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New Jersey
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Eatontown, New Jersey, Estados Unidos, 07724
- Memory Enhancement Center of America, Inc.
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Monroe, New Jersey, Estados Unidos, 08831
- Pyramid Clinical Research
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Princeton, New Jersey, Estados Unidos, 08540
- Princeton Medical Institute
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Springfield, New Jersey, Estados Unidos, 07081
- The Cognitive and Research Center of NJ
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Toms River, New Jersey, Estados Unidos, 08755
- Advanced Memory Research Institute of New Jersey
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Toms River, New Jersey, Estados Unidos, 08755
- Bio Behavioral Health
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New York
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Albany, New York, Estados Unidos, 12206
- Albany Medical College
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Staten Island, New York, Estados Unidos, 10312
- Richmond Behavorial Associates
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28270
- Alzheimer's Memory Center
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Winston-Salem, North Carolina, Estados Unidos, 27103
- Piedmont Medical Research
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45219
- University of Cincinnati Medical Center
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Dayton, Ohio, Estados Unidos, 45459
- Neurology Diagnostics, Inc.
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Shaker Heights, Ohio, Estados Unidos, 44122
- Insight Clinical Trials
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Oregon
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Portland, Oregon, Estados Unidos, 97225
- Center for Cognitive Health
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Portland, Oregon, Estados Unidos, 97210
- Summit Research Network Inc
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Pennsylvania
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Abington, Pennsylvania, Estados Unidos, 19090
- Abington Neurological Associates
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Allentown, Pennsylvania, Estados Unidos, 18104
- Lehigh Center For Clinical Research
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Allentown, Pennsylvania, Estados Unidos, 18103
- Lehigh Valley Hospital
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Jenkintown, Pennsylvania, Estados Unidos, 19046
- Clinical Trial Center, LLC, Psychiatry
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Plains, Pennsylvania, Estados Unidos, 18705
- Northeastern Pennsylvania Memory & Alzheimer's Center
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Rhode Island
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East Providence, Rhode Island, Estados Unidos, 02914
- Rhode Island Mood & Memory Research Institute
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Providence, Rhode Island, Estados Unidos, 02906
- Butler Hospital
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South Carolina
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Indian Land, South Carolina, Estados Unidos, 29707
- Metrolina Neurological Research Institute
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Texas
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Dallas, Texas, Estados Unidos, 75231
- FutureSearch Trials
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Dallas, Texas, Estados Unidos, 75231
- Baylor AT&T Memory Center
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Dallas, Texas, Estados Unidos, 75219
- Baylor AT&T Memory Center
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Houston, Texas, Estados Unidos, 77030
- Houston Methodist
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Houston, Texas, Estados Unidos, 77054
- University of Texas Health Services Center - Houston
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San Antonio, Texas, Estados Unidos, 78229
- Clinical Trials of Texas, Inc.
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San Antonio, Texas, Estados Unidos, 78229
- Univ of Texas Health Science Center at San Antonio
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Vermont
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Bennington, Vermont, Estados Unidos, 05201
- The Memory Clinic
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Virginia
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Norfolk, Virginia, Estados Unidos, 23510
- Sentara Medical Group
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Richmond, Virginia, Estados Unidos, 23294
- National Clinical Research - Richmond
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Washington
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Kirkland, Washington, Estados Unidos, 98034
- Evergreen Professional Plaza
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Wisconsin
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Middleton, Wisconsin, Estados Unidos, 53562
- Dean Foundation for Health Research and Education
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Kuopio, Finlandia, 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, Finlandia, 90100
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tampere, Finlandia, 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, Finlandia, 20014
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Vaasa, Finlandia, 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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Amiens, Francia, 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, Francia, 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, Francia, 69677
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Lille, Francia, 59037
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Marseille, Francia, 13385
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Montpellier, Francia, 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, Francia, 75015
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Paris, Francia, 75651
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Paris, Francia, 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, Francia, 35033
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Strasbourg, Francia, 67000
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Toulouse, Francia, 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
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, 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
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Perugia, Italia, 06134
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Pisa, Italia, 56126
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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
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Roma, Italia, 00179
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Roma, Italia, 00189
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Bunkyo-ku, Japón, 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, Japón, 113-8431
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hachioji, Japón, 193-0998
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hyogo, Japón, 673-0848
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kamakura, Japón, 247-8533
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kodaira-shi, Japón, 187-8551
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Koriyama, Japón, 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, Japón, 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, Japón, 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, Japón, 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, Japón, 424-0911
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Takamatsu, Japón, 760-8557
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Tokyo, Japón, 113-0034
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Tsu-shi, Japón, 514-8507
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Białystok, Polonia, 15-732
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Bydgoszcz, Polonia, 85-796
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Lublin, Polonia, 20-093
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Poznan, Polonia, 30-856
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Sopot, Polonia, 81-824
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Warszawa, Polonia, 01-697
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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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Bath, Reino Unido, 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, Reino Unido, W6 8RF
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Guildford, Reino Unido, GU2 7YD
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London, Reino Unido, W1G 9RU
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Manchester, Reino Unido, M13 9WL
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Scotland, Reino Unido, G20 0XA
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Malmö, Suecia, 20502
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Mölndal, Suecia, 43141
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Stockholm, Suecia, 113 61
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Umeå, Suecia, 90105
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Changhua, Taiwán, 500
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Gwei Shan Township, Taiwán, 333
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Jhonghe City, Taiwán, 235
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Kaohsiung, Taiwán, 80756
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Kaohsiung, Taiwán, 83301
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Taichung, Taiwán, 40447
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Tainan, Taiwán, 70403
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Taipei, Taiwán, 10048
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Taipei, Taiwán, 11217
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
55 años a 85 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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.)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Solanezumab
Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.
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IV administrado
Otros nombres:
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Experimental: Placebo
Placebo given IV once every 4 weeks for up to 2 years.
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IV administrado
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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)
Periodo de tiempo: Baseline, 24 Months
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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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: Baseline, 24 Months
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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
Periodo de tiempo: 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)
Periodo de tiempo: Baseline, 24 Months
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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)
Periodo de tiempo: Baseline, 24 Months
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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
Periodo de tiempo: Baseline, 24 Months
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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
Periodo de tiempo: Baseline, 24 Months
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Biomarker change will be analyzed to provide biomarker-based evidence that solanezumab affects the underlying disease pathology.
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Baseline, 24 Months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de junio de 2016
Finalización primaria (Actual)
1 de mayo de 2017
Finalización del estudio (Actual)
1 de mayo de 2017
Fechas de registro del estudio
Enviado por primera vez
2 de mayo de 2016
Primero enviado que cumplió con los criterios de control de calidad
2 de mayo de 2016
Publicado por primera vez (Estimar)
3 de mayo de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de octubre de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
25 de septiembre de 2019
Última verificación
1 de septiembre de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 16349
- H8A-MC-LZBE (Otro identificador: Eli Lilly and Company)
- 2016-000108-27 (Número EudraCT)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
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.
Marco de tiempo para compartir IPD
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.
Criterios de acceso compartido de IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- RSC
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .