A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease (ExpeditionPRO)
25. September 2019 aktualisiert von: 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).
Studienübersicht
Status
Beendet
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
26
Phase
- Phase 3
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Chemnitz, Deutschland, 09131
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Kuopio, Finnland, 70210
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Oulu, Finnland, 90100
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Tampere, Finnland, 33100
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Turku, Finnland, 20014
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Vaasa, Finnland, 65130
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Amiens, Frankreich, 80054
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Bordeaux, Frankreich, 33076
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Bron, Frankreich, 69677
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Lille, Frankreich, 59037
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Marseille, Frankreich, 13385
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Montpellier, Frankreich, 34295
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Paris, Frankreich, 75015
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Paris, Frankreich, 75651
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Paris, Frankreich, 75010
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Rennes, Frankreich, 35033
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Strasbourg, Frankreich, 67000
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Toulouse, Frankreich, 31059
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Genova, Italien, 16132
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Milano, Italien, 20122
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Milano, Italien, 20133
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Monza, Italien, 20052
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Pavia, Italien, 27100
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Perugia, Italien, 06134
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Pisa, Italien, 56126
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Roma, Italien, 00161
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Roma, Italien, 00153
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Roma, Italien, 00179
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Roma, Italien, 00189
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Bunkyo-ku, Japan, 113-8655
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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
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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, 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
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Shizuoka, Japan, 424-0911
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Takamatsu, Japan, 760-8557
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Tokyo, Japan, 113-0034
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Tsu-shi, Japan, 514-8507
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Gatineau, Kanada, J8T 8J1
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Greenfield Park, Kanada, J4V 2J2
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Halifax, Kanada, B3S1M7
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Kentville, Kanada, B4N 4K9
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London, Kanada, N6C 0A7
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Ottawa, Kanada, KIN 5C8
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Peterborough, Kanada, K9H2P4
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Sherbrooke, Kanada, J1H1Z1
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Toronto, Kanada, M3B 2S7
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Białystok, Polen, 15-732
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Bydgoszcz, Polen, 85-796
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Lublin, Polen, 20-093
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Poznan, Polen, 30-856
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Sopot, Polen, 81-824
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Warszawa, Polen, 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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Malmö, Schweden, 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, Schweden, 43141
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Stockholm, Schweden, 113 61
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Umeå, Schweden, 90105
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Barcelona, Spanien, 08025
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Barcelona, Spanien, 08036
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Barcelona, Spanien, 08014
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Castellon de la Plana, Spanien, 12004
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Getafe, Spanien, 28905
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Getxo, Spanien, 48993
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Madrid, Spanien, 28006
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Plasencia, Spanien, 10600
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Salt, Spanien, 17190
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San Sebastian, Spanien, 20009
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Valencia, Spanien, 46017
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Valencia, Spanien, 46026
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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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Arizona
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Phoenix, Arizona, Vereinigte Staaten, 85006
- Banner Alzheimer's Institute
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Phoenix, Arizona, Vereinigte Staaten, 85013
- St Josephs Hospital and Medical Center
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Phoenix, Arizona, Vereinigte Staaten, 85004
- Xenoscience
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Sun City, Arizona, Vereinigte Staaten, 85351
- Banner Sun Health Research Institute
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Tucson, Arizona, Vereinigte Staaten, 85718
- Center For Neurosciences
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Tucson, Arizona, Vereinigte Staaten, 85724
- Arizona Health Sciences Center
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California
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Glendale, California, Vereinigte Staaten, 91206-4140
- Parexel Early Phase Unit at Glendale
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Oxnard, California, Vereinigte Staaten, 93030
- Pacific Neuroscience Medical Group
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Rancho Mirage, California, Vereinigte Staaten, 92270
- Desert Valley Research
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San Diego, California, Vereinigte Staaten, 92123
- Sharp Mesa Vista Hospital
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San Diego, California, Vereinigte Staaten, 92103
- Pacific Research Network Inc
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San Francisco, California, Vereinigte Staaten, 94114
- California Pacific Medical Center
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Santa Ana, California, Vereinigte Staaten, 92705
- Apex Research Institute
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Santa Clarita, California, Vereinigte Staaten, 91321
- Care Access Research LLC
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Sherman Oaks, California, Vereinigte Staaten, 91403
- California Neuroscience Research
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Valencia, California, Vereinigte Staaten, 91355
- Care Access Research
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Colorado
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Colorado Springs, Colorado, Vereinigte Staaten, 80910
- MCB Clinical Research Centers
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Denver, Colorado, Vereinigte Staaten, 80218
- Mile High Research Center
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Connecticut
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New Haven, Connecticut, Vereinigte Staaten, 06510
- Yale University School of Medicine
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Stamford, Connecticut, Vereinigte Staaten, 06905
- New England Institute for Clinical Research
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Delaware
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Newark, Delaware, Vereinigte Staaten, 19713
- Christiana Care Research Institute
-
-
Florida
-
Delray Beach, Florida, Vereinigte Staaten, 33445
- Brain Matters Research
-
Fort Myers, Florida, Vereinigte Staaten, 33912
- Neuropsychiatric Research Center of Southwest Florida
-
Hollywood, Florida, Vereinigte Staaten, 33021
- Sunrise Clinical Research
-
Jacksonville, Florida, Vereinigte Staaten, 32256
- Clinical NeuroScience Solutions Inc
-
Miami, Florida, Vereinigte Staaten, 33137
- Miami Jewish Health Systems
-
Miami Beach, Florida, Vereinigte Staaten, 33140
- Mount Sinai Medical Center
-
New Port Richey, Florida, Vereinigte Staaten, 34652
- Suncoast Clinical Research
-
Ocoee, Florida, Vereinigte Staaten, 34761
- Sensible Healthcare
-
Orlando, Florida, Vereinigte Staaten, 32806
- Compass Research
-
Pensacola, Florida, Vereinigte Staaten, 32502
- Pensacola Research Consultants, Inc.
-
Pompano Beach, Florida, Vereinigte Staaten, 33064
- Quantum Laboratories
-
Sarasota, Florida, Vereinigte Staaten, 34243
- Roskamp Institute
-
Tampa, Florida, Vereinigte Staaten, 33609
- Axiom Research
-
West Palm Beach, Florida, Vereinigte Staaten, 33407
- Premiere Research Institute at Palm Beach Neurology
-
-
Georgia
-
Atlanta, Georgia, Vereinigte Staaten, 30331
- Atlanta Center of Medical Research
-
Gainesville, Georgia, Vereinigte Staaten, 30501
- United Osteoporosis Center
-
-
Illinois
-
Champaign, Illinois, Vereinigte Staaten, 61820
- Christie Clinic, LLC
-
Elk Grove Village, Illinois, Vereinigte Staaten, 60007
- Alexian Brothers Medical Center
-
Winfield, Illinois, Vereinigte Staaten, 60190
- Central DuPage Hospital
-
-
Indiana
-
Fort Wayne, Indiana, Vereinigte Staaten, 46804
- Fort Wayne Neurological Center
-
Indianapolis, Indiana, Vereinigte Staaten, 46202
- Indiana University School of Medicine
-
Indianapolis, Indiana, Vereinigte Staaten, 46256
- Josephson Wallack Munshower Neurology
-
-
Kansas
-
Topeka, Kansas, Vereinigte Staaten, 66606
- Cotton O'Neil Clinic
-
Wichita, Kansas, Vereinigte Staaten, 67207
- Heartland Research Associates
-
-
Kentucky
-
Lexington, Kentucky, Vereinigte Staaten, 40503
- Baptist Health Medical Group
-
-
Louisiana
-
Lake Charles, Louisiana, Vereinigte Staaten, 70629
- Lake Charles Clinical Trials
-
-
Maine
-
Scarborough, Maine, Vereinigte Staaten, 04074
- Maine Neurology
-
-
Maryland
-
Baltimore, Maryland, Vereinigte Staaten, 21285
- Sheppard Pratt Health System
-
Baltimore, Maryland, Vereinigte Staaten, 21204
- Sheppard Pratt Health System
-
Baltimore, Maryland, Vereinigte Staaten, 21205
- Johns Hopkins University School of Medicine
-
Baltimore, Maryland, Vereinigte Staaten, 21208
- Pharmasite Research Inc
-
-
Massachusetts
-
Methuen, Massachusetts, Vereinigte Staaten, 01844
- ActivMed Practices & Research, Inc
-
Plymouth, Massachusetts, Vereinigte Staaten, 02360-4843
- Donald S Marks
-
-
Michigan
-
Farmington Hills, Michigan, Vereinigte Staaten, 48334
- Quest Research Institute
-
-
Mississippi
-
Hattiesburg, Mississippi, Vereinigte Staaten, 39401
- Hattiesburg Clinic
-
-
Missouri
-
Bolivar, Missouri, Vereinigte Staaten, 65613
- Clinvest
-
Chesterfield, Missouri, Vereinigte Staaten, 63141
- Clinical Research Professionals
-
Creve Coeur, Missouri, Vereinigte Staaten, 63141
- Millenium Psychiatric Associates LLC
-
Kansas City, Missouri, Vereinigte Staaten, 64111
- St Lukes Hospital
-
-
Nevada
-
Las Vegas, Nevada, Vereinigte Staaten, 89113
- Las Vegas Medical Research
-
-
New Hampshire
-
Nashua, New Hampshire, Vereinigte Staaten, 03060
- Healthy Perspectives Innovative Mental Health Services, PL
-
Portsmouth, New Hampshire, Vereinigte Staaten, 03801
- ActivMed Practices & Research, Inc
-
-
New Jersey
-
Eatontown, New Jersey, Vereinigte Staaten, 07724
- Memory Enhancement Center of America, Inc.
-
Monroe, New Jersey, Vereinigte Staaten, 08831
- Pyramid Clinical Research
-
Princeton, New Jersey, Vereinigte Staaten, 08540
- Princeton Medical Institute
-
Springfield, New Jersey, Vereinigte Staaten, 07081
- The Cognitive and Research Center of NJ
-
Toms River, New Jersey, Vereinigte Staaten, 08755
- Advanced Memory Research Institute of New Jersey
-
Toms River, New Jersey, Vereinigte Staaten, 08755
- Bio Behavioral Health
-
-
New York
-
Albany, New York, Vereinigte Staaten, 12206
- Albany Medical College
-
Staten Island, New York, Vereinigte Staaten, 10312
- Richmond Behavorial Associates
-
-
North Carolina
-
Charlotte, North Carolina, Vereinigte Staaten, 28270
- Alzheimer's Memory Center
-
Winston-Salem, North Carolina, Vereinigte Staaten, 27103
- Piedmont Medical Research
-
-
Ohio
-
Cincinnati, Ohio, Vereinigte Staaten, 45219
- University of Cincinnati Medical Center
-
Dayton, Ohio, Vereinigte Staaten, 45459
- Neurology Diagnostics, Inc.
-
Shaker Heights, Ohio, Vereinigte Staaten, 44122
- Insight Clinical Trials
-
-
Oregon
-
Portland, Oregon, Vereinigte Staaten, 97225
- Center for Cognitive Health
-
Portland, Oregon, Vereinigte Staaten, 97210
- Summit Research Network Inc
-
-
Pennsylvania
-
Abington, Pennsylvania, Vereinigte Staaten, 19090
- Abington Neurological Associates
-
Allentown, Pennsylvania, Vereinigte Staaten, 18104
- Lehigh Center for Clinical Research
-
Allentown, Pennsylvania, Vereinigte Staaten, 18103
- Lehigh Valley Hospital
-
Jenkintown, Pennsylvania, Vereinigte Staaten, 19046
- Clinical Trial Center, LLC, Psychiatry
-
Plains, Pennsylvania, Vereinigte Staaten, 18705
- Northeastern Pennsylvania Memory & Alzheimer's Center
-
-
Rhode Island
-
East Providence, Rhode Island, Vereinigte Staaten, 02914
- Rhode Island Mood & Memory Research Institute
-
Providence, Rhode Island, Vereinigte Staaten, 02906
- Butler Hospital
-
-
South Carolina
-
Indian Land, South Carolina, Vereinigte Staaten, 29707
- Metrolina Neurological Research Institute
-
-
Texas
-
Dallas, Texas, Vereinigte Staaten, 75231
- FutureSearch Trials
-
Dallas, Texas, Vereinigte Staaten, 75231
- Baylor AT&T Memory Center
-
Dallas, Texas, Vereinigte Staaten, 75219
- Baylor AT&T Memory Center
-
Houston, Texas, Vereinigte Staaten, 77030
- Houston Methodist
-
Houston, Texas, Vereinigte Staaten, 77054
- University of Texas Health Services Center - Houston
-
San Antonio, Texas, Vereinigte Staaten, 78229
- Clinical Trials of Texas, Inc.
-
San Antonio, Texas, Vereinigte Staaten, 78229
- Univ of Texas Health Science Center at San Antonio
-
-
Vermont
-
Bennington, Vermont, Vereinigte Staaten, 05201
- The Memory Clinic
-
-
Virginia
-
Norfolk, Virginia, Vereinigte Staaten, 23510
- Sentara Medical Group
-
Richmond, Virginia, Vereinigte Staaten, 23294
- National Clinical Research - Richmond
-
-
Washington
-
Kirkland, Washington, Vereinigte Staaten, 98034
- Evergreen Professional Plaza
-
-
Wisconsin
-
Middleton, Wisconsin, Vereinigte Staaten, 53562
- Dean Foundation for Health Research and Education
-
-
-
-
-
Bath, Vereinigtes Königreich, BA1 3NG
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Chelsea, Vereinigtes Königreich, W6 8RF
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Guildford, Vereinigtes Königreich, GU2 7YD
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
London, Vereinigtes Königreich, W1G 9RU
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Manchester, Vereinigtes Königreich, M13 9WL
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Scotland, Vereinigtes Königreich, 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.
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
55 Jahre bis 85 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Solanezumab
Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.
|
IV verabreicht
Andere Namen:
|
|
Experimental: Placebo
Placebo given IV once every 4 weeks for up to 2 years.
|
IV verabreicht
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change From Baseline on Alzheimer´s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL)
Zeitfenster: Baseline, 24 Months
|
The ADCS-MCI-ADL is a functional evaluation scale for MCI patients, based on information provided by an informant that describes the performance of participants in several ADLs.
Total score ranges from 0 to 69; lower score indicates greater disease severity.
|
Baseline, 24 Months
|
|
Change From Baseline on the Mini Mental Status Examination (MMSE)
Zeitfenster: Baseline, 24 Months
|
MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants.Total score ranges from 0 to 30; lower score indicates greater disease severity.
|
Baseline, 24 Months
|
|
Change From Baseline on the Montreal Cognitive Assessment (MoCA)
Zeitfenster: Baseline, 24 Months
|
The MoCA will be used as the global cognitive screening instrument.
It will also be administered in the clinical trial at baseline and the final visits of each phase as a secondary outcome measure of global cognition.
Scores on the MoCA range from 0-30 with 26-30 indicating normal global cognition.
|
Baseline, 24 Months
|
|
Change From Baseline on the Functional Activities Questionnaire (FAQ)
Zeitfenster: Baseline, 24 Months
|
FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant's ability to perform a variety of activities ranging from Writing checks, Assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, Traveling out of neighborhood, keeping track of current events and understanding media.
FAQ total score was calculated by adding the scores from each of the 10 items.
Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now = 1; Never did [the activity] but could do now = 0; Normal = 0; Has difficulty but does by self = 1; Requires assistance = 2; Dependent = 3).
The maximum FAQ total score is 30, with higher scores indicating greater impairment.
|
Baseline, 24 Months
|
|
Change From Baseline on the Neuropsychiatric Inventory (NPI)
Zeitfenster: Baseline, 24 Months
|
The NPI is a tool for assessing psychopathology in participants with dementia and other neurologic disorders.
Information is obtained from a caregiver familiar with the participant's behavior.
The score ranges from 12 to 144, with higher scores indicating greater disease severity.
|
Baseline, 24 Months
|
|
Change From Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)
Zeitfenster: Baseline, 24 Months
|
CDR-SB is a semi-structured interview of participants and their caregivers.
Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care.
Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.
|
Baseline, 24 Months
|
|
Change From Baseline on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Zeitfenster: Baseline, 24 Months
|
RBANS is a brief neurocognitive battery with four alternate forms, measuring immediate and delayed memory, attention, language, and visuospatial/constructional skills.
|
Baseline, 24 Months
|
|
Change From Baseline on the Free and Cued Selective Reminding Test (FCSRT)
Zeitfenster: Baseline, 24 Months
|
The FCSRT is a neuropsychological test of memory under conditions that control attention and cognitive processing in order to obtain an assessment of memory unconfounded by normal age-related changes in cognition.
|
Baseline, 24 Months
|
|
Change From Baseline on the Resource Utilization in Dementia-Lite (RUD-Lite)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Baseline, 24 Months
|
Biomarker change will be analyzed to provide biomarker-based evidence that solanezumab affects the underlying disease pathology.
|
Baseline, 24 Months
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Juni 2016
Primärer Abschluss (Tatsächlich)
1. Mai 2017
Studienabschluss (Tatsächlich)
1. Mai 2017
Studienanmeldedaten
Zuerst eingereicht
2. Mai 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
2. Mai 2016
Zuerst gepostet (Schätzen)
3. Mai 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
10. Oktober 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
25. September 2019
Zuletzt verifiziert
1. September 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 16349
- H8A-MC-LZBE (Andere Kennung: Eli Lilly and Company)
- 2016-000108-27 (EudraCT-Nummer)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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-Sharing-Zeitrahmen
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later.
Data will be indefinitely available for requesting.
IPD-Sharing-Zugriffskriterien
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- CSR
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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