A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease (ExpeditionPRO)
25 września 2019 zaktualizowane przez: 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).
Przegląd badań
Status
Status
Zakończony
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Typ studiów
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
Zapisy
26
Faza
Faza
- Faza 3
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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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
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Tampere, Finlandia, 33100
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Turku, Finlandia, 20014
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Vaasa, Finlandia, 65130
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Amiens, Francja, 80054
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Bordeaux, Francja, 33076
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Bron, Francja, 69677
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Lille, Francja, 59037
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Marseille, Francja, 13385
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Montpellier, Francja, 34295
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Paris, Francja, 75015
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Paris, Francja, 75651
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Paris, Francja, 75010
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Rennes, Francja, 35033
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Strasbourg, Francja, 67000
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Toulouse, Francja, 31059
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Barcelona, Hiszpania, 08025
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Barcelona, Hiszpania, 08036
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Barcelona, Hiszpania, 08014
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Castellon de la Plana, Hiszpania, 12004
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Getafe, Hiszpania, 28905
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Getxo, Hiszpania, 48993
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Madrid, Hiszpania, 28006
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Plasencia, Hiszpania, 10600
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Salt, Hiszpania, 17190
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San Sebastian, Hiszpania, 20009
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Valencia, Hiszpania, 46017
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Valencia, Hiszpania, 46026
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Bunkyo-ku, Japonia, 113-8655
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Bunkyo-ku, Japonia, 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, Japonia, 193-0998
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Hyogo, Japonia, 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, Japonia, 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, Japonia, 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, Japonia, 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, Japonia, 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, Japonia, 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, Japonia, 160-8582
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Shizuoka, Japonia, 424-0911
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Takamatsu, Japonia, 760-8557
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Tokyo, Japonia, 113-0034
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Tsu-shi, Japonia, 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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Gatineau, Kanada, J8T 8J1
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Greenfield Park, Kanada, 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, Kanada, 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, Kanada, 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, Kanada, 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, Kanada, 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, Kanada, 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, Kanada, J1H1Z1
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Toronto, Kanada, M3B 2S7
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Chemnitz, Niemcy, 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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Białystok, Polska, 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, Polska, 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, Polska, 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, Polska, 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, Polska, 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, Polska, 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, Portoryko, 00961-6911
- Santa Cruz Behavioral PSC
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Las Piedras, Portoryko, 00771
- Cortex, PSC
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Rio Piedras, Portoryko, 00936
- University of Puerto Rico
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San Juan, Portoryko, 00918
- Instituto De Neurologia Dra. Ivonne Fraga
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San Juan, Portoryko, 00918
- SomniCare Sleep Institute
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San Juan, Portoryko, 00918
- Latin Clinical Trial Center
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Arizona
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Phoenix, Arizona, Stany Zjednoczone, 85006
- Banner Alzheimer's Institute
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Phoenix, Arizona, Stany Zjednoczone, 85013
- St Josephs Hospital and Medical Center
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Phoenix, Arizona, Stany Zjednoczone, 85004
- Xenoscience
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Sun City, Arizona, Stany Zjednoczone, 85351
- Banner Sun Health Research Institute
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Tucson, Arizona, Stany Zjednoczone, 85718
- Center For Neurosciences
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Tucson, Arizona, Stany Zjednoczone, 85724
- Arizona Health Sciences Center
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California
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Glendale, California, Stany Zjednoczone, 91206-4140
- Parexel Early Phase Unit at Glendale
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Oxnard, California, Stany Zjednoczone, 93030
- Pacific Neuroscience Medical Group
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Rancho Mirage, California, Stany Zjednoczone, 92270
- Desert Valley Research
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San Diego, California, Stany Zjednoczone, 92123
- Sharp Mesa Vista Hospital
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San Diego, California, Stany Zjednoczone, 92103
- Pacific Research Network Inc
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San Francisco, California, Stany Zjednoczone, 94114
- California Pacific Medical Center
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Santa Ana, California, Stany Zjednoczone, 92705
- Apex Research Institute
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Santa Clarita, California, Stany Zjednoczone, 91321
- Care Access Research LLC
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Sherman Oaks, California, Stany Zjednoczone, 91403
- California Neuroscience Research
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Valencia, California, Stany Zjednoczone, 91355
- Care Access Research
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Colorado
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Colorado Springs, Colorado, Stany Zjednoczone, 80910
- MCB Clinical Research Centers
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Denver, Colorado, Stany Zjednoczone, 80218
- Mile High Research Center
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Connecticut
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New Haven, Connecticut, Stany Zjednoczone, 06510
- Yale University School Of Medicine
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Stamford, Connecticut, Stany Zjednoczone, 06905
- New England Institute for Clinical Research
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Delaware
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Newark, Delaware, Stany Zjednoczone, 19713
- Christiana Care Research Institute
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Florida
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Delray Beach, Florida, Stany Zjednoczone, 33445
- Brain Matters Research
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Fort Myers, Florida, Stany Zjednoczone, 33912
- Neuropsychiatric Research Center of Southwest Florida
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Hollywood, Florida, Stany Zjednoczone, 33021
- Sunrise Clinical Research
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Jacksonville, Florida, Stany Zjednoczone, 32256
- Clinical Neuroscience Solutions Inc
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Miami, Florida, Stany Zjednoczone, 33137
- Miami Jewish Health Systems
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Miami Beach, Florida, Stany Zjednoczone, 33140
- Mount Sinai Medical Center
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New Port Richey, Florida, Stany Zjednoczone, 34652
- Suncoast Clinical Research
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Ocoee, Florida, Stany Zjednoczone, 34761
- Sensible Healthcare
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Orlando, Florida, Stany Zjednoczone, 32806
- Compass Research
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Pensacola, Florida, Stany Zjednoczone, 32502
- Pensacola Research Consultants, Inc.
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Pompano Beach, Florida, Stany Zjednoczone, 33064
- Quantum Laboratories
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Sarasota, Florida, Stany Zjednoczone, 34243
- Roskamp Institute
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Tampa, Florida, Stany Zjednoczone, 33609
- Axiom Research
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West Palm Beach, Florida, Stany Zjednoczone, 33407
- Premiere Research Institute at Palm Beach Neurology
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Georgia
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Atlanta, Georgia, Stany Zjednoczone, 30331
- Atlanta Center of Medical Research
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Gainesville, Georgia, Stany Zjednoczone, 30501
- United Osteoporosis Center
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Illinois
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Champaign, Illinois, Stany Zjednoczone, 61820
- Christie Clinic, LLC
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Elk Grove Village, Illinois, Stany Zjednoczone, 60007
- Alexian Brothers Medical Center
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Winfield, Illinois, Stany Zjednoczone, 60190
- Central DuPage Hospital
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Indiana
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Fort Wayne, Indiana, Stany Zjednoczone, 46804
- Fort Wayne Neurological Center
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Indianapolis, Indiana, Stany Zjednoczone, 46202
- Indiana University School of Medicine
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Indianapolis, Indiana, Stany Zjednoczone, 46256
- Josephson Wallack Munshower Neurology
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Kansas
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Topeka, Kansas, Stany Zjednoczone, 66606
- Cotton O'Neil Clinic
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Wichita, Kansas, Stany Zjednoczone, 67207
- Heartland Research Associates
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Kentucky
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Lexington, Kentucky, Stany Zjednoczone, 40503
- Baptist Health Medical Group
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Louisiana
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Lake Charles, Louisiana, Stany Zjednoczone, 70629
- Lake Charles Clinical Trials
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Maine
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Scarborough, Maine, Stany Zjednoczone, 04074
- Maine Neurology
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Maryland
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Baltimore, Maryland, Stany Zjednoczone, 21285
- Sheppard Pratt Health System
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Baltimore, Maryland, Stany Zjednoczone, 21204
- Sheppard Pratt Health System
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Baltimore, Maryland, Stany Zjednoczone, 21205
- Johns Hopkins University School Of Medicine
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Baltimore, Maryland, Stany Zjednoczone, 21208
- Pharmasite Research Inc
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Massachusetts
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Methuen, Massachusetts, Stany Zjednoczone, 01844
- ActivMed Practices & Research, Inc
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Plymouth, Massachusetts, Stany Zjednoczone, 02360-4843
- Donald S Marks
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Michigan
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Farmington Hills, Michigan, Stany Zjednoczone, 48334
- Quest Research Institute
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Mississippi
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Hattiesburg, Mississippi, Stany Zjednoczone, 39401
- Hattiesburg Clinic
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Missouri
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Bolivar, Missouri, Stany Zjednoczone, 65613
- Clinvest
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Chesterfield, Missouri, Stany Zjednoczone, 63141
- Clinical Research Professionals
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Creve Coeur, Missouri, Stany Zjednoczone, 63141
- Millenium Psychiatric Associates LLC
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Kansas City, Missouri, Stany Zjednoczone, 64111
- St Lukes Hospital
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Nevada
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Las Vegas, Nevada, Stany Zjednoczone, 89113
- Las Vegas Medical Research
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New Hampshire
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Nashua, New Hampshire, Stany Zjednoczone, 03060
- Healthy Perspectives Innovative Mental Health Services, PL
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Portsmouth, New Hampshire, Stany Zjednoczone, 03801
- ActivMed Practices & Research, Inc
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New Jersey
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Eatontown, New Jersey, Stany Zjednoczone, 07724
- Memory Enhancement Center of America, Inc.
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Monroe, New Jersey, Stany Zjednoczone, 08831
- Pyramid Clinical Research
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Princeton, New Jersey, Stany Zjednoczone, 08540
- Princeton Medical Institute
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Springfield, New Jersey, Stany Zjednoczone, 07081
- The Cognitive and Research Center of NJ
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Toms River, New Jersey, Stany Zjednoczone, 08755
- Advanced Memory Research Institute of New Jersey
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Toms River, New Jersey, Stany Zjednoczone, 08755
- Bio Behavioral Health
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New York
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Albany, New York, Stany Zjednoczone, 12206
- Albany Medical College
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Staten Island, New York, Stany Zjednoczone, 10312
- Richmond Behavorial Associates
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North Carolina
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Charlotte, North Carolina, Stany Zjednoczone, 28270
- Alzheimer's Memory Center
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Winston-Salem, North Carolina, Stany Zjednoczone, 27103
- Piedmont Medical Research
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Ohio
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Cincinnati, Ohio, Stany Zjednoczone, 45219
- University of Cincinnati Medical Center
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Dayton, Ohio, Stany Zjednoczone, 45459
- Neurology Diagnostics, Inc.
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Shaker Heights, Ohio, Stany Zjednoczone, 44122
- Insight Clinical Trials
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Oregon
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Portland, Oregon, Stany Zjednoczone, 97225
- Center for Cognitive Health
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Portland, Oregon, Stany Zjednoczone, 97210
- Summit Research Network Inc
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Pennsylvania
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Abington, Pennsylvania, Stany Zjednoczone, 19090
- Abington Neurological Associates
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Allentown, Pennsylvania, Stany Zjednoczone, 18104
- Lehigh Center For Clinical Research
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Allentown, Pennsylvania, Stany Zjednoczone, 18103
- LeHigh Valley Hospital
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Jenkintown, Pennsylvania, Stany Zjednoczone, 19046
- Clinical Trial Center, LLC, Psychiatry
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Plains, Pennsylvania, Stany Zjednoczone, 18705
- Northeastern Pennsylvania Memory & Alzheimer's Center
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Rhode Island
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East Providence, Rhode Island, Stany Zjednoczone, 02914
- Rhode Island Mood & Memory Research Institute
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Providence, Rhode Island, Stany Zjednoczone, 02906
- Butler Hospital
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South Carolina
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Indian Land, South Carolina, Stany Zjednoczone, 29707
- Metrolina Neurological Research Institute
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Texas
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Dallas, Texas, Stany Zjednoczone, 75231
- FutureSearch Trials
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Dallas, Texas, Stany Zjednoczone, 75231
- Baylor AT&T Memory Center
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Dallas, Texas, Stany Zjednoczone, 75219
- Baylor AT&T Memory Center
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Houston, Texas, Stany Zjednoczone, 77030
- Houston Methodist
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Houston, Texas, Stany Zjednoczone, 77054
- University of Texas Health Services Center - Houston
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San Antonio, Texas, Stany Zjednoczone, 78229
- Clinical Trials of Texas, Inc.
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San Antonio, Texas, Stany Zjednoczone, 78229
- Univ of Texas Health Science Center at San Antonio
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Vermont
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Bennington, Vermont, Stany Zjednoczone, 05201
- The Memory Clinic
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Virginia
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Norfolk, Virginia, Stany Zjednoczone, 23510
- Sentara Medical Group
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Richmond, Virginia, Stany Zjednoczone, 23294
- National Clinical Research - Richmond
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Washington
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Kirkland, Washington, Stany Zjednoczone, 98034
- Evergreen Professional Plaza
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Wisconsin
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Middleton, Wisconsin, Stany Zjednoczone, 53562
- Dean Foundation for Health Research and Education
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Malmö, Szwecja, 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, Szwecja, 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, Szwecja, 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, Szwecja, 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, Tajwan, 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, Tajwan, 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, Tajwan, 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, Tajwan, 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, Tajwan, 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, Tajwan, 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, Tajwan, 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, Tajwan, 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, Tajwan, 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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Genova, Włochy, 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, Włochy, 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, Włochy, 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, Włochy, 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, Włochy, 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, Włochy, 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, Włochy, 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, Włochy, 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, Włochy, 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, Włochy, 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, Włochy, 00189
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bath, Zjednoczone Królestwo, 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, Zjednoczone Królestwo, 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, Zjednoczone Królestwo, 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, Zjednoczone Królestwo, 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, Zjednoczone Królestwo, 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, Zjednoczone Królestwo, 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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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
55 lat do 85 lat (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Liczba ramion
2
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
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Eksperymentalny: Solanezumab
Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.
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Administrowany IV
Inne nazwy:
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Eksperymentalny: Placebo
Placebo given IV once every 4 weeks for up to 2 years.
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Administrowany IV
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Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score
Ramy czasowe: 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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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Sponsor
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
Rozpoczęcie studiów
1 czerwca 2016
Zakończenie podstawowe (Rzeczywisty)
Zakończenie podstawowe
1 maja 2017
Ukończenie studiów (Rzeczywisty)
Ukończenie studiów
1 maja 2017
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
2 maja 2016
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
2 maja 2016
Pierwszy wysłany (Oszacować)
Pierwszy wysłany
3 maja 2016
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
10 października 2019
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
25 września 2019
Ostatnia weryfikacja
Ostatnia weryfikacja
1 września 2019
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- 16349
- H8A-MC-LZBE (Inny identyfikator: Eli Lilly and Company)
- 2016-000108-27 (Numer EudraCT)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu 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.
Ramy czasowe udostępniania 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.
Kryteria dostępu do udostępniania IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- CSR
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .