A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease (ExpeditionPRO)
25 сентября 2019 г. обновлено: 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).
Обзор исследования
Статус
Прекращено
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
26
Фаза
- Фаза 3
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Chemnitz, Германия, 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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Barcelona, Испания, 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, Испания, 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, Испания, 08014
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Castellon de la Plana, Испания, 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, Испания, 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, Испания, 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, Испания, 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, Испания, 10600
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Salt, Испания, 17190
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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San Sebastian, Испания, 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, Испания, 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, Испания, 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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Genova, Италия, 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, Италия, 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, Италия, 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, Италия, 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, Италия, 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, Италия, 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, Италия, 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, Италия, 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, Италия, 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, Италия, 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, Италия, 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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Gatineau, Канада, 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, Канада, 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, Канада, 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, Канада, 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, Канада, 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, Канада, 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, Канада, 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, Канада, 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, Канада, M3B 2S7
- For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
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Białystok, Польша, 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, Польша, 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, Польша, 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, Польша, 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, Польша, 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, Польша, 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, Пуэрто-Рико, 00961-6911
- Santa Cruz Behavioral PSC
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Las Piedras, Пуэрто-Рико, 00771
- Cortex, PSC
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Rio Piedras, Пуэрто-Рико, 00936
- University of Puerto Rico
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San Juan, Пуэрто-Рико, 00918
- Instituto De Neurologia Dra. Ivonne Fraga
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San Juan, Пуэрто-Рико, 00918
- SomniCare Sleep Institute
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San Juan, Пуэрто-Рико, 00918
- Latin Clinical Trial Center
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Bath, Соединенное Королевство, 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, Соединенное Королевство, 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, Соединенное Королевство, 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, Соединенное Королевство, 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, Соединенное Королевство, 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, Соединенное Королевство, 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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Arizona
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Phoenix, Arizona, Соединенные Штаты, 85006
- Banner Alzheimer's Institute
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Phoenix, Arizona, Соединенные Штаты, 85013
- St Josephs Hospital and Medical Center
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Phoenix, Arizona, Соединенные Штаты, 85004
- Xenoscience
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Sun City, Arizona, Соединенные Штаты, 85351
- Banner Sun Health Research Institute
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Tucson, Arizona, Соединенные Штаты, 85718
- Center For Neurosciences
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Tucson, Arizona, Соединенные Штаты, 85724
- Arizona Health Sciences Center
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California
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Glendale, California, Соединенные Штаты, 91206-4140
- Parexel Early Phase Unit at Glendale
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Oxnard, California, Соединенные Штаты, 93030
- Pacific Neuroscience Medical Group
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Rancho Mirage, California, Соединенные Штаты, 92270
- Desert Valley Research
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San Diego, California, Соединенные Штаты, 92123
- Sharp Mesa Vista Hospital
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San Diego, California, Соединенные Штаты, 92103
- Pacific Research Network Inc
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San Francisco, California, Соединенные Штаты, 94114
- California Pacific Medical Center
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Santa Ana, California, Соединенные Штаты, 92705
- Apex Research Institute
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Santa Clarita, California, Соединенные Штаты, 91321
- Care Access Research LLC
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Sherman Oaks, California, Соединенные Штаты, 91403
- California Neuroscience Research
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Valencia, California, Соединенные Штаты, 91355
- Care Access Research
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Colorado
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Colorado Springs, Colorado, Соединенные Штаты, 80910
- MCB Clinical Research Centers
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Denver, Colorado, Соединенные Штаты, 80218
- Mile High Research Center
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Connecticut
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New Haven, Connecticut, Соединенные Штаты, 06510
- Yale University School Of Medicine
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Stamford, Connecticut, Соединенные Штаты, 06905
- New England Institute for Clinical Research
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Delaware
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Newark, Delaware, Соединенные Штаты, 19713
- Christiana Care Research Institute
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Florida
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Delray Beach, Florida, Соединенные Штаты, 33445
- Brain Matters Research
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Fort Myers, Florida, Соединенные Штаты, 33912
- Neuropsychiatric Research Center of Southwest Florida
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Hollywood, Florida, Соединенные Штаты, 33021
- Sunrise Clinical Research
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Jacksonville, Florida, Соединенные Штаты, 32256
- Clinical Neuroscience Solutions Inc
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Miami, Florida, Соединенные Штаты, 33137
- Miami Jewish Health Systems
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Miami Beach, Florida, Соединенные Штаты, 33140
- Mount Sinai Medical Center
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New Port Richey, Florida, Соединенные Штаты, 34652
- Suncoast Clinical Research
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Ocoee, Florida, Соединенные Штаты, 34761
- Sensible Healthcare
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Orlando, Florida, Соединенные Штаты, 32806
- Compass Research
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Pensacola, Florida, Соединенные Штаты, 32502
- Pensacola Research Consultants, Inc.
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Pompano Beach, Florida, Соединенные Штаты, 33064
- Quantum Laboratories
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Sarasota, Florida, Соединенные Штаты, 34243
- Roskamp Institute
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Tampa, Florida, Соединенные Штаты, 33609
- Axiom Research
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West Palm Beach, Florida, Соединенные Штаты, 33407
- Premiere Research Institute at Palm Beach Neurology
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Georgia
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Atlanta, Georgia, Соединенные Штаты, 30331
- Atlanta Center of Medical Research
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Gainesville, Georgia, Соединенные Штаты, 30501
- United Osteoporosis Center
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Illinois
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Champaign, Illinois, Соединенные Штаты, 61820
- Christie Clinic, LLC
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Elk Grove Village, Illinois, Соединенные Штаты, 60007
- Alexian Brothers Medical Center
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Winfield, Illinois, Соединенные Штаты, 60190
- Central DuPage Hospital
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Indiana
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Fort Wayne, Indiana, Соединенные Штаты, 46804
- Fort Wayne Neurological Center
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Indianapolis, Indiana, Соединенные Штаты, 46202
- Indiana University School of Medicine
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Indianapolis, Indiana, Соединенные Штаты, 46256
- Josephson Wallack Munshower Neurology
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Kansas
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Topeka, Kansas, Соединенные Штаты, 66606
- Cotton O'Neil Clinic
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Wichita, Kansas, Соединенные Штаты, 67207
- Heartland Research Associates
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Kentucky
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Lexington, Kentucky, Соединенные Штаты, 40503
- Baptist Health Medical Group
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Louisiana
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Lake Charles, Louisiana, Соединенные Штаты, 70629
- Lake Charles Clinical Trials
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Maine
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Scarborough, Maine, Соединенные Штаты, 04074
- Maine Neurology
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Maryland
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Baltimore, Maryland, Соединенные Штаты, 21285
- Sheppard Pratt Health System
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Baltimore, Maryland, Соединенные Штаты, 21204
- Sheppard Pratt Health System
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Baltimore, Maryland, Соединенные Штаты, 21205
- Johns Hopkins University School Of Medicine
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Baltimore, Maryland, Соединенные Штаты, 21208
- Pharmasite Research Inc
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Massachusetts
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Methuen, Massachusetts, Соединенные Штаты, 01844
- ActivMed Practices & Research, Inc
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Plymouth, Massachusetts, Соединенные Штаты, 02360-4843
- Donald S Marks
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Michigan
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Farmington Hills, Michigan, Соединенные Штаты, 48334
- Quest Research Institute
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Mississippi
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Hattiesburg, Mississippi, Соединенные Штаты, 39401
- Hattiesburg Clinic
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Missouri
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Bolivar, Missouri, Соединенные Штаты, 65613
- Clinvest
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Chesterfield, Missouri, Соединенные Штаты, 63141
- Clinical Research Professionals
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Creve Coeur, Missouri, Соединенные Штаты, 63141
- Millenium Psychiatric Associates LLC
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Kansas City, Missouri, Соединенные Штаты, 64111
- St Lukes Hospital
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Nevada
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Las Vegas, Nevada, Соединенные Штаты, 89113
- Las Vegas Medical Research
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New Hampshire
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Nashua, New Hampshire, Соединенные Штаты, 03060
- Healthy Perspectives Innovative Mental Health Services, PL
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Portsmouth, New Hampshire, Соединенные Штаты, 03801
- ActivMed Practices & Research, Inc
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New Jersey
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Eatontown, New Jersey, Соединенные Штаты, 07724
- Memory Enhancement Center of America, Inc.
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Monroe, New Jersey, Соединенные Штаты, 08831
- Pyramid Clinical Research
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Princeton, New Jersey, Соединенные Штаты, 08540
- Princeton Medical Institute
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Springfield, New Jersey, Соединенные Штаты, 07081
- The Cognitive and Research Center of NJ
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Toms River, New Jersey, Соединенные Штаты, 08755
- Advanced Memory Research Institute of New Jersey
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Toms River, New Jersey, Соединенные Штаты, 08755
- Bio Behavioral Health
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New York
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Albany, New York, Соединенные Штаты, 12206
- Albany Medical College
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Staten Island, New York, Соединенные Штаты, 10312
- Richmond Behavorial Associates
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North Carolina
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Charlotte, North Carolina, Соединенные Штаты, 28270
- Alzheimer's Memory Center
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Winston-Salem, North Carolina, Соединенные Штаты, 27103
- Piedmont Medical Research
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Ohio
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Cincinnati, Ohio, Соединенные Штаты, 45219
- University of Cincinnati Medical Center
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Dayton, Ohio, Соединенные Штаты, 45459
- Neurology Diagnostics, Inc.
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Shaker Heights, Ohio, Соединенные Штаты, 44122
- Insight Clinical Trials
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Oregon
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Portland, Oregon, Соединенные Штаты, 97225
- Center for Cognitive Health
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Portland, Oregon, Соединенные Штаты, 97210
- Summit Research Network Inc
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Pennsylvania
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Abington, Pennsylvania, Соединенные Штаты, 19090
- Abington Neurological Associates
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Allentown, Pennsylvania, Соединенные Штаты, 18104
- Lehigh Center For Clinical Research
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Allentown, Pennsylvania, Соединенные Штаты, 18103
- LeHigh Valley Hospital
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Jenkintown, Pennsylvania, Соединенные Штаты, 19046
- Clinical Trial Center, LLC, Psychiatry
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Plains, Pennsylvania, Соединенные Штаты, 18705
- Northeastern Pennsylvania Memory & Alzheimer's Center
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Rhode Island
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East Providence, Rhode Island, Соединенные Штаты, 02914
- Rhode Island Mood & Memory Research Institute
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Providence, Rhode Island, Соединенные Штаты, 02906
- Butler Hospital
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South Carolina
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Indian Land, South Carolina, Соединенные Штаты, 29707
- Metrolina Neurological Research Institute
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Texas
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Dallas, Texas, Соединенные Штаты, 75231
- FutureSearch Trials
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Dallas, Texas, Соединенные Штаты, 75231
- Baylor AT&T Memory Center
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Dallas, Texas, Соединенные Штаты, 75219
- Baylor AT&T Memory Center
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Houston, Texas, Соединенные Штаты, 77030
- Houston Methodist
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Houston, Texas, Соединенные Штаты, 77054
- University of Texas Health Services Center - Houston
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San Antonio, Texas, Соединенные Штаты, 78229
- Clinical Trials of Texas, Inc.
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San Antonio, Texas, Соединенные Штаты, 78229
- Univ of Texas Health Science Center at San Antonio
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Vermont
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Bennington, Vermont, Соединенные Штаты, 05201
- The Memory Clinic
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Virginia
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Norfolk, Virginia, Соединенные Штаты, 23510
- Sentara Medical Group
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Richmond, Virginia, Соединенные Штаты, 23294
- National Clinical Research - Richmond
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Washington
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Kirkland, Washington, Соединенные Штаты, 98034
- Evergreen Professional Plaza
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Wisconsin
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Middleton, Wisconsin, Соединенные Штаты, 53562
- Dean Foundation for Health Research and Education
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Changhua, Тайвань, 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, Тайвань, 333
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Jhonghe City, Тайвань, 235
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Kaohsiung, Тайвань, 80756
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Kaohsiung, Тайвань, 83301
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Taichung, Тайвань, 40447
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Tainan, Тайвань, 70403
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Taipei, Тайвань, 10048
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Taipei, Тайвань, 11217
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Kuopio, Финляндия, 70210
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Oulu, Финляндия, 90100
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Tampere, Финляндия, 33100
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Turku, Финляндия, 20014
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Vaasa, Финляндия, 65130
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Amiens, Франция, 80054
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Bordeaux, Франция, 33076
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Bron, Франция, 69677
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Lille, Франция, 59037
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Marseille, Франция, 13385
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Montpellier, Франция, 34295
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Paris, Франция, 75015
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Paris, Франция, 75651
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Paris, Франция, 75010
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Rennes, Франция, 35033
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Strasbourg, Франция, 67000
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Toulouse, Франция, 31059
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Malmö, Швеция, 20502
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Mölndal, Швеция, 43141
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Stockholm, Швеция, 113 61
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Umeå, Швеция, 90105
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Bunkyo-ku, Япония, 113-8655
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Bunkyo-ku, Япония, 113-8431
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Hachioji, Япония, 193-0998
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Hyogo, Япония, 673-0848
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Kamakura, Япония, 247-8533
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Kodaira-shi, Япония, 187-8551
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Koriyama, Япония, 963-8052
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Kyoto-shi, Япония, 607-8113
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Mitaka-shi, Япония, 181-0013
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Shinjuku-Ku, Япония, 160-8582
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Shizuoka, Япония, 424-0911
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Takamatsu, Япония, 760-8557
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Tokyo, Япония, 113-0034
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Tsu-shi, Япония, 514-8507
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 55 лет до 85 лет (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
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.)
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Тройной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Solanezumab
Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.
|
Управляется IV
Другие имена:
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Экспериментальный: Placebo
Placebo given IV once every 4 weeks for up to 2 years.
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Управляется IV
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change From Baseline on Alzheimer´s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL)
Временное ограничение: Baseline, 24 Months
|
The ADCS-MCI-ADL is a functional evaluation scale for MCI patients, based on information provided by an informant that describes the performance of participants in several ADLs.
Total score ranges from 0 to 69; lower score indicates greater disease severity.
|
Baseline, 24 Months
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Change From Baseline on the Mini Mental Status Examination (MMSE)
Временное ограничение: 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
|
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Change From Baseline on the Montreal Cognitive Assessment (MoCA)
Временное ограничение: Baseline, 24 Months
|
The MoCA will be used as the global cognitive screening instrument.
It will also be administered in the clinical trial at baseline and the final visits of each phase as a secondary outcome measure of global cognition.
Scores on the MoCA range from 0-30 with 26-30 indicating normal global cognition.
|
Baseline, 24 Months
|
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Change From Baseline on the Functional Activities Questionnaire (FAQ)
Временное ограничение: Baseline, 24 Months
|
FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant's ability to perform a variety of activities ranging from Writing checks, Assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, Traveling out of neighborhood, keeping track of current events and understanding media.
FAQ total score was calculated by adding the scores from each of the 10 items.
Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now = 1; Never did [the activity] but could do now = 0; Normal = 0; Has difficulty but does by self = 1; Requires assistance = 2; Dependent = 3).
The maximum FAQ total score is 30, with higher scores indicating greater impairment.
|
Baseline, 24 Months
|
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Change From Baseline on the Neuropsychiatric Inventory (NPI)
Временное ограничение: Baseline, 24 Months
|
The NPI is a tool for assessing psychopathology in participants with dementia and other neurologic disorders.
Information is obtained from a caregiver familiar with the participant's behavior.
The score ranges from 12 to 144, with higher scores indicating greater disease severity.
|
Baseline, 24 Months
|
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Change From Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)
Временное ограничение: Baseline, 24 Months
|
CDR-SB is a semi-structured interview of participants and their caregivers.
Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care.
Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.
|
Baseline, 24 Months
|
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Change From Baseline on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Временное ограничение: Baseline, 24 Months
|
RBANS is a brief neurocognitive battery with four alternate forms, measuring immediate and delayed memory, attention, language, and visuospatial/constructional skills.
|
Baseline, 24 Months
|
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Change From Baseline on the Free and Cued Selective Reminding Test (FCSRT)
Временное ограничение: 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
|
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Change From Baseline on the Resource Utilization in Dementia-Lite (RUD-Lite)
Временное ограничение: 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
|
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Change From Baseline on the EuroQol 5-Dimensional Health-Related Quality of Life Scale (EQ-5D)
Временное ограничение: 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)
Временное ограничение: 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
|
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Change From Baseline in Concentration of Plasma Amyloid-β Peptide (Aβ) and Plasma Solanezumab
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
|
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Change From Baseline in Neocortical Tau Deposits Using 18F-AV-1451 PET
Временное ограничение: Baseline, 24 Months
|
Biomarker change will be analyzed to provide biomarker-based evidence that solanezumab affects the underlying disease pathology.
|
Baseline, 24 Months
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 июня 2016 г.
Первичное завершение (Действительный)
1 мая 2017 г.
Завершение исследования (Действительный)
1 мая 2017 г.
Даты регистрации исследования
Первый отправленный
2 мая 2016 г.
Впервые представлено, что соответствует критериям контроля качества
2 мая 2016 г.
Первый опубликованный (Оценивать)
3 мая 2016 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
10 октября 2019 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
25 сентября 2019 г.
Последняя проверка
1 сентября 2019 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 16349
- H8A-MC-LZBE (Другой идентификатор: Eli Lilly and Company)
- 2016-000108-27 (Номер EudraCT)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана 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.
Сроки обмена 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.
Критерии совместного доступа к IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- КСО
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .