A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease (ExpeditionPRO)
25 settembre 2019 aggiornato da: 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).
Panoramica dello studio
Stato
Terminato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
26
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Gatineau, Canada, J8T 8J1
- For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
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Greenfield Park, Canada, J4V 2J2
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Halifax, Canada, B3S1M7
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Kentville, Canada, B4N 4K9
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London, Canada, N6C 0A7
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Ottawa, Canada, KIN 5C8
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Peterborough, Canada, K9H2P4
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Sherbrooke, Canada, J1H1Z1
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Toronto, Canada, M3B 2S7
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Kuopio, Finlandia, 70210
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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, Francia, 80054
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Bordeaux, Francia, 33076
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Bron, Francia, 69677
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Lille, Francia, 59037
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Marseille, Francia, 13385
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Montpellier, Francia, 34295
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Paris, Francia, 75015
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Paris, Francia, 75651
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Paris, Francia, 75010
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Rennes, Francia, 35033
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Strasbourg, Francia, 67000
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Toulouse, Francia, 31059
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Chemnitz, Germania, 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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Bunkyo-ku, Giappone, 113-8655
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bunkyo-ku, Giappone, 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, Giappone, 193-0998
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Hyogo, Giappone, 673-0848
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Kamakura, Giappone, 247-8533
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Kodaira-shi, Giappone, 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, Giappone, 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, Giappone, 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, Giappone, 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, Giappone, 160-8582
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Shizuoka, Giappone, 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, Giappone, 760-8557
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tokyo, Giappone, 113-0034
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Tsu-shi, Giappone, 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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Genova, Italia, 16132
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Milano, Italia, 20122
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Milano, Italia, 20133
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Monza, Italia, 20052
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pavia, Italia, 27100
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Perugia, Italia, 06134
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pisa, Italia, 56126
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Roma, Italia, 00161
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Roma, Italia, 00153
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Roma, Italia, 00179
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Roma, Italia, 00189
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Białystok, Polonia, 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, Polonia, 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, Polonia, 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, Polonia, 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, Polonia, 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, Polonia, 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, Porto Rico, 00961-6911
- Santa Cruz Behavioral PSC
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Las Piedras, Porto Rico, 00771
- Cortex, PSC
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Rio Piedras, Porto Rico, 00936
- University of Puerto Rico
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San Juan, Porto Rico, 00918
- Instituto De Neurologia Dra. Ivonne Fraga
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San Juan, Porto Rico, 00918
- SomniCare Sleep Institute
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San Juan, Porto Rico, 00918
- Latin Clinical Trial Center
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Bath, Regno Unito, 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, Regno Unito, W6 8RF
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Guildford, Regno Unito, GU2 7YD
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London, Regno Unito, 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, Regno Unito, M13 9WL
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Scotland, Regno Unito, G20 0XA
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Barcelona, Spagna, 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, Spagna, 08036
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Barcelona, Spagna, 08014
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Castellon de la Plana, Spagna, 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, Spagna, 28905
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Getxo, Spagna, 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, Spagna, 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, Spagna, 10600
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Salt, Spagna, 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, Spagna, 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, Spagna, 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, Spagna, 46026
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Arizona
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Phoenix, Arizona, Stati Uniti, 85006
- Banner Alzheimer's Institute
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Phoenix, Arizona, Stati Uniti, 85013
- St Josephs Hospital and Medical Center
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Phoenix, Arizona, Stati Uniti, 85004
- Xenoscience
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Sun City, Arizona, Stati Uniti, 85351
- Banner Sun Health Research Institute
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Tucson, Arizona, Stati Uniti, 85718
- Center for Neurosciences
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Tucson, Arizona, Stati Uniti, 85724
- Arizona Health Sciences Center
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California
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Glendale, California, Stati Uniti, 91206-4140
- Parexel Early Phase Unit at Glendale
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Oxnard, California, Stati Uniti, 93030
- Pacific Neuroscience Medical Group
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Rancho Mirage, California, Stati Uniti, 92270
- Desert Valley Research
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San Diego, California, Stati Uniti, 92123
- Sharp Mesa Vista Hospital
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San Diego, California, Stati Uniti, 92103
- Pacific Research Network Inc
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San Francisco, California, Stati Uniti, 94114
- California Pacific Medical Center
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Santa Ana, California, Stati Uniti, 92705
- Apex Research Institute
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Santa Clarita, California, Stati Uniti, 91321
- Care Access Research LLC
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Sherman Oaks, California, Stati Uniti, 91403
- California Neuroscience Research
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Valencia, California, Stati Uniti, 91355
- Care Access Research
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Colorado
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Colorado Springs, Colorado, Stati Uniti, 80910
- MCB Clinical Research Centers
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Denver, Colorado, Stati Uniti, 80218
- Mile High Research Center
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Connecticut
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New Haven, Connecticut, Stati Uniti, 06510
- Yale University School of Medicine
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Stamford, Connecticut, Stati Uniti, 06905
- New England Institute for Clinical Research
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Delaware
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Newark, Delaware, Stati Uniti, 19713
- Christiana Care Research Institute
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Florida
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Delray Beach, Florida, Stati Uniti, 33445
- Brain Matters Research
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Fort Myers, Florida, Stati Uniti, 33912
- Neuropsychiatric Research Center of Southwest Florida
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Hollywood, Florida, Stati Uniti, 33021
- Sunrise Clinical Research
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Jacksonville, Florida, Stati Uniti, 32256
- Clinical NeuroScience Solutions Inc
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Miami, Florida, Stati Uniti, 33137
- Miami Jewish Health Systems
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Miami Beach, Florida, Stati Uniti, 33140
- Mount Sinai Medical Center
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New Port Richey, Florida, Stati Uniti, 34652
- Suncoast Clinical Research
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Ocoee, Florida, Stati Uniti, 34761
- Sensible Healthcare
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Orlando, Florida, Stati Uniti, 32806
- Compass Research
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Pensacola, Florida, Stati Uniti, 32502
- Pensacola Research Consultants, Inc.
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Pompano Beach, Florida, Stati Uniti, 33064
- Quantum Laboratories
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Sarasota, Florida, Stati Uniti, 34243
- Roskamp Institute
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Tampa, Florida, Stati Uniti, 33609
- Axiom Research
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West Palm Beach, Florida, Stati Uniti, 33407
- Premiere Research Institute at Palm Beach Neurology
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Georgia
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Atlanta, Georgia, Stati Uniti, 30331
- Atlanta Center of Medical Research
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Gainesville, Georgia, Stati Uniti, 30501
- United Osteoporosis Center
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Illinois
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Champaign, Illinois, Stati Uniti, 61820
- Christie Clinic, LLC
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Elk Grove Village, Illinois, Stati Uniti, 60007
- Alexian Brothers Medical Center
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Winfield, Illinois, Stati Uniti, 60190
- Central DuPage Hospital
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Indiana
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Fort Wayne, Indiana, Stati Uniti, 46804
- Fort Wayne Neurological Center
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Indianapolis, Indiana, Stati Uniti, 46202
- Indiana University School of Medicine
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Indianapolis, Indiana, Stati Uniti, 46256
- Josephson Wallack Munshower Neurology
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-
Kansas
-
Topeka, Kansas, Stati Uniti, 66606
- Cotton O'Neil Clinic
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Wichita, Kansas, Stati Uniti, 67207
- Heartland Research Associates
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-
Kentucky
-
Lexington, Kentucky, Stati Uniti, 40503
- Baptist Health Medical Group
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-
Louisiana
-
Lake Charles, Louisiana, Stati Uniti, 70629
- Lake Charles Clinical Trials
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-
Maine
-
Scarborough, Maine, Stati Uniti, 04074
- Maine Neurology
-
-
Maryland
-
Baltimore, Maryland, Stati Uniti, 21285
- Sheppard Pratt Health System
-
Baltimore, Maryland, Stati Uniti, 21204
- Sheppard Pratt Health System
-
Baltimore, Maryland, Stati Uniti, 21205
- Johns Hopkins University School of Medicine
-
Baltimore, Maryland, Stati Uniti, 21208
- Pharmasite Research Inc
-
-
Massachusetts
-
Methuen, Massachusetts, Stati Uniti, 01844
- ActivMed Practices & Research, Inc
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Plymouth, Massachusetts, Stati Uniti, 02360-4843
- Donald S Marks
-
-
Michigan
-
Farmington Hills, Michigan, Stati Uniti, 48334
- Quest Research Institute
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-
Mississippi
-
Hattiesburg, Mississippi, Stati Uniti, 39401
- Hattiesburg Clinic
-
-
Missouri
-
Bolivar, Missouri, Stati Uniti, 65613
- Clinvest
-
Chesterfield, Missouri, Stati Uniti, 63141
- Clinical Research Professionals
-
Creve Coeur, Missouri, Stati Uniti, 63141
- Millenium Psychiatric Associates LLC
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Kansas City, Missouri, Stati Uniti, 64111
- St Lukes Hospital
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-
Nevada
-
Las Vegas, Nevada, Stati Uniti, 89113
- Las Vegas Medical Research
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-
New Hampshire
-
Nashua, New Hampshire, Stati Uniti, 03060
- Healthy Perspectives Innovative Mental Health Services, PL
-
Portsmouth, New Hampshire, Stati Uniti, 03801
- ActivMed Practices & Research, Inc
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-
New Jersey
-
Eatontown, New Jersey, Stati Uniti, 07724
- Memory Enhancement Center of America, Inc.
-
Monroe, New Jersey, Stati Uniti, 08831
- Pyramid Clinical Research
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Princeton, New Jersey, Stati Uniti, 08540
- Princeton Medical Institute
-
Springfield, New Jersey, Stati Uniti, 07081
- The Cognitive and Research Center of NJ
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Toms River, New Jersey, Stati Uniti, 08755
- Advanced Memory Research Institute of New Jersey
-
Toms River, New Jersey, Stati Uniti, 08755
- Bio Behavioral Health
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-
New York
-
Albany, New York, Stati Uniti, 12206
- Albany Medical College
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Staten Island, New York, Stati Uniti, 10312
- Richmond Behavorial Associates
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-
North Carolina
-
Charlotte, North Carolina, Stati Uniti, 28270
- Alzheimer's Memory Center
-
Winston-Salem, North Carolina, Stati Uniti, 27103
- Piedmont Medical Research
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-
Ohio
-
Cincinnati, Ohio, Stati Uniti, 45219
- University of Cincinnati Medical Center
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Dayton, Ohio, Stati Uniti, 45459
- Neurology Diagnostics, Inc.
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Shaker Heights, Ohio, Stati Uniti, 44122
- Insight Clinical Trials
-
-
Oregon
-
Portland, Oregon, Stati Uniti, 97225
- Center for Cognitive Health
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Portland, Oregon, Stati Uniti, 97210
- Summit Research Network Inc
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-
Pennsylvania
-
Abington, Pennsylvania, Stati Uniti, 19090
- Abington Neurological Associates
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Allentown, Pennsylvania, Stati Uniti, 18104
- Lehigh Center for Clinical Research
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Allentown, Pennsylvania, Stati Uniti, 18103
- LeHigh Valley Hospital
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Jenkintown, Pennsylvania, Stati Uniti, 19046
- Clinical Trial Center, LLC, Psychiatry
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Plains, Pennsylvania, Stati Uniti, 18705
- Northeastern Pennsylvania Memory & Alzheimer's Center
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Rhode Island
-
East Providence, Rhode Island, Stati Uniti, 02914
- Rhode Island Mood & Memory Research Institute
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Providence, Rhode Island, Stati Uniti, 02906
- Butler Hospital
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-
South Carolina
-
Indian Land, South Carolina, Stati Uniti, 29707
- Metrolina Neurological Research Institute
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-
Texas
-
Dallas, Texas, Stati Uniti, 75231
- FutureSearch Trials
-
Dallas, Texas, Stati Uniti, 75231
- Baylor AT&T Memory Center
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Dallas, Texas, Stati Uniti, 75219
- Baylor AT&T Memory Center
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Houston, Texas, Stati Uniti, 77030
- Houston Methodist
-
Houston, Texas, Stati Uniti, 77054
- University of Texas Health Services Center - Houston
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San Antonio, Texas, Stati Uniti, 78229
- Clinical Trials of Texas, Inc.
-
San Antonio, Texas, Stati Uniti, 78229
- Univ of Texas Health Science Center at San Antonio
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-
Vermont
-
Bennington, Vermont, Stati Uniti, 05201
- The Memory Clinic
-
-
Virginia
-
Norfolk, Virginia, Stati Uniti, 23510
- Sentara Medical Group
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Richmond, Virginia, Stati Uniti, 23294
- National Clinical Research - Richmond
-
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Washington
-
Kirkland, Washington, Stati Uniti, 98034
- Evergreen Professional Plaza
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-
Wisconsin
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Middleton, Wisconsin, Stati Uniti, 53562
- Dean Foundation for Health Research and Education
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-
-
-
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Malmö, Svezia, 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, Svezia, 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, Svezia, 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, Svezia, 90105
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
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Changhua, Taiwan, 500
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Gwei Shan Township, Taiwan, 333
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Jhonghe City, Taiwan, 235
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Kaohsiung, Taiwan, 80756
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Kaohsiung, Taiwan, 83301
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Taichung, Taiwan, 40447
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Tainan, Taiwan, 70403
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Taipei, Taiwan, 10048
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Taipei, Taiwan, 11217
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 55 anni a 85 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Solanezumab
Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.
|
Amministrato IV
Altri nomi:
|
|
Sperimentale: Placebo
Placebo given IV once every 4 weeks for up to 2 years.
|
Amministrato IV
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change From Baseline on Alzheimer´s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL)
Lasso di tempo: Baseline, 24 Months
|
The ADCS-MCI-ADL is a functional evaluation scale for MCI patients, based on information provided by an informant that describes the performance of participants in several ADLs.
Total score ranges from 0 to 69; lower score indicates greater disease severity.
|
Baseline, 24 Months
|
|
Change From Baseline on the Mini Mental Status Examination (MMSE)
Lasso di tempo: Baseline, 24 Months
|
MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants.Total score ranges from 0 to 30; lower score indicates greater disease severity.
|
Baseline, 24 Months
|
|
Change From Baseline on the Montreal Cognitive Assessment (MoCA)
Lasso di tempo: Baseline, 24 Months
|
The MoCA will be used as the global cognitive screening instrument.
It will also be administered in the clinical trial at baseline and the final visits of each phase as a secondary outcome measure of global cognition.
Scores on the MoCA range from 0-30 with 26-30 indicating normal global cognition.
|
Baseline, 24 Months
|
|
Change From Baseline on the Functional Activities Questionnaire (FAQ)
Lasso di tempo: Baseline, 24 Months
|
FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant's ability to perform a variety of activities ranging from Writing checks, Assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, Traveling out of neighborhood, keeping track of current events and understanding media.
FAQ total score was calculated by adding the scores from each of the 10 items.
Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now = 1; Never did [the activity] but could do now = 0; Normal = 0; Has difficulty but does by self = 1; Requires assistance = 2; Dependent = 3).
The maximum FAQ total score is 30, with higher scores indicating greater impairment.
|
Baseline, 24 Months
|
|
Change From Baseline on the Neuropsychiatric Inventory (NPI)
Lasso di tempo: Baseline, 24 Months
|
The NPI is a tool for assessing psychopathology in participants with dementia and other neurologic disorders.
Information is obtained from a caregiver familiar with the participant's behavior.
The score ranges from 12 to 144, with higher scores indicating greater disease severity.
|
Baseline, 24 Months
|
|
Change From Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)
Lasso di tempo: Baseline, 24 Months
|
CDR-SB is a semi-structured interview of participants and their caregivers.
Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care.
Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.
|
Baseline, 24 Months
|
|
Change From Baseline on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Lasso di tempo: Baseline, 24 Months
|
RBANS is a brief neurocognitive battery with four alternate forms, measuring immediate and delayed memory, attention, language, and visuospatial/constructional skills.
|
Baseline, 24 Months
|
|
Change From Baseline on the Free and Cued Selective Reminding Test (FCSRT)
Lasso di tempo: Baseline, 24 Months
|
The FCSRT is a neuropsychological test of memory under conditions that control attention and cognitive processing in order to obtain an assessment of memory unconfounded by normal age-related changes in cognition.
|
Baseline, 24 Months
|
|
Change From Baseline on the Resource Utilization in Dementia-Lite (RUD-Lite)
Lasso di tempo: Baseline, 24 Months
|
RUD-Lite assesses the healthcare resource utilization of participants and their caregivers to determine the level of formal and informal care attributable to Alzheimer's Disease (AD).
Information on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) is collected from the baseline and follow-up interviews.
|
Baseline, 24 Months
|
|
Change From Baseline on the EuroQol 5-Dimensional Health-Related Quality of Life Scale (EQ-5D)
Lasso di tempo: 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)
Lasso di tempo: Baseline, 24 Months
|
QoL for AD assess participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment.
Each of 13 items rated on a 4-point scale.
Sum of items=total score (range: 13-52).
Higher scores=greater QoL.
|
Baseline, 24 Months
|
|
Change From Baseline in Concentration of Plasma Amyloid-β Peptide (Aβ) and Plasma Solanezumab
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Baseline, 24 Months
|
Changes in CSF parameters, including total and free Aβ1-40 and Aβ1-42 species and total tau and P-tau181 peptides, will be assessed.
|
Baseline, 24 Months
|
|
Change From Baseline in Neocortical Tau Deposits Using 18F-AV-1451 PET
Lasso di tempo: Baseline, 24 Months
|
Biomarker change will be analyzed to provide biomarker-based evidence that solanezumab affects the underlying disease pathology.
|
Baseline, 24 Months
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 giugno 2016
Completamento primario (Effettivo)
1 maggio 2017
Completamento dello studio (Effettivo)
1 maggio 2017
Date di iscrizione allo studio
Primo inviato
2 maggio 2016
Primo inviato che soddisfa i criteri di controllo qualità
2 maggio 2016
Primo Inserito (Stima)
3 maggio 2016
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
10 ottobre 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
25 settembre 2019
Ultimo verificato
1 settembre 2019
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 16349
- H8A-MC-LZBE (Altro identificatore: Eli Lilly and Company)
- 2016-000108-27 (Numero EudraCT)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano 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.
Periodo di condivisione 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.
Criteri di accesso alla condivisione IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- RSI
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .