Continued Safety Monitoring of Solanezumab (LY2062430) in Alzheimer's Disease (EXPEDITION EXT)
2019年9月25日 更新者：Eli Lilly and Company
Continued Efficacy and Safety Monitoring of Solanezumab, an Anti-Amyloid β Antibody in Patients With Alzheimer's Disease
This study is an open-label extension study in Alzheimer's patients who have completed participation in either solanezumab Clinical Trial H8A-MC-LZAM (NCT00905372) or H8A-MC-LZAN (NCT00904683).
研究概览
研究类型
介入性
注册 (实际的)
1457
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Chelyabinsk、俄罗斯联邦、454091
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Saint Petersburg、俄罗斯联邦、190021
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Alberta
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Medicine Hat、Alberta、加拿大、T1B4E7
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British Columbia
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Kelowna、British Columbia、加拿大、V1Y3G5
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Penticton、British Columbia、加拿大、V2A 5C8
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Ontario
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Ottawa、Ontario、加拿大、K1N 5C8
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Toronto、Ontario、加拿大、M6M 3Z5
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Quebec
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Greenfield Park、Quebec、加拿大、J4V 2J2
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Sherbrooke、Quebec、加拿大、J1H1Z1
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Guishan、台湾、33305
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Niaosong、台湾、833
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Taipei、台湾、112
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Incheon、大韩民国、400-711
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Seongnam-Si、大韩民国、463-707
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Seoul、大韩民国、143-729
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Suwon-Si、大韩民国、443-721
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Curitiba、巴西、80060-900
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Itapira、巴西、13970-905
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Porto Alegre、巴西、90110-270
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Rio De Janeiro、巴西、22271-100
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São Paulo、巴西、04024-002
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Berlin、德国、12203
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Hamburg、德国、22307
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Hannover、德国、30559
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Mannheim、德国、68165
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Munich、德国、D-81675
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Regensburg、德国、93042
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Baggiovara、意大利、41100
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Biella、意大利、13900
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Chieti、意大利、66013
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Genova、意大利、16128
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Lido Di Camaiore、意大利、55043
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Milano、意大利、20132
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Rome、意大利、00186
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Aichi、日本、474-8511
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Ehime、日本、791-0295
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Fukuoka、日本、816-0864
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Hiroshima、日本、720-0825
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Hyogo、日本、514-8507
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Kanagawa、日本、247-8533
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Kyoto、日本、607-8062
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Osaka、日本、545-8586
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Shizuoka、日本、424-0911
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Tokyo、日本、187-8551
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Paris、法国、75475
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Rennes、法国、35000
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Strasbourg、法国、67091
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Toulouse、法国、31300
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Bydgoszcz、波兰、85-796
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Gliwice、波兰、44-100
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Katowice、波兰、40-588
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Krakow、波兰、31-530
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Lublin、波兰、20-954
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Warsaw、波兰、01-211
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New South Wales
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Gosford、New South Wales、澳大利亚、2250
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Kogarah、New South Wales、澳大利亚、2217
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Queensland
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Chermside、Queensland、澳大利亚、4032
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Toowoomba、Queensland、澳大利亚、4650
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Victoria
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Box Hill、Victoria、澳大利亚、3128
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Glen Iris、Victoria、澳大利亚、3146
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Heidelberg Heights、Victoria、澳大利亚、3081
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Melbourne、Victoria、澳大利亚、3004
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Western Australia
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Subiaco、Western Australia、澳大利亚、6008
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Jönköping、瑞典、551 85
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Kalmar、瑞典、39185
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Lund、瑞典、22241
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Molndal、瑞典、43135
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Umea、瑞典、901 85
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Arizona
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Phoenix、Arizona、美国、85006
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Sun City、Arizona、美国、85351
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Tucson、Arizona、美国、85718
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Arkansas
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Little Rock、Arkansas、美国、72211
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California
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Carson、California、美国、90746
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Laguna Hills、California、美国、92653
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Lomita、California、美国、90717
- 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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Los Angeles、California、美国、90073
- 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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Oxnard、California、美国、93030
- 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 Diego、California、美国、92103
- 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 Francisco、California、美国、94109
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Santa Ana、California、美国、92705
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Santa Monica、California、美国、90404
- 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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Colorado
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Denver、Colorado、美国、80239
- 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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Connecticut
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Fairfield、Connecticut、美国、06824
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Hamden、Connecticut、美国、06518
- 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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New Haven、Connecticut、美国、06510
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Norwalk、Connecticut、美国、06851
- 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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Delaware
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Newark、Delaware、美国、19713
- 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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District of Columbia
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Washington、District of Columbia、美国、20057
- 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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Florida
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Boca Raton、Florida、美国、33431
- 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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Fort Myers、Florida、美国、33912
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Hollywood、Florida、美国、33021
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Miami、Florida、美国、33137
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Miami Springs、Florida、美国、33166
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Orange City、Florida、美国、32763
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Orlando、Florida、美国、32806
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Sunrise、Florida、美国、33351
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Tampa、Florida、美国、33613
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Georgia
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Atlanta、Georgia、美国、30341
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Canton、Georgia、美国、30114
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Decatur、Georgia、美国、30033
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Indiana
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Indianapolis、Indiana、美国、46202
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Kentucky
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Lexington、Kentucky、美国、40503
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Maryland
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Baltimore、Maryland、美国、21285
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Rockville、Maryland、美国、20852
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Massachusetts
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Belmont、Massachusetts、美国、02478
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Michigan
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Traverse City、Michigan、美国、49684
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Missouri
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Creve Coeur、Missouri、美国、63141
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New Mexico
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Albuquerque、New Mexico、美国、87109
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New York
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Albany、New York、美国、12205
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Amherst、New York、美国、14226
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Brooklyn、New York、美国、11235
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Latham、New York、美国、12210
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New York、New York、美国、10032
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Staten Island、New York、美国、10312
- 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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North Carolina
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Raleigh、North Carolina、美国、27607
- 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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Winston-Salem、North Carolina、美国、27103
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Ohio
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Beachwood、Ohio、美国、44122
- 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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Toledo、Ohio、美国、43623
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Oklahoma
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Oklahoma City、Oklahoma、美国、73116
- 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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Oregon
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Eugene、Oregon、美国、97401
- 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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Portland、Oregon、美国、97210
- 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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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- 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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Rhode Island
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East Providence、Rhode Island、美国、02914
- 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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South Carolina
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Charleston、South Carolina、美国、29425
- 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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Greer、South Carolina、美国、29650
- 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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South Dakota
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Sioux Falls、South Dakota、美国、57105
- 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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Utah
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Salt Lake City、Utah、美国、84108
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Vermont
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Bennington、Vermont、美国、05201
- 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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Burlington、Vermont、美国、05401
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Virginia
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Norfolk、Virginia、美国、23502
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Roanoke、Virginia、美国、24018
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Washington
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Seattle、Washington、美国、98108
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E Susx
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Uckfield、E Susx、英国、TN225AW
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Glasgow
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Scotland、Glasgow、英国、G20 0XA
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Greater London
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London、Greater London、英国、N195NX
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London
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Camberwell、London、英国、SE5 8AF
- 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、西班牙、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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Getafe、西班牙、28905
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Madrid、西班牙、28006
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Plasencia、西班牙、10600
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Terrassa、西班牙、08221
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Buenos Aires、阿根廷、CBA 1419
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Ciudad Automona De Buenos Aire、阿根廷、C1111AAL
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Cordoba、阿根廷、X5004AOA
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Mendoza、阿根廷、5500
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Rosario、阿根廷、S2000BZL
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Santa Fe、阿根廷、S3000FWO
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
55年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's Disease
- Has completed participation in solanezumab Study LZAM or Study LZAN through 80 weeks
- Must continue to have a reliable caregiver who is in frequent contact with the patient for the entire study
- Must have good vein access to administer infusions
- Agrees not to participate in studies of any other investigational compounds for the duration of their participation in Study LZAO
Exclusion Criteria:
- Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- Meets LZAM or LZAN discontinuation criteria at the end of treatment in LZAM or LZAN study
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：安慰剂
|
Participants were from feeder studies (LZAM or LZAN).
Placebo administered intravenously every 4 weeks through Week 80.
|
|
实验性的：Solanezumab
|
400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Assess the Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)
大体时间：Baseline through Week 104
|
The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively.
In addition, the number of participants with 1 or more serious AEs is summarized cumulatively.
A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason.
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
|
Baseline through Week 104
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive 14-Item Scale (ADAS-Cog14)
大体时间：Baseline, Week 104
|
ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures.
A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90.
Higher scores indicate greater disease severity.
Least Squares (LS) Mean was determined by mixed model repeated measures (MMRM) methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 Mini-Mental State Examination (MMSE) status (mild/moderate), concomitant acetylcholinesterase inhibitors (AChEI)/Memantine use at baseline (yes/no), baseline age and treatment*visit.
|
Baseline, Week 104
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Change From Baseline to 104-week Endpoint in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)
大体时间：Baseline, Week 104
|
ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant's caregiver.
It measures performance of basic and instrumental activities of daily living by participants.
The total score ranges from 0 to 78, with lower scores indicating greater disease severity.
LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
|
Baseline, Week 104
|
|
Change From Baseline to 104-week Endpoint in Clinical Dementia Rating - Sum of Boxes (CDR-SB)
大体时间：Baseline, Week 104
|
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.
LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
|
Baseline, Week 104
|
|
Change From Baseline to 104-week Endpoint in Neuropsychiatric Inventory (NPI)
大体时间：Baseline, Week 104
|
The NPI is a questionnaire administered to caregivers that quantifies behavioral changes in dementia.
Each of the 12 behavioral domains the caregiver reports as present are scored for Frequency, scale: 1 (Occasionally) to 4 (Very Frequently), and Severity, scale: 1 (Mild) to 3 (Severe).
If the domain is reported by the caregiver as 'Not Affected,' that domain is scored as 0. The individual domain scores are calculated by multiplying the frequency times the severity for each domain.
NPI Total Score is calculated by adding the individual domain scores together for all 12 domains, with a scores range from 0 to 144.
Lower scores indicated less severity and higher scores indicated a greater severity of neuropsychiatric disturbance.
LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
|
Baseline, Week 104
|
|
Change From Baseline to 104-week Endpoint in Resource Utilization in Dementia - Lite (RUD-Lite) Caregiver Hours
大体时间：Baseline, Week 104
|
The RUD-Lite is a caregiver-completed assessment designed to assess the amount of formal and informal resources used by participants and the primary caregiver.
It is completed by the caregiver and compiles data on the following resources: length of time the caregiver spends giving care, assisting participants with basic activities of daily living (BADL: eating dressing, grooming, bathing); assisting participants with instrumental activities of daily living (IADLs: shopping, cooking, housekeeping, laundry, transportation, taking medication, managing finances), and providing supervision.
Scores range from 0 to 24 hours.
Higher values indicate greater resource use.
LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
|
Baseline, Week 104
|
|
Change From Baseline to 104-week Endpoint in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy)
大体时间：Baseline, Week 104
|
EQ-5D (proxy version) is a generic, multidimensional, health-related, quality-of-life instrument assessing caregiver's impression of participants overall health state.
Profile allows caregivers to rate participant's health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale: 1 (no problem), 2 (some problems), and 3 (major problems).
These attribute combinations are converted into a weighted Health-State Index Score according to the United States (US) population-based algorithm.
EQ-5D US Population-Based Index Scores range from -0.11 to 1.0.
A score of 1.0 indicated perfect health.
The Overall Health State Index Score is caregiver-reported using a visual analogue scale marked 0 (worst imaginable health) to 100 (best imaginable health state).
LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
|
Baseline, Week 104
|
|
Change From Baseline to 104-week Endpoint in Quality of Life in Alzheimer's Disease (QoL-AD)
大体时间：Baseline, Week 104
|
The QoL-AD (Caregiver Total Score) is a disease-specific measure of quality of life for an Alzheimer's Disease (AD) population administered to the participant's primary caregiver, who answers on behalf of the participant.
The assessment consists of 13 items covering physical health, energy, mood, living situations, memory, family, marriage, friends, chores, fun, money, self and life as a whole.
The assessment is scored on a 4-point Likert scale with scores ranging from 1 (poor) to 4 (excellent).
QoL-AD Total Score is defined as the sum of the 13 items with a scores range from 13 to 52.
Higher scores denote a better quality of life.
LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
|
Baseline, Week 104
|
|
Change From Baseline to 104-week Endpoint in Mini-Mental State Examination (MMSE)
大体时间：Baseline, Week 104
|
The MMSE is an instrument used to assess a participant's cognitive function.
The instrument is divided into 2 sections.
The first section measures orientation, memory, and attention with scores ranging from 0 to 21 (lower scores indicate greater impairment).
The second section tests the ability of the participant to name objects, follow verbal and written commands, write a sentence, and copy figures with scores ranging from 0 to 9 (lower scores indicate greater impairment).
The range for MMSE Total Score is 0 to 30.
Lower scores indicate more impairment.
LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
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Baseline, Week 104
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Change From Baseline to 52-week Endpoint in Plasma Amyloid Beta (Aβ) Levels
大体时间：Baseline, Week 52
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Concentration of the peptide Aβ 1-40 and Aβ 1-42 in plasma measured by immunoassay.
The immunoassays for plasma Aβ 1-40 and Aβ 1-42 peptides were modified to render them tolerant to the presence of Solanezumab which would otherwise interfere with non-modified assays.
LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
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Baseline, Week 52
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Change From Baseline to 104-week Endpoint in Volumetric Magnetic Resonance Imaging (vMRI)
大体时间：Baseline, Week 104
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The vMRI assessment of right and left hippocampal volume is reported.
LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
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Baseline, Week 104
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Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive Subscore 11-Item Scale (ADAS-Cog11)
大体时间：Baseline, Week 104
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The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease: orientation, verbal memory, language, and praxis.
The scale ranges from 0 to 70, with higher scores indicating greater disease severity.
LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment*visit.
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Baseline, Week 104
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Mean Change From Baseline to Endpoint in Amyloid Imaging Parameters in Subjects With Mild Alzheimer's Disease
大体时间：Baseline, Week 104
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Florbetapir PET imaging was used to test for change from baseline.
The hypothesis that amyloid burden was reduced in participants between the treatment groups from the feeder studies was tested.
The change from baseline to the postbaseline visit of the composite summary standard uptake value ratio of florbetapir F18 was calculated.
The composite summary measure is an unweighted average of the 6 smaller regions (anterior cingulate, frontal medial orbital, parietal, posterior cingulate, precuneus, and temporal) normalized to whole cerebellum and to subject-specific white matter.
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Baseline, Week 104
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年12月1日
初级完成 (实际的)
2014年7月1日
研究完成 (实际的)
2017年2月1日
研究注册日期
首次提交
2010年5月19日
首先提交符合 QC 标准的
2010年5月19日
首次发布 (估计)
2010年5月21日
研究记录更新
最后更新发布 (实际的)
2019年10月8日
上次提交的符合 QC 标准的更新
2019年9月25日
最后验证
2019年9月1日
更多信息
与本研究相关的术语
其他研究编号
- 11935 (注册表标识符：DAIDS ES Registry Number)
- H8A-MC-LZAO (其他标识符：Eli Lilly and Company)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD 共享时间框架
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later.
Data will be indefinitely available for requesting.
IPD 共享访问标准
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD 共享支持信息类型
- 研究方案
- 树液
- 企业社会责任
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Solanezumab的临床试验
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Eli Lilly and CompanyAlzheimer's Therapeutic Research Institute完全的
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Eli Lilly and Company终止阿尔茨海默氏病意大利, 美国, 西班牙, 台湾, 法国, 日本, 波多黎各, 波兰, 瑞典, 芬兰, 加拿大, 英国, 德国
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Washington University School of MedicineEli Lilly and Company; Hoffmann-La Roche; Avid Radiopharmaceuticals; National Institute on Aging... 和其他合作者完全的失智 | 阿尔茨海默氏病 | 阿尔茨海默病，家族性美国, 加拿大, 法国, 西班牙, 爱尔兰, 澳大利亚, 波多黎各, 英国
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Eli Lilly and Company终止阿尔茨海默氏病美国, 意大利, 法国, 日本, 澳大利亚, 德国, 西班牙, 瑞典, 加拿大, 波兰, 英国
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Washington University School of MedicineEli Lilly and Company; Hoffmann-La Roche; Avid Radiopharmaceuticals; National Institute on Aging... 和其他合作者招聘中失智 | 阿尔茨海默氏病 | 阿尔茨海默病，家族性美国, 加拿大, 意大利, 阿根廷, 澳大利亚, 巴西, 哥伦比亚, 法国, 德国, 爱尔兰, 日本, 墨西哥, 荷兰, 波多黎各, 西班牙, 英国
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Eli Lilly and Company完全的阿尔茨海默氏病美国, 阿根廷, 巴西, 日本, 加拿大
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Eli Lilly and Company完全的阿尔茨海默氏病西班牙, 美国, 法国, 大韩民国, 日本, 澳大利亚, 台湾, 瑞典, 德国, 意大利, 波兰, 俄罗斯联邦, 英国