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).
調査の概要
研究の種類
介入
入学 (実際)
1457
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Arizona
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Phoenix、Arizona、アメリカ、85006
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Sun City、Arizona、アメリカ、85351
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Tucson、Arizona、アメリカ、85718
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Arkansas
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Little Rock、Arkansas、アメリカ、72211
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California
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Carson、California、アメリカ、90746
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Laguna Hills、California、アメリカ、92653
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Lomita、California、アメリカ、90717
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Los Angeles、California、アメリカ、90073
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Oxnard、California、アメリカ、93030
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San Diego、California、アメリカ、92103
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San Francisco、California、アメリカ、94109
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Santa Ana、California、アメリカ、92705
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Santa Monica、California、アメリカ、90404
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Colorado
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Denver、Colorado、アメリカ、80239
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Connecticut
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Fairfield、Connecticut、アメリカ、06824
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Hamden、Connecticut、アメリカ、06518
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New Haven、Connecticut、アメリカ、06510
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Norwalk、Connecticut、アメリカ、06851
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Delaware
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Newark、Delaware、アメリカ、19713
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District of Columbia
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Washington、District of Columbia、アメリカ、20057
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Florida
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Boca Raton、Florida、アメリカ、33431
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Fort Myers、Florida、アメリカ、33912
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Hollywood、Florida、アメリカ、33021
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Miami、Florida、アメリカ、33137
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Miami Springs、Florida、アメリカ、33166
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Orange City、Florida、アメリカ、32763
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Orlando、Florida、アメリカ、32806
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Sunrise、Florida、アメリカ、33351
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Tampa、Florida、アメリカ、33613
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Georgia
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Atlanta、Georgia、アメリカ、30341
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Canton、Georgia、アメリカ、30114
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Decatur、Georgia、アメリカ、30033
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Indiana
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Indianapolis、Indiana、アメリカ、46202
- 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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Kentucky
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Lexington、Kentucky、アメリカ、40503
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Maryland
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Baltimore、Maryland、アメリカ、21285
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Rockville、Maryland、アメリカ、20852
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Massachusetts
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Belmont、Massachusetts、アメリカ、02478
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Michigan
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Traverse City、Michigan、アメリカ、49684
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Missouri
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Creve Coeur、Missouri、アメリカ、63141
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New Mexico
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Albuquerque、New Mexico、アメリカ、87109
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New York
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Albany、New York、アメリカ、12205
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Amherst、New York、アメリカ、14226
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Brooklyn、New York、アメリカ、11235
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Latham、New York、アメリカ、12210
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New York、New York、アメリカ、10032
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Staten Island、New York、アメリカ、10312
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North Carolina
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Raleigh、North Carolina、アメリカ、27607
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Winston-Salem、North Carolina、アメリカ、27103
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Ohio
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Beachwood、Ohio、アメリカ、44122
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Toledo、Ohio、アメリカ、43623
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ、73116
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Oregon
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Eugene、Oregon、アメリカ、97401
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Portland、Oregon、アメリカ、97210
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
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Rhode Island
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East Providence、Rhode Island、アメリカ、02914
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South Carolina
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Charleston、South Carolina、アメリカ、29425
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Greer、South Carolina、アメリカ、29650
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South Dakota
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Sioux Falls、South Dakota、アメリカ、57105
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Utah
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Salt Lake City、Utah、アメリカ、84108
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Vermont
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Bennington、Vermont、アメリカ、05201
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Burlington、Vermont、アメリカ、05401
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Virginia
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Norfolk、Virginia、アメリカ、23502
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Roanoke、Virginia、アメリカ、24018
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Washington
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Seattle、Washington、アメリカ、98108
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Buenos Aires、アルゼンチン、CBA 1419
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Ciudad Automona De Buenos Aire、アルゼンチン、C1111AAL
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Cordoba、アルゼンチン、X5004AOA
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Mendoza、アルゼンチン、5500
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Rosario、アルゼンチン、S2000BZL
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Santa Fe、アルゼンチン、S3000FWO
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E Susx
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Uckfield、E Susx、イギリス、TN225AW
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Glasgow
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Scotland、Glasgow、イギリス、G20 0XA
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Greater London
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London、Greater London、イギリス、N195NX
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London
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Camberwell、London、イギリス、SE5 8AF
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Baggiovara、イタリア、41100
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Biella、イタリア、13900
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Chieti、イタリア、66013
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Genova、イタリア、16128
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Lido Di Camaiore、イタリア、55043
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Milano、イタリア、20132
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Rome、イタリア、00186
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New South Wales
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Gosford、New South Wales、オーストラリア、2250
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Kogarah、New South Wales、オーストラリア、2217
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Queensland
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Chermside、Queensland、オーストラリア、4032
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Toowoomba、Queensland、オーストラリア、4650
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Victoria
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Box Hill、Victoria、オーストラリア、3128
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Glen Iris、Victoria、オーストラリア、3146
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Heidelberg Heights、Victoria、オーストラリア、3081
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Melbourne、Victoria、オーストラリア、3004
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Western Australia
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Subiaco、Western Australia、オーストラリア、6008
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Alberta
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Medicine Hat、Alberta、カナダ、T1B4E7
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British Columbia
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Kelowna、British Columbia、カナダ、V1Y3G5
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Penticton、British Columbia、カナダ、V2A 5C8
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Ontario
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Ottawa、Ontario、カナダ、K1N 5C8
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Toronto、Ontario、カナダ、M6M 3Z5
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Quebec
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Greenfield Park、Quebec、カナダ、J4V 2J2
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Sherbrooke、Quebec、カナダ、J1H1Z1
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Jönköping、スウェーデン、551 85
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Kalmar、スウェーデン、39185
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Lund、スウェーデン、22241
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Molndal、スウェーデン、43135
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Umea、スウェーデン、901 85
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Barcelona、スペイン、08014
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Getafe、スペイン、28905
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Madrid、スペイン、28006
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Plasencia、スペイン、10600
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Terrassa、スペイン、08221
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Berlin、ドイツ、12203
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Hamburg、ドイツ、22307
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Hannover、ドイツ、30559
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Mannheim、ドイツ、68165
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Munich、ドイツ、D-81675
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Regensburg、ドイツ、93042
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Paris、フランス、75475
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Rennes、フランス、35000
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Strasbourg、フランス、67091
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Toulouse、フランス、31300
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Curitiba、ブラジル、80060-900
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Itapira、ブラジル、13970-905
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Porto Alegre、ブラジル、90110-270
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Rio De Janeiro、ブラジル、22271-100
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São Paulo、ブラジル、04024-002
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Bydgoszcz、ポーランド、85-796
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Gliwice、ポーランド、44-100
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Katowice、ポーランド、40-588
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Krakow、ポーランド、31-530
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Lublin、ポーランド、20-954
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Warsaw、ポーランド、01-211
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Chelyabinsk、ロシア連邦、454091
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Saint Petersburg、ロシア連邦、190021
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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、大韓民国、400-711
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Seongnam-Si、大韓民国、463-707
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Seoul、大韓民国、143-729
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Suwon-Si、大韓民国、443-721
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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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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
55年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：プラセボ
|
Participants were from feeder studies (LZAM or LZAN).
Placebo administered intravenously every 4 weeks through Week 80.
|
|
実験的：Solanezumab
|
400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Assess the Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive 14-Item Scale (ADAS-Cog14)
時間枠：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
|
|
Change From Baseline to 104-week Endpoint in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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.
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Baseline, Week 104
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Change From Baseline to 104-week Endpoint in Mini-Mental State Examination (MMSE)
時間枠：Baseline, Week 104
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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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2010年12月1日
一次修了 (実際)
2014年7月1日
研究の完了 (実際)
2017年2月1日
試験登録日
最初に提出
2010年5月19日
QC基準を満たした最初の提出物
2010年5月19日
最初の投稿 (見積もり)
2010年5月21日
学習記録の更新
投稿された最後の更新 (実際)
2019年10月8日
QC基準を満たした最後の更新が送信されました
2019年9月25日
最終確認日
2019年9月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 11935 (レジストリ識別子：DAIDS ES Registry Number)
- H8A-MC-LZAO (その他の識別子：Eli Lilly and Company)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
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 共有アクセス基準
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- CSR
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。