Continued Safety Monitoring of Solanezumab (LY2062430) in Alzheimer's Disease (EXPEDITION EXT)
2019년 9월 25일 업데이트: 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).
연구 개요
연구 유형
중재적
등록 (실제)
1457
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Guishan, 대만, 33305
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Niaosong, 대만, 833
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Taipei, 대만, 112
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Incheon, 대한민국, 400-711
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Seongnam-Si, 대한민국, 463-707
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Seoul, 대한민국, 143-729
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Suwon-Si, 대한민국, 443-721
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Berlin, 독일, 12203
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Hamburg, 독일, 22307
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Hannover, 독일, 30559
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Mannheim, 독일, 68165
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Munich, 독일, D-81675
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Regensburg, 독일, 93042
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Chelyabinsk, 러시아 연방, 454091
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Saint Petersburg, 러시아 연방, 190021
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Arizona
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Phoenix, Arizona, 미국, 85006
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Sun City, Arizona, 미국, 85351
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Tucson, Arizona, 미국, 85718
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Arkansas
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Little Rock, Arkansas, 미국, 72211
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California
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Carson, California, 미국, 90746
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Laguna Hills, California, 미국, 92653
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Lomita, California, 미국, 90717
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Los Angeles, California, 미국, 90073
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Oxnard, California, 미국, 93030
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San Diego, California, 미국, 92103
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San Francisco, California, 미국, 94109
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Santa Ana, California, 미국, 92705
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Santa Monica, California, 미국, 90404
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Colorado
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Denver, Colorado, 미국, 80239
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Connecticut
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Fairfield, Connecticut, 미국, 06824
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Hamden, Connecticut, 미국, 06518
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New Haven, Connecticut, 미국, 06510
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Norwalk, Connecticut, 미국, 06851
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Delaware
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Newark, Delaware, 미국, 19713
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District of Columbia
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Washington, District of Columbia, 미국, 20057
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Florida
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Boca Raton, Florida, 미국, 33431
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Fort Myers, Florida, 미국, 33912
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Hollywood, Florida, 미국, 33021
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Miami, Florida, 미국, 33137
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Miami Springs, Florida, 미국, 33166
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Orange City, Florida, 미국, 32763
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Orlando, Florida, 미국, 32806
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Sunrise, Florida, 미국, 33351
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Tampa, Florida, 미국, 33613
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Georgia
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Atlanta, Georgia, 미국, 30341
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Canton, Georgia, 미국, 30114
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Decatur, Georgia, 미국, 30033
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Indiana
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Indianapolis, Indiana, 미국, 46202
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Kentucky
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Lexington, Kentucky, 미국, 40503
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Maryland
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Baltimore, Maryland, 미국, 21285
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Rockville, Maryland, 미국, 20852
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Massachusetts
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Belmont, Massachusetts, 미국, 02478
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Michigan
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Traverse City, Michigan, 미국, 49684
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Missouri
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Creve Coeur, Missouri, 미국, 63141
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New Mexico
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Albuquerque, New Mexico, 미국, 87109
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New York
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Albany, New York, 미국, 12205
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Amherst, New York, 미국, 14226
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Brooklyn, New York, 미국, 11235
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Latham, New York, 미국, 12210
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New York, New York, 미국, 10032
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Staten Island, New York, 미국, 10312
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North Carolina
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Raleigh, North Carolina, 미국, 27607
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Winston-Salem, North Carolina, 미국, 27103
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Ohio
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Beachwood, Ohio, 미국, 44122
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Toledo, Ohio, 미국, 43623
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73116
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Oregon
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Eugene, Oregon, 미국, 97401
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Portland, Oregon, 미국, 97210
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
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Rhode Island
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East Providence, Rhode Island, 미국, 02914
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South Carolina
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Charleston, South Carolina, 미국, 29425
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Greer, South Carolina, 미국, 29650
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South Dakota
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Sioux Falls, South Dakota, 미국, 57105
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Utah
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Salt Lake City, Utah, 미국, 84108
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Vermont
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Bennington, Vermont, 미국, 05201
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Burlington, Vermont, 미국, 05401
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Virginia
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Norfolk, Virginia, 미국, 23502
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Roanoke, Virginia, 미국, 24018
- 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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Washington
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Seattle, Washington, 미국, 98108
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Curitiba, 브라질, 80060-900
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Itapira, 브라질, 13970-905
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Porto Alegre, 브라질, 90110-270
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Rio De Janeiro, 브라질, 22271-100
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São Paulo, 브라질, 04024-002
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Jönköping, 스웨덴, 551 85
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Kalmar, 스웨덴, 39185
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Lund, 스웨덴, 22241
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Molndal, 스웨덴, 43135
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Umea, 스웨덴, 901 85
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Barcelona, 스페인, 08014
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Getafe, 스페인, 28905
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Madrid, 스페인, 28006
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Plasencia, 스페인, 10600
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Terrassa, 스페인, 08221
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Buenos Aires, 아르헨티나, CBA 1419
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Ciudad Automona De Buenos Aire, 아르헨티나, C1111AAL
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Cordoba, 아르헨티나, X5004AOA
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Mendoza, 아르헨티나, 5500
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Rosario, 아르헨티나, S2000BZL
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Santa Fe, 아르헨티나, S3000FWO
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E Susx
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Uckfield, E Susx, 영국, TN225AW
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Glasgow
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Scotland, Glasgow, 영국, G20 0XA
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Greater London
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London, Greater London, 영국, N195NX
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London
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Camberwell, London, 영국, SE5 8AF
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Baggiovara, 이탈리아, 41100
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Biella, 이탈리아, 13900
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Chieti, 이탈리아, 66013
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Genova, 이탈리아, 16128
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Lido Di Camaiore, 이탈리아, 55043
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Milano, 이탈리아, 20132
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Rome, 이탈리아, 00186
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Aichi, 일본, 474-8511
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Ehime, 일본, 791-0295
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Fukuoka, 일본, 816-0864
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Hiroshima, 일본, 720-0825
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Hyogo, 일본, 514-8507
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Kanagawa, 일본, 247-8533
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Kyoto, 일본, 607-8062
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Osaka, 일본, 545-8586
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Shizuoka, 일본, 424-0911
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Tokyo, 일본, 187-8551
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Alberta
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Medicine Hat, Alberta, 캐나다, T1B4E7
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British Columbia
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Kelowna, British Columbia, 캐나다, V1Y3G5
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Penticton, British Columbia, 캐나다, V2A 5C8
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Ontario
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Ottawa, Ontario, 캐나다, K1N 5C8
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Toronto, Ontario, 캐나다, M6M 3Z5
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Quebec
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Greenfield Park, Quebec, 캐나다, J4V 2J2
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Sherbrooke, Quebec, 캐나다, J1H1Z1
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Bydgoszcz, 폴란드, 85-796
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Gliwice, 폴란드, 44-100
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Katowice, 폴란드, 40-588
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Krakow, 폴란드, 31-530
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Lublin, 폴란드, 20-954
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Warsaw, 폴란드, 01-211
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Paris, 프랑스, 75475
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Rennes, 프랑스, 35000
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Strasbourg, 프랑스, 67091
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Toulouse, 프랑스, 31300
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New South Wales
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Gosford, New South Wales, 호주, 2250
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Kogarah, New South Wales, 호주, 2217
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Queensland
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Chermside, Queensland, 호주, 4032
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Toowoomba, Queensland, 호주, 4650
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Victoria
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Box Hill, Victoria, 호주, 3128
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Glen Iris, Victoria, 호주, 3146
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Heidelberg Heights, Victoria, 호주, 3081
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Melbourne, Victoria, 호주, 3004
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Western Australia
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Subiaco, Western Australia, 호주, 6008
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-
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
55년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
위약 비교기: 위약
|
Participants were from feeder studies (LZAM or LZAN).
Placebo administered intravenously every 4 weeks through Week 80.
|
|
실험적: Solanezumab
|
400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Assess the Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs)
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive 14-Item Scale (ADAS-Cog14)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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.
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Baseline, Week 104
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Change From Baseline to 104-week Endpoint in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy)
기간: Baseline, Week 104
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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.
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Baseline, Week 104
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Change From Baseline to 104-week Endpoint in Quality of Life in Alzheimer's Disease (QoL-AD)
기간: Baseline, Week 104
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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)
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2010년 12월 1일
기본 완료 (실제)
2014년 7월 1일
연구 완료 (실제)
2017년 2월 1일
연구 등록 날짜
최초 제출
2010년 5월 19일
QC 기준을 충족하는 최초 제출
2010년 5월 19일
처음 게시됨 (추정)
2010년 5월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 10월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 9월 25일
마지막으로 확인됨
2019년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 11935 (레지스트리 식별자: DAIDS ES Registry Number)
- H8A-MC-LZAO (기타 식별자: Eli Lilly and Company)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
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 공유 액세스 기준
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- CSR
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Solanezumab에 대한 임상 시험
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Eli Lilly and Company완전한알츠하이머병미국, 아르헨티나, 브라질, 일본, 캐나다
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Eli Lilly and Company완전한알츠하이머병스페인, 미국, 프랑스, 대한민국, 일본, 호주, 대만, 스웨덴, 독일, 이탈리아, 폴란드, 러시아 연방, 영국
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Washington University School of MedicineEli Lilly and Company; Hoffmann-La Roche; Avid Radiopharmaceuticals; National Institute on... 그리고 다른 협력자들완전한백치 | 알츠하이머병 | 알츠하이머병, 가족미국, 캐나다, 프랑스, 스페인, 아일랜드, 호주, 푸에르토 리코, 영국
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Washington University School of MedicineEli Lilly and Company; Hoffmann-La Roche; Avid Radiopharmaceuticals; National Institute on... 그리고 다른 협력자들모병백치 | 알츠하이머병 | 알츠하이머병, 가족미국, 캐나다, 이탈리아, 아르헨티나, 호주, 콜롬비아, 프랑스, 아일랜드, 멕시코, 네덜란드, 푸에르토 리코, 스페인, 영국, 브라질, 일본, 독일