Effect of LY2062430 on the Progression of Alzheimer's Disease (EXPEDITION)
18 сентября 2012 г. обновлено: Eli Lilly and Company
Effect of LY2062430, an Anti-Amyloid Beta Monoclonal Antibody, on the Progression of Alzheimer's Disease as Compared With Placebo
Alzheimer's disease (AD) is an age-related degenerative disorder of the brain, characterized by progressive decline in cognitive function and ability to perform activities of daily living, and ultimately can lead to death due to complications of the disease. AD is thought to be caused by an excess of A-Beta amyloid, a sticky protein in the brain that forms amyloid plaques. Treatments that slow the synthesis or deposition of A-Beta amyloid, or that increase clearance, might be expected to slow the progression of AD.
LY2062430 (solanezumab) is a humanized anti-A Beta peptide immunoglobulin G-1 (IgG1) monoclonal antibody being developed for the treatment of AD. The primary hypothesis being tested is that LY2062430 will slow cognitive and functional decline in AD as compared with placebo. Each patient's participation will last approximately 19 months. Patients taking approved AD medications may participate in this study and continue taking these medications during the study.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Ожидаемый)
1000
Фаза
- Фаза 3
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Buenos Aires, Аргентина, CBA 1419
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Cordoba, Аргентина, X5004AOA
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Mendoza, Аргентина, 5500
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Pueyrredon Cordoba, Аргентина, X5005ALB
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Rosario, Аргентина, S2000BZL
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Santa Fe, Аргентина, S3000FWO
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Curitiba, Бразилия, 81210-310
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Itapira, Бразилия, 13970-905
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Porto Alegre, Бразилия, 90110-270
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Rio De Janeiro, Бразилия, 20941-150
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São Paulo, Бразилия, 04024-002
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Alberta
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Medicine Hat, Alberta, Канада, T1B4E7
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British Columbia
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Kelowna, British Columbia, Канада, V1Y3G8
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Penticton, British Columbia, Канада, V2A5C8
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Ontario
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Ottawa, Ontario, Канада, K1N 5C8
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Toronto, Ontario, Канада, M6M 3Z5
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Quebec
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Greenfield Park, Quebec, Канада, J4V 2J2
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Sherbrooke, Quebec, Канада, J1H1Z1
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Arizona
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Phoenix, Arizona, Соединенные Штаты, 85006
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Sun City, Arizona, Соединенные Штаты, 85351
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Tuscon, Arizona, Соединенные Штаты, 85718
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Arkansas
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Little Rock, Arkansas, Соединенные Штаты, 72205
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California
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Carson, California, Соединенные Штаты, 90746
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Irvine, California, Соединенные Штаты, 92697
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Laguna Hills, California, Соединенные Штаты, 92653
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Lomita, California, Соединенные Штаты, 90717
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Orange, California, Соединенные Штаты, 92868
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Oxnard, California, Соединенные Штаты, 93030
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Santa Ana, California, Соединенные Штаты, 92705
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Colorado
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Denver, Colorado, Соединенные Штаты, 80239
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Connecticut
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Fairfield, Connecticut, Соединенные Штаты, 06824
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Hamden, Connecticut, Соединенные Штаты, 06518
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New Haven, Connecticut, Соединенные Штаты, 06510
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Norwalk, Connecticut, Соединенные Штаты, 06851
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Delaware
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Newark, Delaware, Соединенные Штаты, 19713
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District of Columbia
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Washington, District of Columbia, Соединенные Штаты, 20007
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Florida
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Boca Raton, Florida, Соединенные Штаты, 33431
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Fort Myers, Florida, Соединенные Штаты, 33912
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Hollywood, Florida, Соединенные Штаты, 33021
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Miami Springs, Florida, Соединенные Штаты, 33166
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North Miami, Florida, Соединенные Штаты, 33161
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Orange City, Florida, Соединенные Штаты, 32763
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Orlando, Florida, Соединенные Штаты, 32806
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Sunrise, Florida, Соединенные Штаты, 33351
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Tampa, Florida, Соединенные Штаты, 33613
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Georgia
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Atlanta, Georgia, Соединенные Штаты, 30341
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Canton, Georgia, Соединенные Штаты, 30114
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Decatur, Georgia, Соединенные Штаты, 30033
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Indiana
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Indianapolis, Indiana, Соединенные Штаты, 46202
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Kentucky
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Lexington, Kentucky, Соединенные Штаты, 40503
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Maryland
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Baltimore, Maryland, Соединенные Штаты, 21285
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Rockville, Maryland, Соединенные Штаты, 20852
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Massachusetts
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Belmont, Massachusetts, Соединенные Штаты, 02478
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Michigan
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Grand Rapids, Michigan, Соединенные Штаты, 49525
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Traverse City, Michigan, Соединенные Штаты, 49684
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New Mexico
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Albuquerque, New Mexico, Соединенные Штаты, 87109
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New York
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Albany, New York, Соединенные Штаты, 12205
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Bronx, New York, Соединенные Штаты, 10454
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Latham, New York, Соединенные Штаты, 12210
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New York, New York, Соединенные Штаты, 10032
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Orangeburg, New York, Соединенные Штаты, 10962
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North Carolina
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Raleigh, North Carolina, Соединенные Штаты, 27607
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Winston-Salem, North Carolina, Соединенные Штаты, 27103
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Ohio
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Beachwood, Ohio, Соединенные Штаты, 44122
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Toledo, Ohio, Соединенные Штаты, 43623
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Oklahoma
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Oklahoma City, Oklahoma, Соединенные Штаты, 73116
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Oregon
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Eugene, Oregon, Соединенные Штаты, 97401
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Pennsylvania
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Philadelphia, Pennsylvania, Соединенные Штаты, 19104
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Rhode Island
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East Providence, Rhode Island, Соединенные Штаты, 02914
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South Carolina
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Charleston, South Carolina, Соединенные Штаты, 29425
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Greer, South Carolina, Соединенные Штаты, 29651
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South Dakota
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Sioux Falls, South Dakota, Соединенные Штаты, 57105
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Utah
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Salt Lake City, Utah, Соединенные Штаты, 84108
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Vermont
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Bennington, Vermont, Соединенные Штаты, 05201
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Burlington, Vermont, Соединенные Штаты, 05401
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Virginia
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Norfolk, Virginia, Соединенные Штаты, 23502
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Roanoke, Virginia, Соединенные Штаты, 24018
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Aichi, Япония, 474-8511
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Fukuoka, Япония, 812-0033
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Hiroshima, Япония, 720-0825
- 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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Kanagawa, Япония, 243-8550
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kyoto, Япония, 607-8062
- 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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Osaka, Япония, 567
- 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.
-
Shizuoka, Япония, 420-8688
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tokyo, Япония, 187-8551
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
55 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- Meets criteria for mild to moderate Alzheimer's Disease (AD) with Mini-Mental State Examination score of 16 through 26 at screening
- Modified Hachinski Ischemia Scale score of less than or equal to 4
- Geriatric Depression Scale score of less than or equal to 6
- A magnetic resonance imaging (MRI) or computerized tomography (CT) scan in the last 2 years with no findings inconsistent with a diagnosis of AD
- If receiving concurrent AD treatment, must be on the medication for at least 4 months at a stable dose for at least 2 months prior to randomization
Exclusion Criteria:
- Has serious or unstable illness(es)
- Does not have a reliable caregiver who is in frequent contact with patient (at least 10 hours per week)
- Meets National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia
- Does not have good venous access, such that intravenous (IV) drug delivery would be difficult
- Has had multiple episodes of head trauma or history within the last 5 years of a serious infectious disease affecting the brain
- Has allergies to humanized monoclonal antibodies
- Chronic alcohol and/or drug abuse within the past 5 years
- Has any contraindications for MRI studies
- Requires treatment with another monoclonal antibody
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Плацебо Компаратор: Плацебо
|
внутривенно (в/в) каждые 4 недели в течение 80 недель
|
|
Экспериментальный: LY2062430
|
400 мг внутривенно (в/в) каждые 4 недели в течение 80 недель
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Change from baseline to endpoint in Alzheimer's Disease Assessment Scale-Cognitive subscore (ADAS-Cog11)
Временное ограничение: Baseline, 80 weeks
|
Baseline, 80 weeks
|
|
Change from baseline to endpoint in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL)
Временное ограничение: Baseline, 80 weeks
|
Baseline, 80 weeks
|
Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Change from baseline to endpoint in Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Временное ограничение: Baseline, 80 weeks
|
Baseline, 80 weeks
|
|
Change from baseline to endpoint in Neuropsychiatric Inventory (NPI)
Временное ограничение: Baseline, 80 weeks
|
Baseline, 80 weeks
|
|
Change from baseline to endpoint in volumetric magnetic resonance imaging (vMRI)
Временное ограничение: Baseline, 80 weeks
|
Baseline, 80 weeks
|
|
Change from baseline to endpoint in Mini-Mental State Examination (MMSE)
Временное ограничение: Baseline, 80 weeks
|
Baseline, 80 weeks
|
|
Change from baseline to endpoint in Resource Utilization in Dementia-Lite (RUD-Lite)
Временное ограничение: Baseline, 80 weeks
|
Baseline, 80 weeks
|
|
Change from baseline to endpoint in EuroQol 5-Dimensional Health-related Quality of Life Scale Proxy version (EQ-5D Proxy)
Временное ограничение: Baseline, 80 weeks
|
Baseline, 80 weeks
|
|
Change from baseline to endpoint in Quality of Life in Alzheimer's Disease (QoL-AD)
Временное ограничение: Baseline, 80 weeks
|
Baseline, 80 weeks
|
|
Change from baseline to endpoint in plasma LY2062430 to investigate a relationship between plasma LY2062430 and plasma A Beta levels.
Временное ограничение: Baseline, 80 weeks
|
Baseline, 80 weeks
|
|
Change from baseline to endpoint in plasma A Beta
Временное ограничение: Baseline, 80 weeks
|
Baseline, 80 weeks
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- Reed C, Belger M, Dell'Agnello G, Kahle-Wrobleski K, Sethuraman G, Hake A, Raskin J, Henley D. Representativeness of European clinical trial populations in mild Alzheimer's disease dementia: a comparison of 18-month outcomes with real-world data from the GERAS observational study. Alzheimers Res Ther. 2018 Apr 3;10(1):36. doi: 10.1186/s13195-018-0360-4.
- Liu-Seifert H, Siemers E, Price K, Han B, Selzler KJ, Henley D, Sundell K, Aisen P, Cummings J, Raskin J, Mohs R; Alzheimer's Disease Neuroimaging Initiative. Cognitive Impairment Precedes and Predicts Functional Impairment in Mild Alzheimer's Disease. J Alzheimers Dis. 2015;47(1):205-14. doi: 10.3233/JAD-142508.
- Henley DB, Dowsett SA, Chen YF, Liu-Seifert H, Grill JD, Doody RS, Aisen P, Raman R, Miller DS, Hake AM, Cummings J. Alzheimer's disease progression by geographical region in a clinical trial setting. Alzheimers Res Ther. 2015 Jun 25;7(1):43. doi: 10.1186/s13195-015-0127-0. eCollection 2015.
- Liu-Seifert H, Siemers E, Sundell K, Price K, Han B, Selzler K, Aisen P, Cummings J, Raskin J, Mohs R. Cognitive and functional decline and their relationship in patients with mild Alzheimer's dementia. J Alzheimers Dis. 2015;43(3):949-55. doi: 10.3233/JAD-140792.
- Doody RS, Thomas RG, Farlow M, Iwatsubo T, Vellas B, Joffe S, Kieburtz K, Raman R, Sun X, Aisen PS, Siemers E, Liu-Seifert H, Mohs R; Alzheimer's Disease Cooperative Study Steering Committee; Solanezumab Study Group. Phase 3 trials of solanezumab for mild-to-moderate Alzheimer's disease. N Engl J Med. 2014 Jan 23;370(4):311-21. doi: 10.1056/NEJMoa1312889.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 мая 2009 г.
Первичное завершение (Действительный)
1 апреля 2012 г.
Завершение исследования (Действительный)
1 апреля 2012 г.
Даты регистрации исследования
Первый отправленный
18 мая 2009 г.
Впервые представлено, что соответствует критериям контроля качества
18 мая 2009 г.
Первый опубликованный (Оценивать)
20 мая 2009 г.
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
25 сентября 2012 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
18 сентября 2012 г.
Последняя проверка
1 мая 2012 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 6747
- H8A-MC-LZAM (Другой идентификатор: Eli Lilly and Company)
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .