Effect of LY2062430 on the Progression of Alzheimer's Disease (EXPEDITION)
2012年9月18日 更新者：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.
研究概览
研究类型
介入性
注册 (预期的)
1000
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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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、V1Y3G8
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Penticton、British Columbia、加拿大、V2A5C8
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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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Curitiba、巴西、81210-310
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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、20941-150
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São Paulo、巴西、04024-002
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Aichi、日本、474-8511
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Fukuoka、日本、812-0033
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Hiroshima、日本、720-0825
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Kanagawa、日本、243-8550
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Kyoto、日本、607-8062
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Osaka、日本、567
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Shizuoka、日本、420-8688
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Tokyo、日本、187-8551
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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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Tuscon、Arizona、美国、85718
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Arkansas
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Little Rock、Arkansas、美国、72205
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California
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Carson、California、美国、90746
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Irvine、California、美国、92697
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Laguna Hills、California、美国、92653
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Lomita、California、美国、90717
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Orange、California、美国、92868
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Oxnard、California、美国、93030
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Santa Ana、California、美国、92705
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Colorado
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Denver、Colorado、美国、80239
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Connecticut
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Fairfield、Connecticut、美国、06824
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Hamden、Connecticut、美国、06518
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New Haven、Connecticut、美国、06510
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Norwalk、Connecticut、美国、06851
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Delaware
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Newark、Delaware、美国、19713
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District of Columbia
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Washington、District of Columbia、美国、20007
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Florida
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Boca Raton、Florida、美国、33431
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Fort Myers、Florida、美国、33912
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Hollywood、Florida、美国、33021
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Miami Springs、Florida、美国、33166
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North Miami、Florida、美国、33161
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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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Grand Rapids、Michigan、美国、49525
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Traverse City、Michigan、美国、49684
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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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Bronx、New York、美国、10454
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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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Orangeburg、New York、美国、10962
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North Carolina
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Raleigh、North Carolina、美国、27607
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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
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Toledo、Ohio、美国、43623
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Oklahoma
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Oklahoma City、Oklahoma、美国、73116
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Oregon
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Eugene、Oregon、美国、97401
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
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Rhode Island
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East Providence、Rhode Island、美国、02914
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South Carolina
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Charleston、South Carolina、美国、29425
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Greer、South Carolina、美国、29651
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South Dakota
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Sioux Falls、South Dakota、美国、57105
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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
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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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Buenos Aires、阿根廷、CBA 1419
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Cordoba、阿根廷、X5004AOA
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Mendoza、阿根廷、5500
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Pueyrredon Cordoba、阿根廷、X5005ALB
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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 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
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：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：安慰剂
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静脉内 (IV) 每 4 周一次，持续 80 周
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实验性的：LY2062430
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400 毫克静脉注射 (IV) 每 4 周一次，持续 80 周
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Change from baseline to endpoint in Alzheimer's Disease Assessment Scale-Cognitive subscore (ADAS-Cog11)
大体时间：Baseline, 80 weeks
|
Baseline, 80 weeks
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Change from baseline to endpoint in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL)
大体时间：Baseline, 80 weeks
|
Baseline, 80 weeks
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Change from baseline to endpoint in Clinical Dementia Rating-Sum of Boxes (CDR-SB)
大体时间：Baseline, 80 weeks
|
Baseline, 80 weeks
|
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Change from baseline to endpoint in Neuropsychiatric Inventory (NPI)
大体时间：Baseline, 80 weeks
|
Baseline, 80 weeks
|
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Change from baseline to endpoint in volumetric magnetic resonance imaging (vMRI)
大体时间：Baseline, 80 weeks
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Baseline, 80 weeks
|
|
Change from baseline to endpoint in Mini-Mental State Examination (MMSE)
大体时间：Baseline, 80 weeks
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Baseline, 80 weeks
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Change from baseline to endpoint in Resource Utilization in Dementia-Lite (RUD-Lite)
大体时间：Baseline, 80 weeks
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Baseline, 80 weeks
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Change from baseline to endpoint in EuroQol 5-Dimensional Health-related Quality of Life Scale Proxy version (EQ-5D Proxy)
大体时间：Baseline, 80 weeks
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Baseline, 80 weeks
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Change from baseline to endpoint in Quality of Life in Alzheimer's Disease (QoL-AD)
大体时间：Baseline, 80 weeks
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Baseline, 80 weeks
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Change from baseline to endpoint in plasma LY2062430 to investigate a relationship between plasma LY2062430 and plasma A Beta levels.
大体时间：Baseline, 80 weeks
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Baseline, 80 weeks
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Change from baseline to endpoint in plasma A Beta
大体时间：Baseline, 80 weeks
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Baseline, 80 weeks
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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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
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
2009年5月1日
初级完成 (实际的)
2012年4月1日
研究完成 (实际的)
2012年4月1日
研究注册日期
首次提交
2009年5月18日
首先提交符合 QC 标准的
2009年5月18日
首次发布 (估计)
2009年5月20日
研究记录更新
最后更新发布 (估计)
2012年9月25日
上次提交的符合 QC 标准的更新
2012年9月18日
最后验证
2012年5月1日
更多信息
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.
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