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.
調査の概要
研究の種類
介入
入学 (予想される)
1000
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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Tuscon、Arizona、アメリカ、85718
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Arkansas
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Little Rock、Arkansas、アメリカ、72205
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California
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Carson、California、アメリカ、90746
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Irvine、California、アメリカ、92697
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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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Orange、California、アメリカ、92868
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Oxnard、California、アメリカ、93030
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Santa Ana、California、アメリカ、92705
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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、20007
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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 Springs、Florida、アメリカ、33166
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North Miami、Florida、アメリカ、33161
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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
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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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Grand Rapids、Michigan、アメリカ、49525
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Traverse City、Michigan、アメリカ、49684
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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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Bronx、New York、アメリカ、10454
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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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Orangeburg、New York、アメリカ、10962
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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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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、29651
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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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Buenos Aires、アルゼンチン、CBA 1419
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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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Pueyrredon Cordoba、アルゼンチン、X5005ALB
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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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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、V1Y3G8
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Penticton、British Columbia、カナダ、V2A5C8
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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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Curitiba、ブラジル、81210-310
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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、20941-150
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São Paulo、ブラジル、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
- 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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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 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
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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：プラセボ
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80週間にわたって4週間ごとに静脈内（IV）投与
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実験的：LY2062430
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80週間にわたって4週間ごとに400 mgを静脈内（IV）投与
他の名前：
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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 |
時間枠 |
|---|---|
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Change from baseline to endpoint in Alzheimer's Disease Assessment Scale-Cognitive subscore (ADAS-Cog11)
時間枠：Baseline, 80 weeks
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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)
時間枠：Baseline, 80 weeks
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Baseline, 80 weeks
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Change from baseline to endpoint in Clinical Dementia Rating-Sum of Boxes (CDR-SB)
時間枠：Baseline, 80 weeks
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Baseline, 80 weeks
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Change from baseline to endpoint in Neuropsychiatric Inventory (NPI)
時間枠：Baseline, 80 weeks
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Baseline, 80 weeks
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Change from baseline to endpoint in volumetric magnetic resonance imaging (vMRI)
時間枠：Baseline, 80 weeks
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Baseline, 80 weeks
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Change from baseline to endpoint in Mini-Mental State Examination (MMSE)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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.
時間枠：Baseline, 80 weeks
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Baseline, 80 weeks
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Change from baseline to endpoint in plasma A Beta
時間枠：Baseline, 80 weeks
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Baseline, 80 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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
2009年5月1日
一次修了 (実際)
2012年4月1日
研究の完了 (実際)
2012年4月1日
試験登録日
最初に提出
2009年5月18日
QC基準を満たした最初の提出物
2009年5月18日
最初の投稿 (見積もり)
2009年5月20日
学習記録の更新
投稿された最後の更新 (見積もり)
2012年9月25日
QC基準を満たした最後の更新が送信されました
2012年9月18日
最終確認日
2012年5月1日
詳しくは
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。
アルツハイマー病の臨床試験
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HuidaGene Therapeutics Co., Ltd.募集
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Hemab ApSPSI CRO募集フォン・ヴィレブランド病（VWD） | フォン・ヴィレブランド病 (VWD)、タイプ 1 | フォンウィルブランド病（VWD）、タイプ2 | Von Willebrand Disease（VWD）、タイプ3 | フォン・ウィルブランド病、タイプ2a | Von Willebrand病、タイプ2M | Von Willebrand病、タイプ2Nアメリカ, イギリス, オーストラリア
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Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ
LY2062430の臨床試験
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Eli Lilly and Company終了しました
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Eli Lilly and CompanyAlzheimer's Therapeutic Research Institute完了
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Eli Lilly and Company終了しましたアルツハイマー病アメリカ, アルゼンチン, フランス, 日本, カナダ, 大韓民国, オーストラリア, ブラジル, スペイン, 台湾, イタリア, ポーランド, ドイツ, ロシア連邦, イギリス, スウェーデン
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Eli Lilly and Company終了しましたアルツハイマー病イタリア, アメリカ, スペイン, 台湾, フランス, 日本, プエルトリコ, ポーランド, スウェーデン, フィンランド, カナダ, イギリス, ドイツ
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Eli Lilly and Company終了しましたアルツハイマー病アメリカ, イタリア, フランス, 日本, オーストラリア, ドイツ, スペイン, スウェーデン, カナダ, ポーランド, イギリス
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Eli Lilly and Company完了アルツハイマー病スペイン, アメリカ, フランス, 大韓民国, 日本, オーストラリア, 台湾, スウェーデン, ドイツ, イタリア, ポーランド, ロシア連邦, イギリス
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Washington University School of MedicineEli Lilly and Company; Hoffmann-La Roche; Avid Radiopharmaceuticals; National Institute on Aging... と他の協力者完了認知症 | アルツハイマー病 | アルツハイマー病、家族性アメリカ, カナダ, フランス, スペイン, アイルランド, オーストラリア, プエルトリコ, イギリス