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A Long-Term Safety and Tolerability Study in Subjects With Mild to Moderate Alzheimer's Disease

2013年11月26日 更新者：JANSSEN Alzheimer Immunotherapy Research & Development, LLC

A Phase 3 Extension, Multicenter, Double-Blind, Long-Term Safety and Tolerability Treatment Trial of Bapineuzumab (AAB-001, ELN115727) in Subjects With Alzheimer's Disease Who Participated in Study ELN115727-301 or Study ELN115727-302.

The purpose of this study is to assess the long-term safety and tolerability of Bapineuzumab (AAB-001, ELN115727) in subjects with Alzheimer's disease who participated in study ELN115727-301 or study ELN115727-302.

研究概览

地位

终止

条件

干预/治疗

研究类型

介入性

注册 (实际的)

896

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

  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T2N 4Z6
        • University of Calgary, Foothills Medical Centre
    • British Columbia
      • Kamloops、British Columbia、加拿大、V2C 1K7
        • Medical Arts Health Research Group
      • Kelowna、British Columbia、加拿大、V1Y 3G8
        • Medical Arts Health Research Group
    • Ontario
      • Kingston、Ontario、加拿大、K7L 5G2
        • Queens University Memorial Clinics
      • London、Ontario、加拿大、N6C 5J1
        • Parkwood Hospital
      • Ottawa、Ontario、加拿大、K1N 5C8
        • Bruyere Continuing Care
      • Toronto、Ontario、加拿大、M3B 2S7
        • Neurology Research Inc
      • Toronto、Ontario、加拿大、M6M 3Z5
        • Toronto Centre for Memory and Aging
      • Whitby、Ontario、加拿大、L1N 5S9
        • Ontario Shores Centre For Mental Health Sciences
    • Quebec
      • Greenfield Park、Quebec、加拿大、J4V 2J2
        • Neuro Rive-Sud Memory Clinic
      • Montréal、Quebec、加拿大、H1T 2M4
        • Hopital Maisonneuve-Rosemont
      • Montréal、Quebec、加拿大、H3T 1E2
        • Sir Mortimer B. Davis, Jewish General Hospital
      • Sherbrooke、Quebec、加拿大、J1H 1Z1
        • Diex Research Sherbrooke Inc.
      • Verdun、Quebec、加拿大、H4H 1R3
        • Douglas Mental Health University Institute
  • 奥地利
    • Styria
      • Graz、Styria、奥地利、8036
        • Landeskrankenhaus- Universitätsklinikum Graz
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35205
        • University of Alabama Hospital
    • Arizona
      • Goodyear、Arizona、美国、85395
        • Dedicated Clinical Research, Inc.
      • Phoenix、Arizona、美国、85006
        • Banner Alzheimer's Institute
      • Phoenix、Arizona、美国、85050
        • HOPE Research Institute, LLC
      • Sun City、Arizona、美国、85351
        • Banner Research Institute
      • Tucson、Arizona、美国、85724
        • University of Arizona College of Medicine, Health Sciences Center
      • Tucson、Arizona、美国、85741
        • Northwest NeuroSpecialists, PLLC
    • Arkansas
      • Little Rock、Arkansas、美国、72205
        • Clinical Trials, Inc.
    • California
      • Berkeley、California、美国、94705
        • East Bay Physicians Medical Group
      • Carson、California、美国、90746
        • AVI Clinical Research
      • Costa Mesa、California、美国、92626
        • ATP Clinical Research, Inc.
      • Encino、California、美国、91316
        • Pharmacology Research Institute
      • Fresno、California、美国、93720
        • Margolin Brain Institute
      • Fullerton、California、美国、92835
        • Neurology Center of North Orange County
      • La Jolla、California、美国、92037
        • University of California San Diego
      • La Jolla、California、美国、92037
        • Coordinated Clinical Research
      • Laguna Hills、California、美国、92653
        • Senior Clinical Trials, Inc.
      • Long Beach、California、美国、90806
        • Collaborative Neuroscience Network, Inc.
      • Los Alamitos、California、美国、90720
        • Pharmacology Research Institute
      • Los Angeles、California、美国、90095
        • UCLA Department of Neurology
      • Newport Beach、California、美国、92660
        • Pharmacology Research Institute
      • Oceanside、California、美国、92056
        • Neurology Center
      • Orange、California、美国、92868
        • University of California, Irvine Medical Center
      • Pasadena、California、美国、91105
        • Neuro-Therapeutics, Inc.
      • Sacramento、California、美国、95816
        • Sutter Neuroscience Medical Group
      • Sacramento、California、美国、95817
        • University of California at Davis, Alzheimer's Disease Research Center
      • San Diego、California、美国、92123
        • Sharp Mesa Vista Hospital
      • San Diego、California、美国、92123
        • Artemis Institute for Clinical Research
      • San Francisco、California、美国、94143
        • University of California San Francisco
      • San Francisco、California、美国、94109
        • San Francisco Clinical Research Center
      • Santa Monica、California、美国、90404
        • Neurological Research Institute
      • Sherman Oaks、California、美国、91403
        • Schuster Medical Research Institute
      • Walnut Creek、California、美国、94596
        • Diablo Clinical Research, Inc
    • Colorado
      • Boulder、Colorado、美国、80304
        • Alpine Clinical Research Center
      • Denver、Colorado、美国、80218
        • Mile High Research Center
      • Fort Collins、Colorado、美国、80528
        • Advanced Neurosciences Research, LLC
    • Connecticut
      • Danbury、Connecticut、美国、06810
        • Associated Neurologists, PC
      • Fairfield、Connecticut、美国、06824
        • Associated Neurologists of Southern Connecticut, P.C.
      • New Haven、Connecticut、美国、06510
        • Yale University School Of Medicine
      • New Haven、Connecticut、美国、06510
        • Institute for Neurodegenerative Disorders
      • Norwalk、Connecticut、美国、06851
        • Research Center for Clinical Studies, Inc.
      • Waterbury、Connecticut、美国、06708
        • Chase Medical Research, LLC
    • Delaware
      • Newark、Delaware、美国、19713
        • Christiana Care Neurology Specialists
    • District of Columbia
      • Washington、District of Columbia、美国、20057
        • Georgetown University Medical Center
    • Florida
      • Atlantis、Florida、美国、33462
        • JEM Research, LLC
      • Bradenton、Florida、美国、34205
        • Bradenton Research Center, Inc.
      • Deerfield Beach、Florida、美国、33064
        • Quantum Laboratories, Inc.
      • Delray Beach、Florida、美国、33445
        • Brain Matters Research
      • Fort Lauderdale、Florida、美国、33308
        • Neurologic Consultants, PA
      • Fort Myers、Florida、美国、33912
        • Neuropsychiatric Research Center of Southwest Florida
      • Fort Myers、Florida、美国、33916
        • Clinical Physiology Associates, Inc
      • Fort Walton Beach、Florida、美国、32547
        • Emerald Coast Mood and Memory, PA.
      • Hallandale Beach、Florida、美国、33009
        • MD Clinical
      • Jacksonville、Florida、美国、32224
        • Mayo Clinic College of Medicine
      • Maitland、Florida、美国、32751
        • Neurology Associates
      • Melbourne、Florida、美国、32901
        • Melbourne Internal Medicine Associates
      • Miami、Florida、美国、33137
        • Miami Jewish Health Systems
      • Miami、Florida、美国、33173
        • Miami Research Associates
      • Miami、Florida、美国、33126
        • Pharmax Research Clinic, LLC
      • Miami、Florida、美国、33156
        • Allied Clinical Trials Inc.
      • Ocala、Florida、美国、34471
        • Renstar Medical Research
      • Orlando、Florida、美国、32806
        • Compass Research, LLC
      • Palm Beach Gardens、Florida、美国、33418
        • Palm Beach Neurological Center, Advanced Research Consultants, Inc.
      • Port Charlotte、Florida、美国、33952
        • Neurostudies, Inc.
      • Saint Petersburg、Florida、美国、33713
        • Suncoast Neuroscience Associates, Inc.
      • Sarasota、Florida、美国、34243
        • The Roskamp Institute, Inc
      • Tampa、Florida、美国、33609
        • Axiom Clinical Research of Florida
      • Tampa、Florida、美国、33613
        • Stedman Clinical Trials, LLC
      • Tampa、Florida、美国、33613
        • Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute
      • Tampa、Florida、美国、33613
        • University of South Florida Suncoast Alzheimer's and Gerontology Center
      • West Palm Beach、Florida、美国、33407
        • Premiere Research Institute
    • Georgia
      • Atlanta、Georgia、美国、30342
        • NeuroTrials Research, Inc.
      • Atlanta、Georgia、美国、30322
        • Emory University, School of Medicine
      • Atlanta、Georgia、美国、30327
        • Multiple Sclerosis Center of Atlanta
      • Columbus、Georgia、美国、31909
        • Medical Research and Health Education Foundation, Inc.
      • Columbus、Georgia、美国、31909
        • Medical Research and Health Education Foundation, Inc
      • Decatur、Georgia、美国、30033
        • Dekalb Neurology Associates, LLC
      • Lawrenceville、Georgia、美国、30045
        • Gwinnett Medical Center
    • Illinois
      • Chicago、Illinois、美国、60637
        • University Of Chicago Medical Center
      • Elk Grove Village、Illinois、美国、60007
        • Alexian Brothers Neuroscience Institute
      • Peoria、Illinois、美国、61602
        • Methodist Medical Center of Illinois
      • Springfield、Illinois、美国、62794
        • Southern Illinois University School of Medicine
    • Indiana
      • Elkhart、Indiana、美国、46514
        • Elkhart Clinic, LLC
      • Indianapolis、Indiana、美国、46202
        • Indiana University School of Medicine
    • Kansas
      • Kansas City、Kansas、美国、66160
        • The University of Kansas Medical Center
      • Lenexa、Kansas、美国、66214
        • MidAmerica Neuroscience Institute
    • Kentucky
      • Lexington、Kentucky、美国、40536
        • University of Kentucky
      • Lexington、Kentucky、美国、40513
        • Associates in Neurology, PSC
      • Paducah、Kentucky、美国、42003
        • Four Rivers Clinical Research, Inc.
    • Louisiana
      • Lake Charles、Louisiana、美国、70629
        • Lake Charles Clinical Trials
      • Shreveport、Louisiana、美国、71104
        • J. Gary Booker, MD, APMC
    • Maine
      • Scarborough、Maine、美国、04074
        • Maine Medical Partners Neurology
    • Maryland
      • Rockville、Maryland、美国、20850
        • CBH Health, LLC
    • Massachusetts
      • Boston、Massachusetts、美国、02118
        • Boston University School of Medicine
      • Boston、Massachusetts、美国、02115
        • Brigham and Women's Hospital, Dept. of Neurology
      • Haverhill、Massachusetts、美国、01830
        • ActivMed Practices and Research, Inc.
      • Newton、Massachusetts、美国、02459
        • Neurocare, Inc.
      • Pittsfield、Massachusetts、美国、01201
        • Neuroscience Research of the Berkshires
      • Plymouth、Massachusetts、美国、02360
        • Donald S. Marks, MD, PC
      • Springfield、Massachusetts、美国、01104
        • Springfield Neurology Associates, LLC
    • Michigan
      • Ann Arbor、Michigan、美国、48105
        • University of Michigan Medical Center
      • Detroit、Michigan、美国、48202
        • Henry Ford Hospital
      • East Lansing、Michigan、美国、48824
        • Michigan State University
      • Kalamazoo、Michigan、美国、49048
        • Borgess Medical Center/Borgess Research Institute
    • Minnesota
      • Rochester、Minnesota、美国、55905
        • Mayo Clinic
    • Mississippi
      • Hattiesburg、Mississippi、美国、39401
        • Hattiesburg Clinic
    • Missouri
      • Kansas City、Missouri、美国、64114
        • Center for Pharmaceutical Research
      • Saint Louis、Missouri、美国、63104
        • Saint Louis University School of Medicine
      • Saint Lous、Missouri、美国、63108
        • Washington University School of Medicine
    • Montana
      • Billings、Montana、美国、59101
        • Deaconess Billings Clinical Research Center
      • Great Falls、Montana、美国、59405
        • Advanced Neurology Specialists
    • Nebraska
      • Omaha、Nebraska、美国、68198
        • University of Nebraska Medical Center
    • New Jersey
      • Eatontown、New Jersey、美国、07724
        • Memory Enhancement Center of America, Inc.
      • Manchester、New Jersey、美国、08759
        • Alzheimer's Research Corporation
      • Princeton、New Jersey、美国、08540
        • Global Medical Institutes, LLC
      • Toms River、New Jersey、美国、08755
        • Shore Neurology, PA
    • New Mexico
      • Albuquerque、New Mexico、美国、87109
        • Albuquerque Neuroscience, Inc.
    • New York
      • Albany、New York、美国、12205
        • Upstate Clinical Research, LLC
      • Albany、New York、美国、12208
        • Neurological Associates of Albany, PC
      • Albany、New York、美国、12208
        • Neuroscience Research Center at Albany Medical Center
      • Elmsford、New York、美国、10523
        • Advanced BioBehavioral Sciences
      • Latham、New York、美国、12110
        • Empire Neurology, PC
      • Liverpool、New York、美国、13088
        • Neurological Care of Central New York
      • New Hyde Park、New York、美国、11040
        • Parker Jewish Institute for Health Care and Rehabilitation
      • New York、New York、美国、10032
        • Columbia University Medical Center
      • New York、New York、美国、10016
        • New York University School of Medicine/Psychiarty
      • Orangeburg、New York、美国、10962
        • Nathan S. Kline Institute for Psychiatric Research
      • Rochester、New York、美国、14620
        • University of Rochester Medical Center, Monroe Community Hospital
    • North Carolina
      • Durham、North Carolina、美国、27710
        • Duke University Medical Center
      • Hickory、North Carolina、美国、28601
        • Clinical Trials of America, Inc
      • Raleigh、North Carolina、美国、27607
        • Raleigh Neurology Associates
    • Ohio
      • Canton、Ohio、美国、44718
        • Neuro-Behavioral Clinical Research, Inc.
      • Columbus、Ohio、美国、43210
        • Ohio State University, Dept. of Neurology
      • Dayton、Ohio、美国、45417
        • Neurology Specialists, Inc.
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73112
        • Lynn Health Science Institute
      • Oklahoma City、Oklahoma、美国、73112
        • Red River Medical Research Center, LLC
    • Oregon
      • Medford、Oregon、美国、97504
        • Providence Medical Group-Medford Neurology
      • Portland、Oregon、美国、97239
        • Oregon Health and Science University
      • Portland、Oregon、美国、97223
        • Summit Research Group, LLC
      • Portland、Oregon、美国、97225
        • Providence Health Service System, AD Center, Brain Institute
    • Pennsylvania
      • Abington、Pennsylvania、美国、19001
        • Abington Neurological Associates, Ltd.
      • Allentown、Pennsylvania、美国、18103
        • Lehigh Valley Health Network
      • Jenkintown、Pennsylvania、美国、19046
        • The Clinical Trial Center, LLC
      • Philadelphia、Pennsylvania、美国、19102
        • Drexel University College of Medicine
      • Philadelphia、Pennsylvania、美国、19104
        • Penn Memory Center
      • Philadelphia、Pennsylvania、美国、19107
        • Jefferson Hospital for Neuroscience
      • Pittsburgh、Pennsylvania、美国、15213
        • University of Pittsburgh
      • Pittsburgh、Pennsylvania、美国、15206
        • Clinical Trials Research Services, LLC
    • Rhode Island
      • East Providence、Rhode Island、美国、02914
        • Rhode Island mood and memory research institute
      • Providence、Rhode Island、美国、02903
        • Rhode Island Hospital
      • Providence、Rhode Island、美国、02906
        • Butler Hospital
    • South Carolina
      • North Charleston、South Carolina、美国、29406
        • Medical University of South Carolina
    • South Dakota
      • Sioux Falls、South Dakota、美国、57105
        • Avera Research Institute
    • Tennessee
      • Cordova、Tennessee、美国、38018
        • Neurology Clinic, P.C.
      • Johnson City、Tennessee、美国、37614
        • East Tennessee State University
      • Knoxville、Tennessee、美国、37920
        • Volunteer Research Group
      • Nashville、Tennessee、美国、37203
        • Psychiatric Consultants, PC
    • Texas
      • Austin、Texas、美国、78757
        • Senior Adults Specialty Research (Sasr)
      • Dallas、Texas、美国、75214
        • Texas Neurology, PA
      • Dallas、Texas、美国、75390
        • University of Texas Southwestern Medical Center, Dept. of Neurology
      • DeSoto、Texas、美国、75115
        • Insite clinical research
      • Fort Worth、Texas、美国、76106
        • University of North Texas Health Science Center at Fort Worth
      • Houston、Texas、美国、77030
        • Baylor College of Medicine
      • San Antonio、Texas、美国、78229
        • Innovative Clinical Trials
      • San Antonio、Texas、美国、78231
        • Integra Clinical Research, Llc
    • Utah
      • Salt Lake City、Utah、美国、84107
        • Wasatch Clinical Research
      • Salt Lake City、Utah、美国、84108
        • University of Utah, Dept. of Neurology
    • Vermont
      • Bennington、Vermont、美国、05201
        • The Memory Clinic
      • Burlington、Vermont、美国、05401
        • Fletcher Allen Health Care
    • Virginia
      • Alexandria、Virginia、美国、22304
        • Innovative Clinical Research Center
      • Charlottesville、Virginia、美国、22903
        • University of Virginia
      • Richmond、Virginia、美国、23230
        • Alliance Research Group, LLC
    • Washington
      • Seattle、Washington、美国、98108
        • University of Washington Veterans Affairs
      • Seattle、Washington、美国、98144
        • Pacific Medical Centers
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53226
        • Medical College of Wisconsin, Froedtert Memorial Lutheran Hospital
      • Waukesha、Wisconsin、美国、53188
        • Independent Psychiatric Consultants

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

51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:

  • Diagnosis of probable AD
  • Must have completed study 301 or study 302; and have completed Visit 15 (Week 78)
  • Brain MRI scan to evaluate safety from Study 301 or 302 at Visit 14/Week 71
  • Caregiver able to attend all clinic visits with patient

Exclusion Criteria:

  • Any new medical contraindication or clinically significant abnormality on physical, neurological, laboratory, vital signs or ECG examination (eg, atrial fibrillation) that precludes continued or initiation of treatment with bapineuzumab or participation in the study
  • Screening visit brain MRI scan (MRI from Study 301 or 302 Visit 14/Week 71) indicative of any significant abnormality not approved by the medical monitor prior to enrollment
  • Current use of experimental medications for AD (other than bapineuzumab) and all other experimental medications, herbal preparations containing Ginko biloba, and anticoagulants (except the use of aspirin 325mg/day or less, Plavix, and Persantine but not for stroke)

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
有源比较器：Bapineuzumab 0.5 mg/kg
0.5 mg/kg
药品：Bapineuzumab

0.5 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.

1.0 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.
有源比较器：Bapineuzumab 1.0 mg/kg
1.0 mg/kg
药品：Bapineuzumab

0.5 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.

1.0 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Clinically important changes in safety assessment results including vital signs, weight, clinical laboratory tests, electrocardiograms (ECGs), brain magnetic resonance imaging (MRI), physical and neurological examinations, and infusion site assessments.
大体时间：Varies according to assessment: vital signs and adverse events on ongoing basis; MRI and ECG as required per protocol
Varies according to assessment: vital signs and adverse events on ongoing basis; MRI and ECG as required per protocol

次要结果测量

结果测量
大体时间
To evaluate the efficacy of long term treatment of IV administered bapineuzumab in subjects with AD.
大体时间：The trial duration is expected to be approximately 4 years. The study will last up to the time of commercial launch of bapineuzumab, or termination of the clinical trials program, whichever comes first
The trial duration is expected to be approximately 4 years. The study will last up to the time of commercial launch of bapineuzumab, or termination of the clinical trials program, whichever comes first

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。

赞助

JANSSEN Alzheimer Immunotherapy Research & Development, LLC

合作者

Pfizer

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7月1日

初级完成 (实际的)

2012年9月1日

研究完成 (实际的)

2012年9月1日

研究注册日期

首次提交

2009年7月7日

首先提交符合 QC 标准的

2009年7月9日

首次发布 (估计)

2009年7月13日

研究记录更新

最后更新发布 (估计)

2013年12月20日

上次提交的符合 QC 标准的更新

2013年11月26日

最后验证

2013年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ELN115727-351

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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