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

2013년 11월 26일 업데이트: 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.

연구 개요

상태

종료됨

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

896

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

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

51년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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)

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: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Bapineuzumab 0.5 mg/kg
0.5 mg/kg
의약품: 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.
활성 비교기: Bapineuzumab 1.0 mg/kg
1.0 mg/kg
의약품: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
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.
기간: 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

2차 결과 측정

결과 측정
기간
To evaluate the efficacy of long term treatment of IV administered bapineuzumab in subjects with AD.
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

JANSSEN Alzheimer Immunotherapy Research & Development, LLC

협력자

Pfizer

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

2009년 7월 1일

기본 완료 (실제)

2012년 9월 1일

연구 완료 (실제)

2012년 9월 1일

연구 등록 날짜

최초 제출

2009년 7월 7일

QC 기준을 충족하는 최초 제출

2009년 7월 9일

처음 게시됨 (추정)

2009년 7월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2013년 12월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2013년 11월 26일

마지막으로 확인됨

2013년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • ELN115727-351

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. .

알츠하이머병에 대한 임상 시험

Bapineuzumab에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Romania

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다