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Effect of LY2062430 on the Progression of Alzheimer's Disease (EXPEDITION)

2012년 9월 18일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (예상)

1000

단계

  • 3단계

연락처 및 위치

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

연구 장소

  • 미국
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      • Phoenix, Arizona, 미국, 85006
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      • Sun City, Arizona, 미국, 85351
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      • Tuscon, Arizona, 미국, 85718
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    • Arkansas
      • Little Rock, Arkansas, 미국, 72205
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    • California
      • Carson, California, 미국, 90746
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      • Irvine, California, 미국, 92697
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      • Laguna Hills, California, 미국, 92653
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      • Lomita, California, 미국, 90717
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      • Orange, California, 미국, 92868
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      • Oxnard, California, 미국, 93030
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      • Santa Ana, California, 미국, 92705
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    • Colorado
      • Denver, Colorado, 미국, 80239
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    • Connecticut
      • Fairfield, Connecticut, 미국, 06824
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      • Hamden, Connecticut, 미국, 06518
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      • New Haven, Connecticut, 미국, 06510
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      • Norwalk, Connecticut, 미국, 06851
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    • Delaware
      • Newark, Delaware, 미국, 19713
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    • District of Columbia
      • Washington, District of Columbia, 미국, 20007
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    • Florida
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      • Fort Myers, Florida, 미국, 33912
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      • Hollywood, Florida, 미국, 33021
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      • Miami Springs, Florida, 미국, 33166
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      • North Miami, Florida, 미국, 33161
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      • Orange City, Florida, 미국, 32763
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      • Orlando, Florida, 미국, 32806
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      • Sunrise, Florida, 미국, 33351
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      • Tampa, Florida, 미국, 33613
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    • Georgia
      • Atlanta, Georgia, 미국, 30341
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      • Canton, Georgia, 미국, 30114
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      • Decatur, Georgia, 미국, 30033
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    • Indiana
      • Indianapolis, Indiana, 미국, 46202
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    • Kentucky
      • Lexington, Kentucky, 미국, 40503
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    • Maryland
      • Baltimore, Maryland, 미국, 21285
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      • Rockville, Maryland, 미국, 20852
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    • Massachusetts
      • Belmont, Massachusetts, 미국, 02478
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    • Michigan
      • Grand Rapids, Michigan, 미국, 49525
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      • Traverse City, Michigan, 미국, 49684
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    • New Mexico
      • Albuquerque, New Mexico, 미국, 87109
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    • New York
      • Albany, New York, 미국, 12205
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      • Bronx, New York, 미국, 10454
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      • Latham, New York, 미국, 12210
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      • New York, New York, 미국, 10032
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      • Orangeburg, New York, 미국, 10962
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    • North Carolina
      • Raleigh, North Carolina, 미국, 27607
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      • Winston-Salem, North Carolina, 미국, 27103
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    • Ohio
      • Beachwood, Ohio, 미국, 44122
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      • Toledo, Ohio, 미국, 43623
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    • Oklahoma
      • Oklahoma City, Oklahoma, 미국, 73116
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    • Oregon
      • Eugene, Oregon, 미국, 97401
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    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19104
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    • Rhode Island
      • East Providence, Rhode Island, 미국, 02914
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    • South Carolina
      • Charleston, South Carolina, 미국, 29425
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      • Greer, South Carolina, 미국, 29651
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    • South Dakota
      • Sioux Falls, South Dakota, 미국, 57105
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    • Utah
      • Salt Lake City, Utah, 미국, 84108
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    • Vermont
      • Bennington, Vermont, 미국, 05201
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      • Burlington, Vermont, 미국, 05401
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    • Virginia
      • Norfolk, Virginia, 미국, 23502
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      • Roanoke, Virginia, 미국, 24018
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  • 브라질
      • Curitiba, 브라질, 81210-310
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      • Itapira, 브라질, 13970-905
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      • Porto Alegre, 브라질, 90110-270
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      • Rio De Janeiro, 브라질, 20941-150
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      • São Paulo, 브라질, 04024-002
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  • 아르헨티나
      • Buenos Aires, 아르헨티나, CBA 1419
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      • Cordoba, 아르헨티나, X5004AOA
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      • Mendoza, 아르헨티나, 5500
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      • Pueyrredon Cordoba, 아르헨티나, X5005ALB
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      • Rosario, 아르헨티나, S2000BZL
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      • Santa Fe, 아르헨티나, S3000FWO
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  • 일본
      • Aichi, 일본, 474-8511
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      • Fukuoka, 일본, 812-0033
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      • Hiroshima, 일본, 720-0825
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      • Kanagawa, 일본, 243-8550
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      • Kyoto, 일본, 607-8062
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      • Osaka, 일본, 567
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      • Shizuoka, 일본, 420-8688
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      • Tokyo, 일본, 187-8551
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  • 캐나다
    • Alberta
      • Medicine Hat, Alberta, 캐나다, T1B4E7
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    • British Columbia
      • Kelowna, British Columbia, 캐나다, V1Y3G8
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      • Penticton, British Columbia, 캐나다, V2A5C8
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    • Ontario
      • Ottawa, Ontario, 캐나다, K1N 5C8
        • 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.
      • Toronto, Ontario, 캐나다, M6M 3Z5
        • 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.
    • Quebec
      • Greenfield Park, Quebec, 캐나다, J4V 2J2
        • 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.
      • Sherbrooke, Quebec, 캐나다, J1H1Z1
        • 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.

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

55년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

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
위약 비교기: 위약
의약품: 위약
80주 동안 4주마다 정맥 주사(IV)
실험적: LY2062430
의약품: LY2062430
80주 동안 4주마다 400mg 정맥 주사(IV)
다른 이름들:
  • 베타 항체
  • Solanezumab(*USAN 채택 이름, INN 보류 중)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Change from baseline to endpoint in Alzheimer's Disease Assessment Scale-Cognitive subscore (ADAS-Cog11)
기간: Baseline, 80 weeks
Baseline, 80 weeks
Change from baseline to endpoint in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL)
기간: Baseline, 80 weeks
Baseline, 80 weeks

2차 결과 측정

결과 측정
기간
Change from baseline to endpoint in Clinical Dementia Rating-Sum of Boxes (CDR-SB)
기간: Baseline, 80 weeks
Baseline, 80 weeks
Change from baseline to endpoint in Neuropsychiatric Inventory (NPI)
기간: Baseline, 80 weeks
Baseline, 80 weeks
Change from baseline to endpoint in volumetric magnetic resonance imaging (vMRI)
기간: Baseline, 80 weeks
Baseline, 80 weeks
Change from baseline to endpoint in Mini-Mental State Examination (MMSE)
기간: Baseline, 80 weeks
Baseline, 80 weeks
Change from baseline to endpoint in Resource Utilization in Dementia-Lite (RUD-Lite)
기간: 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)
기간: Baseline, 80 weeks
Baseline, 80 weeks
Change from baseline to endpoint in Quality of Life in Alzheimer's Disease (QoL-AD)
기간: 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.
기간: Baseline, 80 weeks
Baseline, 80 weeks
Change from baseline to endpoint in plasma A Beta
기간: Baseline, 80 weeks
Baseline, 80 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Eli Lilly and Company

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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 5월 1일

기본 완료 (실제)

2012년 4월 1일

연구 완료 (실제)

2012년 4월 1일

연구 등록 날짜

최초 제출

2009년 5월 18일

QC 기준을 충족하는 최초 제출

2009년 5월 18일

처음 게시됨 (추정)

2009년 5월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2012년 9월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2012년 9월 18일

마지막으로 확인됨

2012년 5월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 6747
  • H8A-MC-LZAM (기타 식별자: Eli Lilly and Company)

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

LY2062430에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Cyprus

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다