A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease (NSAID Study)
A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease
연구 개요
상세 설명
Evidence that inflammatory mechanisms contribute to neuronal injury in Alzheimer's disease along with a number of epidemiological studies suggests that non-steroidal anti-inflammatory drugs (NSAIDs) may slow the rate of cognitive deterioration. We have selected two such drugs for a therapeutic trial: rofecoxib and naproxen. The trial employs a double-blind parallel design with three primary treatment groups: rofecoxib, naproxen and placebo. A total of 320 patients will be enrolled in the trial and randomized to the three groups. Stable use of cholinesterase inhibitors, estrogen, low dose aspirin, and vitamin E will be allowed. Patients with inflammatory diseases that might respond to the study medications will be excluded.
The primary outcome measure will be the one year change in the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAScog). The attainment of significant endpoints will be examined as a secondary outcome measure. Other secondary measures include the CDR sum-of-boxes, Neuropsychiatric Inventory, the Quality of Life-AD and the ADCS pharmacoeconomic scale. The influence of HLA-DR (Human Leukocyte Antigen) genotype on clinical progression and response to treatment will also be examined.
연구 유형
단계
- 2 단계
- 3단계
연락처 및 위치
연구 장소
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Arizona
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Phoenix, Arizona, 미국, 85013
- Barrow Neurological Group
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Tucson, Arizona, 미국, 85724-5023
- University of Arizona, Tucson
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California
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Irvine, California, 미국, 92697-4285
- University of California Irvine Institute for Brain Aging and Dementia
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La Jolla, California, 미국, 92037
- University of California, San Diego
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Los Angeles, California, 미국, 90033-1039
- University of Southern California
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Los Angeles, California, 미국, 90095-1769
- University of California, Los Angeles
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Martinez, California, 미국, 94553
- University of California, Davis
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Connecticut
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New Haven, Connecticut, 미국, 06520
- Yale University, School of Medicine
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District of Columbia
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Washington, District of Columbia, 미국, 20007
- Georgetown University Medical Center
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Florida
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Boca Raton, Florida, 미국, 33486
- Baumel-Eisner Neuromedical Institute, Boca Raton
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Ft Lauderdale, Florida, 미국, 33321
- Baumel-Eisner Ft Lauderdale
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Jacksonville, Florida, 미국, 32225
- Mayo Clinic Jacksonville
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Miami Beach, Florida, 미국, 33140
- Wein Center
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Miami Beach, Florida, 미국, 33154
- Baumel-Eisner Neuromedical Institute, MiamiBeach
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Tampa, Florida, 미국, 33617
- University Of South Florida
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West Palm Beach, Florida, 미국, 33407
- Premiere Research Institute
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Georgia
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Atlanta, Georgia, 미국, 30329
- Emory University
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Illinois
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Chicago, Illinois, 미국, 60612
- Rush Presbyterian St. Luke's Medical Center
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Indiana
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Indianapolis, Indiana, 미국, 46202-5266
- Indiana University Medical Center
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Kansas
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Kansas City, Kansas, 미국, 66160
- Kansas University
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Kentucky
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Lexington, Kentucky, 미국, 40536-0230
- University of Kentucky
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Michigan
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Ann Arbor, Michigan, 미국, 48109
- University of Michigan
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Minnesota
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Minneapolis, Minnesota, 미국, 55455
- University of Minnesota
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Missouri
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St. Louis, Missouri, 미국, 63108-2293
- Washington University
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Nevada
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Las Vegas, Nevada, 미국, 89102
- University of Nevada
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New Jersey
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Summit, New Jersey, 미국, 07901
- ClinSearch, Inc
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New York
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New York, New York, 미국, 10016
- New York University Medical Center
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New York, New York, 미국, 10032
- Columbia University
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Rochester, New York, 미국, 14620
- University of Rochester Medical Center
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Ohio
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Cleveland, Ohio, 미국, 44120
- University Hospitals of Cleveland
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Oregon
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Portland, Oregon, 미국, 97201-3098
- Oregon Health Sciences University
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- University of Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15213
- University of Pittsburgh
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Rhode Island
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Providence, Rhode Island, 미국, 02906
- Memorial Hospital of Rhode Island
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South Carolina
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North Charleston, South Carolina, 미국, 29406
- Medical University of South Carolina
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Tennessee
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Nashville, Tennessee, 미국, 37212-8646
- Vanderbilt University Medical Center
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Texas
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Dallas, Texas, 미국, 75390-9070
- University of Texas, SW Medical Center
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Houston, Texas, 미국, 77030
- Baylor College of Medicine
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Vermont
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Bennington, Vermont, 미국, 05201
- Southwestern Vermont Medical Center
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Washington
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Seattle, Washington, 미국, 98108
- University of Washington
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- NINCDS/ADRDA criteria for probable AD
- MMSE between 13 and 26, inclusive
- Stable medical condition for 3 months
- Screening visit
- Physically acceptable for this study as confirmed by medical history, physical exam, neurologic exam, and clinical laboratory tests
- Supervision available for administration of study medications; caregiver/informant to accompany patient to all scheduled visits
- Fluent in English or Spanish
- Age greater than or equal to 55 years old
- Modified Hachinski of less than or equal to 4
- CT or MRI since onset of memory impairment demonstrating absence of clinically significant focal lesion
- Able to complete baseline assessments
- 6 years of education or work history sufficient to exclude mental retardation
- Able to ingest oral medication
Exclusion Criteria:
- Hypersensitivity to aspirin or NSAID
- Active peptic ulcer disease within 5 years
- Renal insufficiency with creatinine greater than 1.5
- Clinically significant liver disease
- Poorly controlled hypertension
- Congestive heart failure
- Bleeding ulcer
- Active neoplastic disease (skin tumors other than melanoma are not exclusionary; patients with stable prostate cancer may be included at the discretion of the project director)
- Inflammatory diseases (including crystal arthropathy, rheumatoid arthritis, systemic lupus, erythematosus, Sjogren's syndrome, inflammatory bowel disease)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 마스킹: 더블
공동 작업자 및 조사자
수사관
- 수석 연구원: Leon Thal, MD, Alzheimer's Disease Cooperative Study
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- IA0021
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. .
나프록센에 대한 임상 시험
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Rutgers, The State University of New JerseyMonell Chemical Senses Center완전한건강한 참가자의 이부프로펜 용액 경구 헹굼 없이 또는 사용하여 단맛 수용체 치료 | 건강한 참가자의 나프록센 용액 경구 헹굼 유무에 관계없이 단맛 수용체의 치료미국