A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease
2010년 8월 25일 업데이트: Forest Laboratories
A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Memantine in Patients With Moderate-to-Severe Dementia of the Alzheimer's Type
The objective of this study is to evaluate the safety, tolerability, and efficacy of memantine compared to placebo in outpatients diagnosed with moderate-to-severe dementia of the Alzheimer's type on a concurrent acetylcholinesterase inhibitor (AChEI).
연구 개요
상세 설명
Memantine is a therapeutic agent that represents a unique class of Alzheimer's disease (AD) treatment options.
A once daily (QD) dosing regimen in an AD population would simplify administration for the caregiver.
The purpose of this study is to evaluate the safety and efficacy of modified release memantine taken once daily in outpatients with moderate-to-severe AD on a concurrent AChEI.
연구 유형
중재적
등록 (실제)
677
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Aguascalientes, 멕시코, 20230
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San Luis Potosi, 멕시코, 78090
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Coahuila
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Saltillo, Coahuila, 멕시코, 25000
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Federal District
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Mexico City, Federal District, 멕시코, 14000
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Mexico City, Federal District, 멕시코, 14050
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Guanajuato
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Leon, Guanajuato, 멕시코, 37000
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Jalisco
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Guadalajara, Jalisco, 멕시코, 44610
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Zapopan, Jalisco, 멕시코, 45200
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Nuevo Leon
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Monterrey, Nuevo Leon, 멕시코, 44610
- Forest Investigative Site 208
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Monterrey, Nuevo Leon, 멕시코, 64710
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Sinaloa
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Culiacan, Sinaloa, 멕시코, 80400
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Arizona
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Phoenix, Arizona, 미국, 85004
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California
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Costa Mesa, California, 미국, 92626
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Fresno, California, 미국, 93720
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San Francisco, California, 미국, 94118
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Santa Ana, California, 미국, 92705
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Colorado
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Denver, Colorado, 미국, 80262
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Florida
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Boca Raton, Florida, 미국, 33486
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Boynton Beach, Florida, 미국, 33426
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Delray Beach, Florida, 미국, 33445
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Fort Myers, Florida, 미국, 33912
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Hallandale Beach, Florida, 미국, 33009
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Hallandale Beach, Florida, 미국, 33009
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Miami, Florida, 미국, 33137
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North Miami, Florida, 미국, 33161
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Orlando, Florida, 미국, 32806
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Palm Beach Gardens, Florida, 미국, 33410
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Saint Petersburg, Florida, 미국, 33709
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Tampa, Florida, 미국, 33617
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Georgia
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Snellville, Georgia, 미국, 30078
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Illinois
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Joliet, Illinois, 미국, 60435
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Michigan
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Kalamazoo, Michigan, 미국, 49048
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Missouri
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Saint Loius, Missouri, 미국, 63104
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New Jersey
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Long Branch, New Jersey, 미국, 07742
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Morristown, New Jersey, 미국, 07960
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New Brunswick, New Jersey, 미국, 08903
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New York
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Albany, New York, 미국, 12205
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Buffalo, New York, 미국, 14215
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White Plains, New York, 미국, 10605
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Ohio
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Centerville, Ohio, 미국, 45459
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Toledo, Ohio, 미국, 43623
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Oregon
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Portland, Oregon, 미국, 97210
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Pennsylvania
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Greensburg, Pennsylvania, 미국, 15601
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Jenkintown, Pennsylvania, 미국, 19046
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Rhode Island
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East Providence, Rhode Island, 미국, 02914
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Texas
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Austin, Texas, 미국, 78757
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San Antonio, Texas, 미국, 78229
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Virginia
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Richmond, Virginia, 미국, 23229
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Washington
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Tacoma, Washington, 미국, 98405
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Buenos Aires, 아르헨티나, 1419HDN
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Buenos Aires, 아르헨티나, C1062ABF
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Buenos Aires, 아르헨티나, C1117ABE
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Buenos Aires, 아르헨티나, C1122AAJ
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Buenos Aires, 아르헨티나, C1126AAB
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Buenos Aires, 아르헨티나, C1181ACH
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Buenos Aires, 아르헨티나, C1209AAB
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Buenos Aires, 아르헨티나, C1405CNF
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Buenos Aires, 아르헨티나, C1413FWO
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Buenos Aires, 아르헨티나, C1419AHN
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Buenos Aires, 아르헨티나, C1425AGP
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Buenos Aires, 아르헨티나, C1425BPK
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Buenos Aires, 아르헨티나, C1428AQK
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Buenos Aires, 아르헨티나, C1428AQK
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Cordoba, 아르헨티나, X5000ALB
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Cordoba, 아르헨티나, X5004AOA
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Mendoza, 아르헨티나, M5500HYF
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Mendoza, 아르헨티나, M5504FMI
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Santa Fe, 아르헨티나, S3000FWO
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Buenos Aires
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Banfield, Buenos Aires, 아르헨티나, B1828CKR
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La Plata, Buenos Aires, 아르헨티나, B1900AVG
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Lanus, Buenos Aires, 아르헨티나, C1824IBR
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Santa Fe
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Rosario, Santa Fe, 아르헨티나, S2000DSV
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Antofagasta, 칠레
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Santiago, 칠레
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Santiago, 칠레
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Valdivia, 칠레
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Elqui
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Coquimbo, Elqui, 칠레
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Santiago
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Las Condes, Santiago, 칠레
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Las Condes, Santiago, 칠레
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Providencia, Santiago, 칠레
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Providencia, Santiago, 칠레
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Recoleta, Santiago, 칠레
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San Ramon, Santiago, 칠레
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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
50년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Ambulatory patients aged >/= 50 years
- Diagnostic evidence of probable Alzheimer's disease consistent with criteria from the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
- Confirmatory magnetic resonance imaging (MRI) or computed tomographic (CT) scan within the prior 12 months.
- Mini-Mental State Examination (MMSE) scores >/= 3 and </= 14 at Screening (Visit 1) and Baseline (Visit 2)
- Ongoing daily acetylcholinesterase inhibitor (AChEI) therapy at a stable dose for at least 3 months prior to Screening (Visit 1). It is preferred that patients continue to receive the same AChEI therapy for the duration of the study.
Exclusion Criteria:
- Patients with a modified Hachinski Ischemia Score greater than 4 at Screening.
- Patients who have taken memantine within one month of Screening (Visit 1)
- Patients who have a known hypersensitivity to memantine, neramexane, rimantadine, or amantadine.
- Patients whose AChEI therapy is likely to be interrupted or discontinued during the course of the study.
- Patients who are receiving therapy with more than one AChEI.
- Patients with computed tomography (CT) or magnetic resonance imaging (MRI) evidence of hydrocephalus, stroke, a space-occupying lesion, cerebral infection, or any clinically significant central nervous system disease other than Alzheimer's disease.
- Patients with a DSM-IV Axis I disorder other than Alzheimer's disease, including amnestic disorders, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, or post-traumatic stress disorder.
- Patients who, in the clinician's judgement, are likely to be placed in a nursing home within the next 6 months.
- Patients who had evidence of other neurological disorders that included, but were not limited to, stroke, Parkinson's disease, seizure disorder, or head injury with loss of consciousness within the prior 5 years
- Patients who had dementia that was complicated by other organic disease
- Patients who had dementia complicated by the presence of predominant delusions
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 |
|---|---|
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위약 비교기: Placebo
Oral administration, once daily.
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Matching placebo oral administration once daily.
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활성 비교기: Memantine ER
28mg, once daily.
Oral administration for 24 weeks.
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28mg(7mg capsules) once daily and oral administration for 24 weeks.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF)
기간: Baseline to week 24
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The SIB was developed for the evaluation of cognitive function in patients with more advanced dementia, and evaluates the areas of memory, language, praxis, orientation, and attention.
The SIB test items consist of simple, one-step commands presented with gestural cues that are repeated if necessary.
The test contains 51 items, and the range of possible scores is 0 to 100 (with 0 being the worst result).
The SIB has been shown to be a valid and reliable instrument sensitive to longitudinal change.
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Baseline to week 24
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Clinician's Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF)
기간: Week 24
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The CIBIC-Plus is a measure of an overall clinical effect and is based on a comprehensive evaluation at Baseline and later visits of four domains: general (overall clinical status), functional (including activities of daily living), cognitive, and behavioral.
A skilled clinician interviews the patient, and includes information supplied by a knowledgeable caregiver.
The CIBIC-Plus is a rating of the patient's global status relative to Baseline, ranging from a score of 1, indicating "marked improvement" to a score of 4, indicating "no change" to a score of 7, indicating "marked worsening."
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Week 24
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change From Baseline in the 19-Item Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL19) Scale at Week 24 (LOCF)
기간: Baseline to week 24
|
The ADCS-ADL19 modified inventory consists of 19 items used to measure the functional capabilities of patients with moderate to severe dementia.
Each activity-of-daily-living (ADL) item comprises a series of hierarchical subquestions ranging from the highest level of independent performance to complete loss of ability to perform the ADL Inventory.
The inventory is performed by interviewing a person in close contact with the patient and covers the most usual and consistent performance of the patient over the preceding 4 weeks.
Response range is 0 (total disability) to 54 (total independence).
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Baseline to week 24
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Stephen M Graham, PhD, Forest Laboratories
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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
2005년 6월 1일
기본 완료 (실제)
2007년 10월 1일
연구 완료 (실제)
2008년 1월 1일
연구 등록 날짜
최초 제출
2006년 5월 3일
QC 기준을 충족하는 최초 제출
2006년 5월 4일
처음 게시됨 (추정)
2006년 5월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2010년 9월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2010년 8월 25일
마지막으로 확인됨
2010년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- MEM-MD-50
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. .
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