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A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease

2010年8月25日 更新者：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).

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

677

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

  • 墨西哥
      • Aguascalientes、墨西哥、20230
        • Forest Investigative Site 206
      • San Luis Potosi、墨西哥、78090
        • Forest Investigative Site 210
    • Coahuila
      • Saltillo、Coahuila、墨西哥、25000
        • Forest Investigative Site 212
    • Federal District
      • Mexico City、Federal District、墨西哥、14000
        • Forest Investigative Site 202
      • Mexico City、Federal District、墨西哥、14050
        • Forest Investigative Site 207
    • Guanajuato
      • Leon、Guanajuato、墨西哥、37000
        • Forest Investigative Site 211
    • Jalisco
      • Guadalajara、Jalisco、墨西哥、44610
        • Forest Investigative Site 205
      • Zapopan、Jalisco、墨西哥、45200
        • Forest Investigative Site 203
    • Nuevo Leon
      • Monterrey、Nuevo Leon、墨西哥、44610
        • Forest Investigative Site 208
      • Monterrey、Nuevo Leon、墨西哥、64710
        • Forest Investigative Site 204
    • Sinaloa
      • Culiacan、Sinaloa、墨西哥、80400
        • Forest Investigative Site 213
  • 智利
      • Antofagasta、智利
        • Forest Investigative Site 302
      • Santiago、智利
        • Forest Investigative Site 304
      • Santiago、智利
        • Forest Investigative Site 312
      • Valdivia、智利
        • Forest Investigative Site 306
    • Elqui
      • Coquimbo、Elqui、智利
        • Forest Investigative Site 308
    • Santiago
      • Las Condes、Santiago、智利
        • Forest Investigative Site 301
      • Las Condes、Santiago、智利
        • Forest Investigative Site 309
      • Providencia、Santiago、智利
        • Forest Investigative Site 303
      • Providencia、Santiago、智利
        • Forest Investigative Site 310
      • Recoleta、Santiago、智利
        • Forest Investigative Site 313
      • San Ramon、Santiago、智利
        • Forest Investigative Site 305
  • 美国
    • Arizona
      • Phoenix、Arizona、美国、85004
        • Forest Investigative Site 010
    • California
      • Costa Mesa、California、美国、92626
        • Forest Investigative Site 062
      • Fresno、California、美国、93720
        • Forest Investigative Site 050
      • San Francisco、California、美国、94118
        • Forest Investigative Site 024
      • Santa Ana、California、美国、92705
        • Forest Investigative Site 071
    • Colorado
      • Denver、Colorado、美国、80262
        • Forest Investigative Site 002
    • Florida
      • Boca Raton、Florida、美国、33486
        • Forest Investigative Site 021
      • Boynton Beach、Florida、美国、33426
        • Forest Investigative Site 052
      • Delray Beach、Florida、美国、33445
        • Forest Investigative Site 070
      • Fort Myers、Florida、美国、33912
        • Forest Investigative Site 065
      • Hallandale Beach、Florida、美国、33009
        • Forest Investigative Site 043
      • Hallandale Beach、Florida、美国、33009
        • Forest Investigative Site 044
      • Miami、Florida、美国、33137
        • Forest Investigative Site 001
      • North Miami、Florida、美国、33161
        • Forest Investigative Site 034
      • Orlando、Florida、美国、32806
        • Forest Investigative Site 068
      • Palm Beach Gardens、Florida、美国、33410
        • Forest Investigative Site 038
      • Saint Petersburg、Florida、美国、33709
        • Forest Investigative Site 008
      • Tampa、Florida、美国、33617
        • Forest Investigative Site 028
    • Georgia
      • Snellville、Georgia、美国、30078
        • Forest Investigative Site 009
    • Illinois
      • Joliet、Illinois、美国、60435
        • Forest Investigative Site 069
    • Michigan
      • Kalamazoo、Michigan、美国、49048
        • Forest Investigative Site 045
    • Missouri
      • Saint Loius、Missouri、美国、63104
        • Forest Investigative Site 014
    • New Jersey
      • Long Branch、New Jersey、美国、07742
        • Forest Investigative Site 064
      • Morristown、New Jersey、美国、07960
        • Forest Investigative Site 011
      • New Brunswick、New Jersey、美国、08903
        • Forest Investigative Site 003
    • New York
      • Albany、New York、美国、12205
        • Forest Investigative Site 048
      • Buffalo、New York、美国、14215
        • Forest Investigative Site 006
      • White Plains、New York、美国、10605
        • Forest Investigative Site 004
    • Ohio
      • Centerville、Ohio、美国、45459
        • Forest Investigative Site 027
      • Toledo、Ohio、美国、43623
        • Forest Investigative Site 012
    • Oregon
      • Portland、Oregon、美国、97210
        • Forest Investigative Site 020
    • Pennsylvania
      • Greensburg、Pennsylvania、美国、15601
        • Forest Investigative Site 032
      • Jenkintown、Pennsylvania、美国、19046
        • Forest Investigative Site 018
    • Rhode Island
      • East Providence、Rhode Island、美国、02914
        • Forest Investigative Site 067
    • Texas
      • Austin、Texas、美国、78757
        • Forest Investigative Site 041
      • San Antonio、Texas、美国、78229
        • Forest Investigative Site 017
    • Virginia
      • Richmond、Virginia、美国、23229
        • Forest Investigative Site 013
    • Washington
      • Tacoma、Washington、美国、98405
        • Forest Investigative Site 026
  • 阿根廷
      • Buenos Aires、阿根廷、1419HDN
        • Forest Investigative Site 102
      • Buenos Aires、阿根廷、C1062ABF
        • Forest Investigative Site 118
      • Buenos Aires、阿根廷、C1117ABE
        • Forest Investigative Site 109
      • Buenos Aires、阿根廷、C1122AAJ
        • Forest Investigative Site 104
      • Buenos Aires、阿根廷、C1126AAB
        • Forest Investigative Site 108
      • Buenos Aires、阿根廷、C1181ACH
        • Forest Investigative Site 114
      • Buenos Aires、阿根廷、C1209AAB
        • Forest Investigative Site 106
      • Buenos Aires、阿根廷、C1405CNF
        • Forest Investigative Site 119
      • Buenos Aires、阿根廷、C1413FWO
        • Forest Investigative Site 122
      • Buenos Aires、阿根廷、C1419AHN
        • Forest Investigative Site 107
      • Buenos Aires、阿根廷、C1425AGP
        • Forest Investigative Site 111
      • Buenos Aires、阿根廷、C1425BPK
        • Forest Investigative Site 121
      • Buenos Aires、阿根廷、C1428AQK
        • Forest Investigative Site 115
      • Buenos Aires、阿根廷、C1428AQK
        • Forest Investigative Site 116
      • Cordoba、阿根廷、X5000ALB
        • Forest Investigative Site 112
      • Cordoba、阿根廷、X5004AOA
        • Forest Investigative Site 124
      • Mendoza、阿根廷、M5500HYF
        • Forest Investigative Site 110
      • Mendoza、阿根廷、M5504FMI
        • Forest Investigative Site 125
      • Santa Fe、阿根廷、S3000FWO
        • Forest Investigative Site 120
    • Buenos Aires
      • Banfield、Buenos Aires、阿根廷、B1828CKR
        • Forest Investigative Site 103
      • La Plata、Buenos Aires、阿根廷、B1900AVG
        • Forest Investigative Site 105
      • Lanus、Buenos Aires、阿根廷、C1824IBR
        • Forest Investigative Site 123
    • Santa Fe
      • Rosario、Santa Fe、阿根廷、S2000DSV
        • Forest Investigative Site 113

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

50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:

  • 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

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
安慰剂比较：Placebo
Oral administration, once daily.
药品：Placebo
Matching placebo oral administration once daily.
有源比较器：Memantine ER
28mg, once daily. Oral administration for 24 weeks.
药品：memantine ER
28mg(7mg capsules) once daily and oral administration for 24 weeks.
其他名称：
  • 名门达XR

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF)
大体时间：Baseline to week 24
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.
Baseline to week 24
Clinician's Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF)
大体时间：Week 24
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."
Week 24

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline in the 19-Item Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL19) Scale at Week 24 (LOCF)
大体时间：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).
Baseline to week 24

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

Forest Laboratories

调查人员

  • 研究主任：Stephen M Graham, PhD、Forest Laboratories

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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

2005年6月1日

初级完成 (实际的)

2007年10月1日

研究完成 (实际的)

2008年1月1日

研究注册日期

首次提交

2006年5月3日

首先提交符合 QC 标准的

2006年5月4日

首次发布 (估计)

2006年5月5日

研究记录更新

最后更新发布 (估计)

2010年9月16日

上次提交的符合 QC 标准的更新

2010年8月25日

最后验证

2010年8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

  • MEM-MD-50

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.

Placebo的临床试验

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赞助者和合作者

医疗条件

药物干预

CROs by country

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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