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The Efficacy of Galantamine on the Attention and the Frontal Function of the Patients With Dementia of Alzheimer Type

2011年1月20日 更新者:Janssen Korea, Ltd., Korea

A Prospective, Open-labeled, Multicenter Study of Galantamine on the Attention and Frontal Function of the Patients With Dementia of Alzheimer Type

The purpose of this study is to assess the efficacy of galantamine on the attention of patients with Alzheimer's Disease, how an improvement of attention of Alzheimer's Disease patients affects their activities of daily living, and the global benefit of galantamine.

研究概览

地位

完全的

详细说明

Recent studies suggest that an attention deficit occurs at early stage of Alzheimer's disease and affects patients' activities of daily living. In other words, some patients without language or visuospatial dysfunction have severe impairment of activities of daily living, which might result from attention deficit. Another recent clinical study showed that galantamine is more effective in attention and vigilance of Alzheimer's disease patients than donepezil. The study hypothesis is that galantamine will improve attention and frontal executive function in Alzheimer's disease patients and is well-tolerated. 8 mg/day for the first 4 weeks, 16 mg for the next 8 weeks

研究类型

介入性

注册 (实际的)

102

阶段

  • 第四阶段

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

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Male or female patients aged 50 years or older
  • Alzheimer's disease according to the criteria of DSM-IV15, NINCDS-ADRDA16
  • Measuring standard MMSE-K 10 to 26
  • Patients who are literate
  • Dementia patients being nursed by the family
  • Patients who submitted written consent before entering into the clinical trial (the guardian consent is also effective)

Exclusion Criteria:

  • If the patient was taking AChEI (Tacrine, Donepezil, Rivastigmine) to treat dementia, the patient can enter into this clinical trial as long as he/she has not taken the drug within 15 days of the beginning of the clinical trial
  • Neurodegenerative diseases (e.g. Parkinson's disease, Pick's disease, Huntington's disease, Down syndrome)
  • Dementia related to head trauma and dementia related to brain damage due to cerebral hypoxia (hypoxic brain damage after cardiopulmonary resuscitation, hypoxic brain damage after surgery, hypoxic brain damage due to addiction, hypoxic brain damage due to shock)
  • brain tumor, nerve syphilis, meningitis, encephalitis, brain tumor
  • amentia
  • epilepsy
  • major psychiatric patients such as major depression and schizophrenia
  • treatment-resistant gastric and peptic ulcer
  • patients with clinically serious hepatic, renal, lung, endocrinal or metabolic disease(thyroid, parathyroid, pituitary, renal failure, diabetes mellitus)
  • patients complaining of severe difficulty in urination
  • patients who have undergone heart surgery within 6 months or patients who experienced myocardial infarction, patients with untreated congestive heart failure, patients with severe disorders in the mitral valve or aortic valve
  • patients who have once taken the investigational drugs within the past 1 month from the beginning day of the clinical trial
  • patients with uncontrolled diabetes mellitus (if the patient is taking medication and consults the doctor on a regular basis, he/she can participate in this clinical trial)
  • patients who experienced hypersensitivity or allergy by a cholinesterase inhibitor
  • patients who have not given their consent to the clinical trial, patients who are judged inappropriate to participate in this clinical trial by the investigator

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:非随机化
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

研究衡量的是什么?

主要结果指标

结果测量
Attention and Executive function: Visual CPT, Visual Span, Color Trail Making test, Stroop test

次要结果测量

结果测量
Cognition: Mini-Mental Sate Examination-Korean version (MMSE-K);Activities of Daily living: Seoul- Instrumental Activities of daily livings (S-IADL);Behavior: NPI-Q;Global Change: Global Deterioration Scale (GDS)

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。

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

2004年3月1日

研究完成 (实际的)

2005年11月1日

研究注册日期

首次提交

2005年9月13日

首先提交符合 QC 标准的

2005年9月13日

首次发布 (估计)

2005年9月22日

研究记录更新

最后更新发布 (估计)

2011年1月24日

上次提交的符合 QC 标准的更新

2011年1月20日

最后验证

2011年1月1日

更多信息

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.

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