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临床试验/NCT00743418
NCT00743418Unknown1 期

The Use of Advanced Tracking Technologies for the Analysis of Mobility in Alzheimer's Disease and Related Cognitive Disorders

Tel-Aviv Sourasky Medical Center2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2007年6月最近更新:
适应症

试验速览

阶段
1 期
入组人数
300
试验地点
2
主要终点
Evaluation tools include: Geriatric Depression Scale, functional health questionnaire (SF-36), Emotional well-being questionnaire (Positive and Negative Affect Schedule; PANAS), single Life Satisfaction question and the Zarit Burden Interview

研究概览

简要总结

The research is aimed at exploring the application of novel tracking technique for the study of spatial activity among dementia patients and its implication on their families. The study sample will be composed of three groups of volunteers, each including100 participants aged over 60 years. The first group will include MCI (Mild Cognitive Impairment) patients. The second group will include patients that suffer from mild dementia. The third group will include age matched healthy participants. The tracking equipment will be a GPS apparatus of 450 gms that will be carried by the participants for 24 hours along 2-4 weeks. The GPS data will be transferred via the cellular network to operator center at the Hebrew university at Jerusalem, and will be documented in assigned data files. This monitoring procedure will be held every year and along a period of five years. The impact of the patient behavior on the care giver will be studied by means of five interviews along the tracking period.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with MCI, Alzheimer's disease, or mixed type dementia; OR
  • Healthy control subjects who meet the following criteria:
  • Mini Mental State (MMSE) of at least 21
  • Age 60 years or older
  • Patients with history of stroke which is not followed by cognitive decline may be included
  • Fluent language skills

排除标准

  • Other dementias (e.g. vascular, frontotemporal, metabolic etc);
  • Other major psychiatric disorders (e.g. major depression, schizophrenia);
  • Substance abuse;
  • MMSE 20 or less;
  • Severe motor disturbances;
  • Sensory deficits potentially affecting mobility; OR
  • Severe physical disorders (e.g. cancer, major operation)

结局指标

主要结局

Evaluation tools include: Geriatric Depression Scale, functional health questionnaire (SF-36), Emotional well-being questionnaire (Positive and Negative Affect Schedule; PANAS), single Life Satisfaction question and the Zarit Burden Interview

时间窗: Before and after interventions

次要结局

未报告次要终点

研究者

申办方类型
Other Gov

研究点 (2)

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