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临床试验/NCT01448148
NCT01448148已完成不适用

Measuring the Impact of Cognitive and Psychosocial Interventions in Persons With Mild Cognitive Impairment

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal4 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2011年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
145
试验地点
4
主要终点
Change in memory measures

研究概览

简要总结

Memory interventions are training programs that provide a variety of cognitive and psychological strategies meant to improve memory. These interventions have been shown to yield significant benefits to normal aged persons and small-size studies have shown that they are suitable and beneficial for persons with mild cognitive impairment. The goal of this proposal is to assess with a well-controlled design the efficiency and specificity of cognitive training in persons with mild cognitive impairment.

The hypothesis is that cognitive training can improve the cognition of persons with mild cognitive impairment and that this improvement can be enduring.

详细描述

Elderly persons with mild cognitive impairment experience a cognitive decline that is confirmed by a neuropsychological examination but do not meet the clinical criteria for dementia. However, longitudinal studies have shown that up to 75% of these persons develop dementia of the Alzheimer type after 5 years of follow-up. A significant proportion of these persons are thus in a prodromal phase of the disease. This phase is likely to represent a key moment in which to apply appropriate interventions. Indeed, these persons have the cognitive capabilities to benefit from such interventions. Cognitive training has been shown to be effective in improving the memory function of older persons without cognitive decline and increasing evidence indicates that persons with MCI might also benefit from such interventions. However, there is few researches have focused on the Mild Cognitive Impairment population in spite of the fact that they are at-risk of experiencing significant cognitive problems in the next few years while still having the potential to benefit from non-pharmacological interventions. In a number of pilot studies, the investigators compared cognitive and psychosocial intervention to a control intervention in persons with MCI. The participants' performance improved on proximal outcomes and on distal outcomes (activities of daily living). The purpose of this project is to study the efficacy of the cognitive intervention in a larger group of participants, compare it with a non-cognitive intervention, assess the long term maintenance of the improvement and measure the potential implication of cognitive and psychosocial factors.

Persons with Mild Cognitive Impairment will first receive a comprehensive clinical assessment to determine whether they meet the research criteria for Mild Cognitive Impairment. They will then be randomly allocated to one of three groups. One group will receive cognitive training, one group will receive psychosocial intervention and one group will receive no intervention. The two interventions will be offered on a one-session per week basis during an 8-week period. The cognitive intervention will include training of attention and episodic memory. This intervention is based on recently acquired knowledge regarding the nature of the deficits in mild cognitive impairment as well as factors that are known to optimize memory. The psychosocial intervention will focus on goal management. Booster sessions will be offered to the intervention groups after 3 and 6 months. Each intervention will act as social contact control group for the other intervention. The third group will receive no intervention and will be used as a no-contact control group.

All groups will undergo one pre-intervention assessment (1-2 week before beginning of intervention), one post-intervention assessment (1-2 week after end of intervention) and additional assessments one week after before the booster sessions and nine month following end of training. This last assessment will measure long-term retention of training and will assess the degree of change in the clinical profile of patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • francophone
  • MCI identified by a doctor
  • normal corrected vision
  • good hearing

排除标准

  • history of neurological disorder
  • major psychiatric illness
  • alcoholism
  • general anesthesia in the previous six months
  • significant impairment of physical mobility

结局指标

主要结局

Change in memory measures

时间窗: one week before and after intervention, and three and six months later

Unrelated word list learning and Face-name memory tests

次要结局

  • Change in psychological health measures(one week before and after intervention, and 3 and 6 months later)
  • generalization of therapeutic gains to everyday life(one week before and after intervention, and three and six months later)

研究者

发起方
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sylvie Belleville

Research director of CRIUGM and full professor at University of Montreal

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

研究点 (4)

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