跳至主要内容
临床试验/NCT03991624
NCT03991624终止不适用

Lack of Decision-making in Patients With Alzheimer's Disease : Functions Involved and the Daily Consequences

Centre Hospitalier Universitaire de Saint Etienne8 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年9月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
100
试验地点
8
主要终点
Score obtained (the number of correct answers) by participants in tasks evaluating decision-making

研究概览

简要总结

Early in its development, Alzheimer's disease causes not only brain damage affecting different regions of the brain, such as the entorhinal cortex, the anterior cingulate cortex, and the prefrontal lobe, but also a cognitive deficit affecting several functions, such as episodic memory, executive functions, or working memory. Although these different areas and functions are involved in the decision-making process, few studies have focused their research on this subject in the context of Alzheimer's disease. However, a 2008 study showed an early decline in decision-making skills in the disease, but did not link this deficit to cognitive impairment. In addition, decision-making is generally assessed using a test called the Iowa Gambling Task (IGT), which, despite its many advantages, does not have established ecological validity.

In the context of pathology, however, it seems essential to evaluate decision-making in relation to daily life, especially since a deficit in this process would have considerable repercussions on quality of life.

In this study, the investigators seek to better define the disorder by decision-making in early Alzheimer's disease, to understand the links between them with the deficit of other cognitive functions, and to highlight the the consequences that this decline has on patients' daily lives.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
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

  • for patients with Alzheimer's disease :
  • Mini-Mental State Examination > 23
  • stable treatment for at least two months
  • mother tongue : French
  • Inclusion Criteria for control :
  • general cognitive level in the standard on the following tests : Mini-Mental State Examination and Fast Front End Efficiency Battery
  • mother tongue : French

排除标准

  • for patients with Alzheimer's disease :
  • game addiction
  • uncorrected visual and hearing disorders
  • other neurological or psychiatric history
  • inability to communicate
  • delusional or psychotic state
  • Exclusion Criteria for control :
  • game addiction
  • psychiatric or neurological disorders
  • anxiety and depression symptomatology

研究组 & 干预措施

Alzheimer's patients (lack of executive functions)

Other

干预措施: cognitive assessment (Diagnostic Test)

control (lack of working memory)

Other

干预措施: working memory (Other)

Alzheimer's patients (lack of episodic memory)

Other

干预措施: cognitive assessment (Diagnostic Test)

control (lack of working memory)

Other

干预措施: cognitive assessment (Diagnostic Test)

Alzheimer's patients (lack of episodic memory)

Other

干预措施: episodic memory (Other)

Alzheimer's patients (lack of executive functions)

Other

干预措施: Inhibition evaluation (Other)

Alzheimer's patients (lack of executive functions)

Other

干预措施: Assessment of mental flexibility (Other)

Alzheimer's patients (lack of executive functions)

Other

干预措施: Evaluation of the update (Other)

control (lack of executive functions)

Other

干预措施: cognitive assessment (Diagnostic Test)

control (lack of executive functions)

Other

干预措施: Inhibition evaluation (Other)

control (lack of executive functions)

Other

干预措施: Assessment of mental flexibility (Other)

control (lack of executive functions)

Other

干预措施: Evaluation of the update (Other)

Alzheimer's patients (lack of working memory)

Other

干预措施: cognitive assessment (Diagnostic Test)

Alzheimer's patients (lack of working memory)

Other

干预措施: working memory (Other)

control (lack of episodic memory)

Other

干预措施: cognitive assessment (Diagnostic Test)

control (lack of episodic memory)

Other

干预措施: episodic memory (Other)

结局指标

主要结局

Score obtained (the number of correct answers) by participants in tasks evaluating decision-making

时间窗: day 14

measured with two decision-making tasks : Iowa Gambling Task and one experimental task

次要结局

  • Scores obtained in tasks evaluating episodic memory(day 14)
  • Scores obtained from the quality of life questionnaire.(day 14)
  • Scores obtained from autonomy questionnaire.(day 14)
  • Score obtained in task evaluating executive functions(day 14)
  • Score obtained in task evaluating working memory(day 14)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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