Cognitive Training in Elders Without Dementia Using UMAM Method. Genetic, Brain Volume and Cognitive Reserve Predictors: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 199
- 试验地点
- 2
- 主要终点
- Change in visual memory
研究概览
简要总结
The study is oriented to analyze the effectiveness of a cognitive training method (UMAM) on cognitive functions, subjective memory and mood state in elderly people without dementia. On the other hand, the study aims to examine whether variables such as cognitive reserve (e.g. educational level), APOE genotype and intracranial volume are related to increased benefit after the intervention. The researchers hope to find that greater cognitive reserve, not having the APOE allele ε4, and a greater volume of memory-related brain areas, are associated with better outcomes after the cognitive intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Being over 60 years old.
- •Having a global cognitive performance > 23 in the Mini Mental State Examination Test.
- •Having no history of neurological or serious psychiatric disorders (severe psycho-affective disorders and psychosis or other psychiatric disorders like alcoholism).
排除标准
- •Chronic use of anxiolytics.
- •Chronic use of neuroleptics.
- •Chronic use of anticonvulsants.
- •Having hearing or vision impairments that would preclude testing.
- •Magnetic Resonance Imaging (MRI) contraindications.
结局指标
主要结局
Change in visual memory
时间窗: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in visual memory, assessed with the Rey memory test (form B). The score ranges from 0 to 22 points. Higher scores indicate a better outcome.
Change in general cognition
时间窗: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in general cognition, assessed with the Mini Mental State Examination Test (MMSE) and the 7 Minutes Test (7M).The score ranges from 0 to 30 points (MMSE) and from 0 to 89 points (7M). In both cases, the higher scores indicate a better outcome.
Change in attentional amplitude
时间窗: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in attentional amplitude, assessed with the Direct Digit Test of the Wechsler Memory Scale-III. The score ranges from 0 to 16 points. Higher scores indicate a better outcome.
Change in verbal fluency (language)
时间窗: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in phonologic and semantic verbal fluency, assessed with the Phonological Verbal Fluency Test and the Semantic Fluency Test respectively. The score goes from zero onwards (there is no upper limit). Higher scores indicate a better outcome.
Change in mood
时间窗: This variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in mood, assessed with the Geriatric Depression Scale. The score ranges from 0 to 15 points. Higher scores indicate a worse outcome.
The Brain Volume as a predictor of change.
时间窗: The Brain Volume was assessed in the pre-intervention assessment.
The Brain Volume (total gray volume, left hippocampus, right hippocampus and total intracranial volume) was assessed by magnetic resonance imaging. Unit of measure: mm3.
Change in daily memory
时间窗: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in daily memory, assessed with the Rivermead Behavioral Memory Test. The score ranges from 0 to 24 points. Higher scores indicate a better outcome.
The Cognitive Reserve as a predictor of change.
时间窗: Cognitive Reserve was assessed in the pre-intervention assessment.
The Cognitive Reserve was assessed with Rami Test. The score ranges from 0 to 25 points.
Change in verbal memory
时间窗: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in verbal memory, assessed with the Word List Test of the Wechsler Memory Scale-III. The score ranges from 0 to 48 points. Higher scores indicate a better outcome.
Change in logical memory
时间窗: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in immediate and delayed logical memory, assessed with the Logical Memory Test (immediate and delayed units) of the Wechsler Memory Scale-III. The score ranges from 0 to 75 points (immediate units) and from 0 to 50 (delayed units). Higher scores indicate a better outcome.
Change in attentional control
时间窗: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in attentional control, assessed with the Inverse Digit Test of the Wechsler Memory Scale-III. The score ranges from 0 to 14 points. Higher scores indicate a better outcome.
Change in attention and processing speed
时间窗: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in attention, assessed with the Trail Making Test, form A. The score ranges from 0 to 200 points. Higher scores indicate a worse outcome.
Change in subjective memory
时间窗: This variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in Subjective Memory, assessed with the Memory Failures of Everyday Questionnaire.The score ranges from 0 to 56 points. Higher scores indicate a worse outcome.
The Genetic Profile as a predictor of change.
时间窗: The Genetic Profile was assessed in the pre-intervention assessment.
The Genetic Profile was obtained by genetic analysis employing a blood test. APOE gene has been coded as 1 (meaning no ε4 allele), or 0 (for at least one ε4 allele).
Change in alternating attention and planning
时间窗: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in alternating attention and planning, assessed with the Trail Making Test, form B. The score ranges from 0 to 400 points. Higher scores indicate a worse outcome.
Change in naming ability (language)
时间窗: This cognitive variable was assessed before and after the intervention. The interval between the pre and post-intervention assessment was 6 months.
The measure of the post-intervention change in naming ability, assessed with the Boston Naming Test. The score ranges from 0 to 60 points. Higher scores indicate a better outcome.
次要结局
未报告次要终点