Effects of Cognitive Stimulation in Elderly Individuals at Risk to Develop Dementia: a Randomized Controlled Trial (Allena-Mente).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Long-term change from Baseline in Mini Mental State Examination (MMSE)
研究概览
简要总结
The Allena-Mente study is a randomized, controlled, single-blind trial assessing the efficacy of cognitive stimulation (CS) compared to an active control group, participating to sanitary education lessons (AC). This non-pharmacological intervention is delivered to Mild Cognitive Impairment (MCI) and cognitively healthy individuals with first-degree relative with dementia (NDFAM).
详细描述
The experimental protocol was set up with a pilot study on healthy elderly individuals. Data from this pilot study will be excluded from the statistical analysis.
Sample size: a priori power analysis was performed to evaluate the sample size required for the study. MCI and NDFAM were considered separately for sample size calculation. For power calculation a two-tailed test was used and a significance level (α) and test power (1-β) were set at 0.05 and 0.8/0.9, respectively.
Randomization: The individuals belonging to MCI and NDFAM subgroup were randomly assigned to CS or AC group. The randomization was performed by a statistician blind to participants characteristics using the Random Allocation Software. Allocation ratio was set at 1:1, stratification was performed for birth cohort (≤1937 and ≥1938), education level (years of education ≤5 years and >5 years).
Participants provided written informed consent before study participation.
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
- 70 Years 至 75 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive diagnosis for mild cognitive impairment (MCI) according to Petersen's criteria;
- •Cognitively healthy elderly individuals, having at least one first-degree relative affected by dementia (Alzheimer's Disease, pre-senile and senile dementia, vascular dementia) (NDFAM).
排除标准
- •(Major physical illness) Compromission of motor performance of lower and upper limbs
- •Medical conditions leading to clinical instability;
- •Therapies that reduce cognitive and communicative abilities and consciousness;
- •Perceptual disorders (sight, hearing)
- •Language disorders
- •Education level lower than 3 years
- •Psychiatric and behavioral disorders
- •Addiction to drugs or alcohol
结局指标
主要结局
Long-term change from Baseline in Mini Mental State Examination (MMSE)
时间窗: baseline and up to 4 years
Mini Mental State examination (MMSE) is a brief test of mental status and cognitive function, commonly used in clinical research to screen global cognitive functioning.
次要结局
- Change from Baseline in Mini Mental State Examination at 2-weeks after the intervention(baseline, two-weeks after the intervention)
- Change from Baseline in Corsi test at 2-weeks after the intervention(baseline, two-weeks after the intervention)
- Change from Baseline in Montreal Cognitive Assessment (MoCA) at 2-weeks after the intervention(baseline, two-weeks after the intervention)
- Change from Baseline in Walking While Talking Dual Task at 2-weeks after the intervention(baseline, two-weeks after the intervention)
研究者
Antonio Guaita, MD
MD
Fondazione Golgi Cenci