Cognitive Stimulation in Elderly Individuals at Risk to Develop Dementia (Allena-Mente).

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Effects of Cognitive Stimulation in Elderly Individuals at Risk to Develop Dementia: a Randomized Controlled Trial (Allena-Mente).

Conditions
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Mild Cognitive Impairment, Healthy Subjects With Family History for Dementia

Intervention / Treatment
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* Other: Cognitive stimulation
* Other: Sanitary education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: (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

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive stimulation<br> | Other: Cognitive stimulation<br>* Participants are pooled in small groups (6-8 individuals). Each group participates to ten twice weekly meetings. Each CS session is run by one trained operator. One observer participates to the sessions to guarantee homogeneity between different operators. Exercises are structured with an increasing cognitive complexity and are tailored to the characteristics of the group. Meetings (each lasting about 2 hours) have a common structure: body awakening (10 minutes) cognitive stimulation (1 hour and a half) scheduled as follow: temporospatial orientation attentional abilities one of the following cognitive areas: language, executive functions, verbal and visual memory (encoding, consolidation, retrieval)<br>|
| Active Comparator: Sanitary education<br> | Other: Sanitary education<br>* Participants attend two weekly meetings (for a total of 3 hours) focused on lifestyle education and brain functioning.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term change from Baseline in Mini Mental State Examination (MMSE) | 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. | baseline and up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Mini Mental State Examination at 2-weeks after the intervention | MMSE is a brief test of mental status and cognitive function, commonly used in clinical research to screen global cognitive functioning. | baseline, two-weeks after the intervention | 
| Change from Baseline in Montreal Cognitive Assessment (MoCA) at 2-weeks after the intervention | MoCA is a brief cognitive screening tool with a high sensitivity and specificity for detecting MCI in individuals performing in the normal range on the MMSE (avoiding ceiling effect). | baseline, two-weeks after the intervention | 
| Change from Baseline in Corsi test at 2-weeks after the intervention | Corsi test evaluates visual-spatial short-term memory. We used this test to implement non-verbal memory in our neuropsychological test battery | baseline, two-weeks after the intervention | 
| Change from Baseline in Walking While Talking Dual Task at 2-weeks after the intervention | Walking speed measures the ability to perform a dual action task. Single task: participants walk back and forth along an indicated distance of 5 meters with no pausing. Dual task: participants perform the same movement as in the single task while listing personal names in a loud voice (female names for men and male names for women) The span between time needed to perform the dual and the single task is registered. | baseline, two-weeks after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aging, Mild Cognitive Impairment, Cognitive Stimulation, Elderly, Randomized Controlled Trial