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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2015-06-30

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).

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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.

Conditions

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Mild Cognitive Impairment Healthy Subjects With Family History for Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cognitive stimulation

Group Type EXPERIMENTAL

Cognitive stimulation

Intervention Type OTHER

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)

Sanitary education

Group Type ACTIVE_COMPARATOR

Sanitary education

Intervention Type OTHER

Participants attend two weekly meetings (for a total of 3 hours) focused on lifestyle education and brain functioning.

Interventions

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Cognitive stimulation

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)

Intervention Type OTHER

Sanitary education

Participants attend two weekly meetings (for a total of 3 hours) focused on lifestyle education and brain functioning.

Intervention Type OTHER

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

Minimum Eligible Age

70 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No