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

Fondazione Golgi Cenci

Status: Completed

Conditions: Mild Cognitive Impairment; Healthy Subjects With Family History for Dementia

Treatments: Other: Sanitary education; Other: Cognitive stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01793493

02

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 121 patients

Sex: All

Ages: 70 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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121 participants in 2 patient groups

Cognitive stimulation

Experimental group

Treatment:

Other: Cognitive stimulation

Sanitary education

Active Comparator group

Treatment:

Other: Sanitary education