NCT01793493

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Fondazione Golgi Cenci · Academic / Other
• Sex: All
• Age: 70 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Mild Cognitive Impairment
• Healthy Subjects With Family History for Dementia

Interventions

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

Timeline

• Start date: 2011-03-01
• Primary completion: 2015-03-01
• Completion: 2015-06-01
• First posted: 2013-02-15
• Last updated: 2023-09-13

Locations

1 site across 1 country: Italy