An interventional study of Cognitive stimulation and Sanitary education in Mild Cognitive Impairment and Healthy Subjects With Family History for Dementia, sponsored by Fondazione Golgi Cenci. Completed at 1 site in Italy. Open to participants aged 70 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-09-13.
Sponsored by Fondazione Golgi Cenci · Not applicable, Interventional, and Treatment
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).
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.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's enrollment of 121 is above the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →Fondazione Golgi Cenci is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Cognitive stimulation
Other: Sanitary education
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)
Participants attend two weekly meetings (for a total of 3 hours) focused on lifestyle education and brain functioning.
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.
Time frame: baseline and up to 4 years
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.
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: baseline, two-weeks after the intervention
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Fondazione Golgi Cenci