Cognitive Stimulation in Elderly Individuals at Risk to Develop Dementia (Allena-Mente). (Allena-Mente)
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|ClinicalTrials.gov Identifier: NCT01793493|
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : August 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment Healthy Subjects With Family History for Dementia||Other: Cognitive stimulation Other: Sanitary education||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||121 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effects of Cognitive Stimulation in Elderly Individuals at Risk to Develop Dementia: a Randomized Controlled Trial (Allena-Mente).|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||June 2015|
|Experimental: Cognitive stimulation||
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:
|Active Comparator: Sanitary education||
Other: Sanitary education
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) [ Time Frame: baseline and up to 4 years ]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.
- Change from Baseline in Mini Mental State Examination at 2-weeks after the intervention [ Time Frame: baseline, two-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.
- Change from Baseline in Montreal Cognitive Assessment (MoCA) at 2-weeks after the intervention [ Time Frame: baseline, two-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).
- Change from Baseline in Corsi test at 2-weeks after the intervention [ Time Frame: baseline, two-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
- Change from Baseline in Walking While Talking Dual Task at 2-weeks after the intervention [ Time Frame: baseline, two-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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793493
|Golgi Cenci Foundation|
|Abbiategrasso, Milan, Italy, 20081|
|Study Director:||Antonio Guaita, MD||GolgiCenci Foundation|