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

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment; Healthy Subjects With Family History for Dementia
• Interventions: Other: Cognitive stimulation; Other: Sanitary education

• Registration Number: NCT01793493
• Lead Sponsor: Fondazione Golgi Cenci

Brief 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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2013-02-13
• Study First Submitted QC: 2013-02-14
• Study First Posted: 2013-02-15
• Primary Completion: 2015-03
• Study Completion: 2015-06
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive stimulation	Cognitive stimulation	-
Sanitary education	Sanitary education	-

Primary Outcome Measures

Name	Time	Method
Long-term change from Baseline in Mini Mental State Examination (MMSE)	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.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Mini Mental State Examination at 2-weeks after the intervention	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 Corsi test at 2-weeks after the intervention	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 Montreal Cognitive Assessment (MoCA) at 2-weeks after the intervention	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 Walking While Talking Dual Task at 2-weeks after the intervention	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.

Trial Locations

Locations (1)

Golgi Cenci Foundation; 🇮🇹 Abbiategrasso, Milan, Italy