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

Fondazione Golgi Cenci121 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

121

Conditions

Mild Cognitive Impairment Healthy Subjects With Family History for Dementia

Interventions

Cognitive stimulationOTHER

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)

Sanitary educationOTHER

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

Eligibility

Sex: ALLMin age: 70 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Golgi Cenci Foundation

Abbiategrasso, Milan, Italy

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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