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Completed

NCT Number: NCT01793493

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

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).

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Healthy Subjects With Family History for Dementia Mental Disorders Neurocognitive Disorders

Age range

70 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Golgi Cenci Foundation

Abbiategrasso, Milan, 20081, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cognitive stimulation

Other

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 education

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

Fondazione Golgi Cenci

Other

Collaborators

  • Alzheimer Federation Italy
  • Camillo Golgi Geriatric Institute
  • Mario Negri Institute for Pharmacological Research
  • University of Pavia

Registry information

Official study title

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

Acronym: Allena-Mente

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Feb 15, 2013
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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