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

September 11, 2023 updated by: Antonio Guaita, MD, Fondazione Golgi Cenci

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milan
      • Abbiategrasso, Milan, Italy, 20081
        • Golgi Cenci Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 75 years (Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:

  • 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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and up to 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, two-weeks after the intervention
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).
baseline, two-weeks after the intervention
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
baseline, two-weeks after the intervention
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.
baseline, two-weeks after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Golgi Cenci

Collaborators

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

Investigators

  • Study Director: Antonio Guaita, MD, GolgiCenci Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

February 13, 2013

First Submitted That Met QC Criteria

February 14, 2013

First Posted (Estimated)

February 15, 2013

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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