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

Mild Cognitive Impairment Clinical Trial

— Allena-Mente  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01793493
• Other study ID #: 02
• Status: Completed
• Phase: N/A
• Start date: March 2011
• Est. completion date: June 2015

Study information

• Verified date: September 2023
• Source: Fondazione Golgi Cenci
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: June 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Dementia
• Healthy Subjects With Family History for Dementia
• Mild Cognitive Impairment

Intervention

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

Locations

Country	Name	City	State
Italy	Golgi Cenci Foundation	Abbiategrasso	Milan

Sponsors (5)

Lead Sponsor	Collaborator
Fondazione Golgi Cenci	Alzheimer Federation Italy, Camillo Golgi Geriatric Institute, Mario Negri Institute for Pharmacological Research, University of Pavia

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Polito L, Abbondanza S, Vaccaro R, Valle E, Davin A, Degrate A, Villani S, Guaita A. Cognitive stimulation in cognitively impaired individuals and cognitively healthy individuals with a family history of dementia: short-term results from the "Allena-Mente" randomized controlled trial. Int J Geriatr Psychiatry. 2015 Jun;30(6):631-8. doi: 10.1002/gps.4194. Epub 2014 Sep 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline and up to 4 years
Secondary	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.	baseline, two-weeks after the intervention
Secondary	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).	baseline, two-weeks after the intervention
Secondary	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	baseline, two-weeks after the intervention
Secondary	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.	baseline, two-weeks after the intervention

External Links

•   official web site of the organization responsible for the study
•   official website of the caregivers organization, partner in the sponsorship of the research