Clinical trial NCT01793493: Cognitive Stimulation in Elderly Individuals at Risk to Develop Dementia (Allena-Mente).
Official title: Effects of Cognitive Stimulation in Elderly Individuals at Risk to Develop Dementia: a Randomized Controlled Trial (Allena-Mente).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Healthy Subjects With Family History for Dementia
Keywords: Mild Cognitive Impairment
Cognitive Stimulation
Aging
Elderly
Randomized Controlled Trial
Lead sponsor: Fondazione Golgi Cenci
Sponsor class: OTHER
Collaborators: name: Alzheimer Federation Italy
name: Camillo Golgi Geriatric Institute
name: University of Pavia
name: Mario Negri Institute for Pharmacological Research
First posted: 2013-02-15
Enrollment: 121
Sex: ALL
Minimum age (years): 70
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Long-term change from Baseline in Mini Mental State Examination (MMSE)
timeFrame: baseline and up to 4 years
Secondary outcomes:
measure: Change from Baseline in Mini Mental State Examination at 2-weeks after the intervention
timeFrame: baseline, two-weeks after the intervention
measure: Change from Baseline in Montreal Cognitive Assessment (MoCA) at 2-weeks after the intervention
timeFrame: baseline, two-weeks after the intervention
measure: Change from Baseline in Corsi test at 2-weeks after the intervention
timeFrame: baseline, two-weeks after the intervention
measure: Change from Baseline in Walking While Talking Dual Task at 2-weeks after the intervention
timeFrame: baseline, two-weeks after the intervention
Other outcomes:
Locations:
city: Abbiategrasso
country: Italy
facility: Golgi Cenci Foundation
state: Milan
Study officials:
affiliation: GolgiCenci Foundation
name: Antonio Guaita, MD
role: STUDY_DIRECTOR
References:
citation: 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.