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

F

Fondazione Golgi Cenci

Status

Completed

Conditions

Mild Cognitive Impairment
Healthy Subjects With Family History for Dementia

Treatments

Other: Sanitary education
Other: Cognitive stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT01793493
02

Details and patient eligibility

About

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).

Full 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.

Enrollment

121 patients

Sex

All

Ages

70 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

121 participants in 2 patient groups

Cognitive stimulation
Experimental group
Treatment:
Other: Cognitive stimulation
Sanitary education
Active Comparator group
Treatment:
Other: Sanitary education

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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