Ignite Creation Date:
2024-05-06 @ 1:21 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01793493
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2013-02-13
Brief Title:
Cognitive Stimulation in Elderly Individuals at Risk to Develop Dementia Allena-Mente
Sponsor:
Fondazione Golgi Cenci
Organization:
Fondazione Golgi Cenci
Study Overview
Official Title:
Effects of Cognitive Stimulation in Elderly Individuals at Risk to Develop Dementia a Randomized Controlled Trial Allena-Mente
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Allena-Mente
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 005 and 0809 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 11 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
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 005 and 0809 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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None