Mild Cognitive Impairment
Conditions
Brief summary
The purpose of this study is to determine whether an omega-3 fatty acid supplementation is effective in the prevention of progressive cognitive decline in elderly people aged 75 years or older.
Detailed description
Participants are residents at three nursing homes in Pamplona (Spain). We assumed that 20% of elderly people have a cognitive decline and we estimated a 5% of cognitive decline in the intervention group. Sample size estimated was 85 participants for each arm, assuming two groups with an alpha of 0.05, 80% power and accounting for 10% of participants lost to follow-up. Repeated measures ANOVA, Cox regression and multiple linear regression analysis will be used for the statistical analysis of data.
Interventions
DIETARY_SUPPLEMENTOmega-3 fatty acid supplementation
Gelatine capsule, 1 at each meals (3 per day) during one year
Sponsors
Clinica Universidad de Navarra, Universidad de Navarra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Elderly people aged 75 years or older * Global Deterioration Scale \< 4 * Capacity to complete the tests
Exclusion criteria
* Neurological, physical or psychiatry conditions, obtained from the medical history, that may have an influence on the cognitive function. * Dementia * History of epilepsy, convulsions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mini Mental State Examination | Six months / one year | MMSE is a brief questionnaire test that is used to screen for cognitive impairment. A validated test in Spanish will be used: Lobo A. Saza P. Marcos G, Díaz J, De la Cámara C, Ventura T et al: Revalidación y normalización del Mini-Examen Cogniscitivo (primera versión en castellano del Mini-Mental Status Examination) en la población general geriátrica. Med Clin (Barc) 1999;112:767-774. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Portable Mental Status Questionnaire (SPMSQ) | One year | A questionnaire for the assessment of organic brain deficit in elderly patients (Pfeiffer E. A short portable mental status questionnaire for the assessment of organic brain deficit in elderly patients. J Am Geriatr Soc. 1975;23:433-41) |
| Verbal fluency test | One year | Category verbal fluency test. Rosen W.: Verbal fluency in aging and dementia. J. Clin Neuropsychol 1980;2: 135-146. |
| Clock-drawing test | One year | A cognitive test that covers a wide range of cognitive function. Battersby, W.S., Bender, M.B., Pollack, M. y Kahn, R.L. Unilateral spatial agnosia (inattention) in patients with cortical lesions. Brain 1956; 79: 68-93. |
Countries
Spain
Outcome results
None listed