Older People and Enhanced Neurocognitive function study
- Conditions
- erve and cognitive functionNervous System DiseasesCognitive function
- Registration Number
- ISRCTN54195799
- Lead Sponsor
- ondon School of Hygiene and Tropical Medicine (LSHTM) (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
1. Healthy volunteers
2. Aged 75 years and over, either sex
3. Defined low B12 status (greater than 107 pmol/l and less than 210 pmol/l)
4. No previous history of diabetes or dementia
1. Pre-existing type I or type II diabetes at baseline
2. Pre-existing dementia at baseline
3. Currently consuming vitamin B12 on a daily basis
4. Mini-Mental State Examination (MMSE) score less than 24 at baseline screen
5. Very low B12 (below 107 pmol/l - Beckman Coulter assay)
6. B12 levels above 210 pmol/l
7. Anaemic
8. History of epilepsy
9. Those with implanted metallic devices such as a pacemaker
10. Alcoholics
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Amplitude of tibial motor evoked responses and tibial nerve conduction velocity, measured at 12 months.
- Secondary Outcome Measures
Name Time Method 1. Cognitive function: immediate recall, prospective memory, letter search/cancellation, verbal fluency, symbol digit modalities, simple and choice reaction time<br>2. Timed up and go<br>3. Psychological health (mood) using the 30-item General Health Questionnaire (GHQ-30)<br>4. Height and weight <br>5. History of myocardial infarction (MI) and stroke (reported hospitalisation) <br><br>All outcomes measured at 12 months.