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Older People and Enhanced Neurocognitive function study

Not Applicable
Completed
Conditions
erve and cognitive function
Nervous System Diseases
Cognitive 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
Inclusion Criteria

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

Exclusion Criteria

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
NameTimeMethod
Amplitude of tibial motor evoked responses and tibial nerve conduction velocity, measured at 12 months.
Secondary Outcome Measures
NameTimeMethod
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.
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