|
| NB: The information displayed below does not replace the protocol. The latest protocol version should always be consulted before making clinical decisions. |
|
VITACOG
|
|
Homocysteine and B Vitamins in Cognitive Impairment
|
|
|
Topic
|
|
Dementias and Neurodegenerative Diseases
|
|
Portfolio Eligibility
|
|
Funded by UKCRC partner
|
|
|
ISRCTN
|
94410159
|
|
EudraCT
|
2004-001527-38
|
|
MREC N° |
04/Q1604/100
|
|
UKCRN ID |
2521
|
|
WHO ID
|
|
|
|
|
Study Type |
Interventional
|
|
Design Type |
Treatment
|
|
Disease(s) |
Dementia
|
|
Phase |
IV
|
|
|
Current Status
| Closed - follow-up complete |
| Closure Date | 30/11/2006 |
|
Sample Size
| 300 |
|
|
Geographical Scope
| Single Centre |
|
Lead Country
| England |
|
|
Main Inclusion Criteria
|
Inclusion Criteria
1. 70 years or older. Subjects should have had their 70th birthday by the date of Visit 1.
2. MCI (according to TICS-M score)
3. No dementia diagnosis.
4. Have an informant who knows them well enough to complete the IQCODE and the informant CDR and can be present at visits 1 and 2.
5. Has not taken part in another drug study in the past 3 months and is not enrolled concurrently in another drug study (unless with agreement by PI of both studies).
6. On questioning, has adequate hearing and vision to complete study assessments.**
|
|
|
Main Exclusion Criteria
|
Exclusion Criteria
1. Have a diagnosis of dementia
2. Are on treatment with drugs for dementia
3. Have a diagnosis of active cancer (past history of cancer, inactive or not on treatment to be discussed with PI)
4. Have had a major stroke within the last 3 months
5. Have a diagnosis of pernicious anaemia
6. Have had some of the small intestine removed at operation
7. Are taking anti-cancer or epileptic drugs or methotrexate
8. Are on treatment for Vitamin B deficiency (e.g., B12 Injections)
9. Medication exclusion: subjects taking one or more of the following:
Pyridoxine (vitamin B6) OVER 3mg per day
Folic acid OVER 300 micrograms per day
Cobalamin (vitamin B12) OVER 1.5 micrograms per day by mouth
10. Have any other medical condition(s) that the PI decides are unacceptable for study inclusion.
|
|
|
Chief Investigator(s)
|
| Prof A David Smith |
|
|
Further details, please contact
|
Miss Pippa Whitbread
Radcliffe Infirmary
OPTIMA
Woodstock Road
Oxford
Oxfordshire
OX2 6HE
UNITED KINGDOM
Tel: 01865-617183
pippa.whitbread@dpag.ox.ac.uk
|
|
|
Funder(s) |
Medical Research Council
Henry Smith Foundation
Charles Wolfson Charitable Trust
|
|
Sponsor(s) |
University of Oxford
|
|
|
|