The Role of Methylcobalamin in Early Dementia Patients With Vitamin B12 Deficiency and Hyperhomocysteinaemia ?

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00164983
• Date of registration: 12/09/2005
• Primary sponsor: Chinese University of Hong Kong
• Public title: The Role of Methylcobalamin in Early Dementia Patients With Vitamin B12 Deficiency and Hyperhomocysteinaemia ?
• Scientific title: The Role of Methylcobalamin in Early Dementia Patients With Vitamin B12
• Date of first enrolment: October 2003
• Target sample size: 29
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00164983
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

China

Contacts

• Name: Timothy CY Kwok, MD
• Affiliation: Chinese University of Hong Kong

Key inclusion & exclusion criteria

Inclusion Criteria:

- serum vitamin B12 level < 200 pmol/l

Exclusion Criteria:

- significant communication problems – deafness, dysarthria, dysphasia etc.

- unstable diabetes mellitus or hypertension

- alcohol abuse

- significant co-existing diseases which may affect cognitive, e.g. congestive cardiac
failure, respiratory failure, Parkinson’s disease etc.

- folate < 10 nmol/l

- haemoglobin concentration <10 g/dl

- abnormal thyroid function test or VDRL



Age minimum: 60 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Dementia

Intervention(s)

Drug: methylcobal

Primary Outcome(s)

Dementia at 4 motnhs

Secondary Outcome(s)

plasma homocysteine at 4 months

plasma isoprostane at 4 months

Secondary ID(s)

OL-methylcobal

Source(s) of Monetary Support

Please refer to primary and secondary sponsors