The Role of Methycobalamin in Early Dementia Patients With Vitamin B12 Deficiency and Hyperhomocysteinaemia.

Eisai

Status and phase: Completed; Phase 4

Conditions: Dementia With Vitamin B12 Deficiency

Treatments: Drug: Mecobalamin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00165711

AS-006 (MBL-HKG-05-01)

Details and patient eligibility

About

Patients who fit the inclusion criteria are admitted into the study. They are given 3 IV injection of MBL in the first week and one tablet three times a day for 16 weeks.

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

• Patients with Dementia
• Serum B12 < 200 pmol/l
• Serum Homocysteine level > 11.0 micro mol/L

Exclusion:

Significant communication problems

• deafness, dysarthria, dysphasia etc.
• unstable DM or hypertension
• alcohol abuse
• co-existing diseases which may affect cognition e.g. cognitive cardiac failure, respiratory failure
• folate < 10 g/dl
• haemoglobin concentration < 10g/d
• abnormal thyroid function test or VDRL

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)