Dementia With Vitamin B12 Deficiency
Conditions
Brief summary
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.
Interventions
DRUGMecobalamin
Sponsors
Eisai Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mattis dementia rating scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Delirium rating scale | — |
| CNPI | — |
| Category fluency test | — |
| Plasma homocysteine | — |
| Plasma isoprostane | — |
| MMSE | — |
Countries
China
Outcome results
None listed