Completed

NCT Number: NCT00165711

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

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.

Completed

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Key information

Conditions

Dementia With Vitamin B12 Deficiency

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chinese University of Hong Kong

Hong Kong, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mecobalamin

Drug

Primary outcomes

Mattis dementia rating scale

Secondary outcomes

Category fluency test
Delirium rating scale
CNPI
MMSE
Plasma homocysteine
Plasma isoprostane

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Important dates

Study start: 2003
First posted: Sep 14, 2005
Registry last updated: Feb 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.