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

Dementia With Vitamin B12 Deficiency Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00165711
• Other study ID #: AS-006 (MBL-HKG-05-01)
• Status: Completed
• Phase: Phase 4
• Start date: March 2003

Study information

• Verified date: December 2005
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00164983

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dementia
• Dementia With Vitamin B12 Deficiency
• Vitamin B 12 Deficiency

Intervention

Drug:
• Mecobalamin

Locations

Country	Name	City	State
China	Chinese University of Hong Kong	Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mattis dementia rating scale
Secondary	Category fluency test
Secondary	Delirium rating scale
Secondary	CNPI
Secondary	MMSE
Secondary	Plasma homocysteine
Secondary	Plasma isoprostane