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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: September 14, 2005
Last Update Posted: December 12, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eisai Inc.
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.

Condition Intervention Phase
Dementia With Vitamin B12 Deficiency Drug: Mecobalamin Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Mattis dementia rating scale

Secondary Outcome Measures:
  • Category fluency test
  • Delirium rating scale
  • CNPI
  • MMSE
  • Plasma homocysteine
  • Plasma isoprostane

Study Start Date: March 2003

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All


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


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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165711

China, Hong Kong
Chinese University of Hong Kong
Hong Kong, Hong Kong, China
Sponsors and Collaborators
Eisai Co., Ltd.
Study Director: Romeo Chu Eisai Asia Regional Services Ltd.
  More Information

ClinicalTrials.gov Identifier: NCT00165711     History of Changes
Obsolete Identifiers: NCT00164983
Other Study ID Numbers: AS-006 (MBL-HKG-05-01)
First Submitted: September 12, 2005
First Posted: September 14, 2005
Last Update Posted: December 12, 2005
Last Verified: December 2005

Additional relevant MeSH terms:
Vitamin B 12 Deficiency
Vitamin B Deficiency
Deficiency Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Nutrition Disorders