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

This study has been completed.
Information provided by:
Eisai Inc. Identifier:
First received: September 12, 2005
Last updated: December 8, 2005
Last verified: December 2005
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

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
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Please refer to this study by its identifier: 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 Identifier: NCT00165711     History of Changes
Obsolete Identifiers: NCT00164983
Other Study ID Numbers: AS-006 (MBL-HKG-05-01)
Study First Received: September 12, 2005
Last Updated: December 8, 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 processed this record on September 21, 2017