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

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.
ClinicalTrials.gov Identifier: NCT00165711
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : December 12, 2005
Information provided by:
Eisai Inc.

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.

Condition or disease Intervention/treatment Phase
Dementia With Vitamin B12 Deficiency Drug: Mecobalamin Phase 4

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: B Vitamins Dementia
Drug Information available for: Mecobalamin
U.S. FDA Resources

Primary Outcome Measures :
  1. Mattis dementia rating scale

Secondary Outcome Measures :
  1. Category fluency test
  2. Delirium rating scale
  3. CNPI
  4. MMSE
  5. Plasma homocysteine
  6. Plasma isoprostane

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

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.

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

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