ClinicalTrials.gg
CompletedNCT00165711Updated Feb 19, 2019

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

A Phase 4 interventional study of Mecobalamin in Dementia With Vitamin B12 Deficiency, sponsored by Eisai Co., Ltd.. Completed at 1 site in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2019-02-19.

Sponsored by Eisai Co., Ltd. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Allocation
Non-randomized
Ages
60 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Dementia With Vitamin B12 Deficiency
03

In context

Lead sponsor

Eisai Co., Ltd. is the lead sponsor of 152 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)

Interventions

06

What researchers measure

Primary outcomes

  1. Mattis dementia rating scale

Secondary outcomes

  1. Category fluency test

  2. Delirium rating scale

  3. CNPI

  4. MMSE

  5. Plasma homocysteine

  6. Plasma isoprostane

07

Study locations

1 site
  • Chinese University of Hong Kong
    Hong Kong, Hong Kong, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00165711
Lead sponsor
Eisai Co., Ltd.
Responsible party
Sponsor
First posted
Sep 14, 2005
Start date
Mar 2003
Last update
Feb 19, 2019

Study contacts

Romeo Chu
study director · Eisai Asia Regional Services Ltd.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2005. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Mecobalamin

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