NCT00165711

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

February 19, 2019

Status Verified

December 1, 2005

First QC Date

September 12, 2005

Last Update Submit

February 18, 2019

Conditions

Dementia With Vitamin B12 Deficiency

Outcome Measures

Primary Outcomes (1)

  • Mattis dementia rating scale

Secondary Outcomes (6)

  • Category fluency test

  • Delirium rating scale

  • CNPI

  • MMSE

  • Plasma homocysteine

  • +1 more secondary outcomes

Interventions

MecobalaminDRUG

Eligibility Criteria

Age60 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese University of Hong Kong

Hong Kong, Hong Kong, China

Location

MeSH Terms

Interventions

mecobalamin

Study Officials

  • Romeo Chu

    Eisai Asia Regional Services Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 14, 2005

Study Start

March 1, 2003

Last Updated

February 19, 2019

Record last verified: 2005-12

Locations

CN(1)