Back to resultsThe Role of Methycobalamin in Early Dementia Patients With Vitamin B12 Deficiency and Hyperhomocysteinaemia.
Primary Purpose
Dementia With Vitamin B12 Deficiency
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Mecobalamin
Sponsored by
About this trial
This is an interventional treatment trial for Dementia With Vitamin B12 Deficiency
Eligibility Criteria
Inclusion: Patients with Dementia Serum B12 < 200 pmol/l Serum Homocysteine level > 11.0 micro mol/L 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
Sites / Locations
- Chinese University of Hong Kong
Outcomes
Primary Outcome Measures
Mattis dementia rating scale
Secondary Outcome Measures
Category fluency test
Delirium rating scale
CNPI
MMSE
Plasma homocysteine
Plasma isoprostane
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00165711
Brief Title
The Role of Methycobalamin in Early Dementia Patients With Vitamin B12 Deficiency and Hyperhomocysteinaemia.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2005
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Co., Ltd.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia With Vitamin B12 Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Mecobalamin
Primary Outcome Measure Information:
Title
Mattis dementia rating scale
Secondary Outcome Measure Information:
Title
Category fluency test
Title
Delirium rating scale
Title
CNPI
Title
MMSE
Title
Plasma homocysteine
Title
Plasma isoprostane
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Eligibility Criteria
Inclusion:
Patients with Dementia
Serum B12 < 200 pmol/l
Serum Homocysteine level > 11.0 micro mol/L
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romeo Chu
Organizational Affiliation
Eisai Asia Regional Services Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Chinese University of Hong Kong
City
Hong Kong
State/Province
Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Role of Methycobalamin in Early Dementia Patients With Vitamin B12 Deficiency and Hyperhomocysteinaemia.
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