The Role of Methycobalamin in Early Dementia Patients With Vitamin B12 Deficiency and Hyperhomocysteinaemia.
Sponsor
Eisai Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT00165711
Collaborator
(none)
1
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date
:
Mar 1, 2003
Outcome Measures
Primary Outcome Measures
- Mattis dementia rating scale []
Secondary Outcome Measures
- Category fluency test []
- Delirium rating scale []
- CNPI []
- MMSE []
- Plasma homocysteine []
- Plasma isoprostane []
Eligibility Criteria
Criteria
Ages Eligible for Study:
60 Years
and Older
Sexes Eligible for Study:
All
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chinese University of Hong Kong | Hong Kong | Hong Kong | China |
Sponsors and Collaborators
- Eisai Co., Ltd.
Investigators
- Study Director: Romeo Chu, Eisai Asia Regional Services Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Eisai Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00165711
Other Study ID Numbers:
- AS-006 (MBL-HKG-05-01)
- NCT00164983
First Posted:
Sep 14, 2005
Last Update Posted:
Feb 19, 2019
Last Verified:
Dec 1, 2005