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

NCT ID: NCT00165711

Last Updated: 2019-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dementia With Vitamin B12 Deficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Mecobalamin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Romeo Chu

Role: STUDY_DIRECTOR

Eisai Asia Regional Services Ltd.

Locations

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Chinese University of Hong Kong

Hong Kong, Hong Kong, China

Site Status

Countries

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China

Other Identifiers

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AS-006 (MBL-HKG-05-01)

Identifier Type: -

Identifier Source: org_study_id

NCT00164983

Identifier Type: -

Identifier Source: nct_alias

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