The Role of Methycobalamin in Early Dementia Patients Wit... | NCT00165711

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

NCT00165711

Sponsor

Eisai Co., Ltd.

Status

Completed

Last Update Posted

Feb 19, 2019Actual

Enrollment

Not provided

Phase

Phase 4

Conditions

Dementia With Vitamin B12 Deficiency

Interventions

Mecobalamin

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2003

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 14, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2019

Last Update Posted Date

Feb 19, 2019Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Mecobalamin	Drug

Measure	Description	Time Frame
Mattis dementia rating scale

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Romeo Chu	Eisai Asia Regional Services Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chinese University of Hong Kong		Hong Kong	Hong Kong		China

Intervention Browse Module

MeSH Terms

ID	Term
C019476	mecobalamin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided