Dementia With Vitamin B12 DeficiencyPhase 4NCT00165711
The Role of Methycobalamin in Early Dementia Patients With Vitamin B12 Deficiency and Hyperhomocysteinaemia.
A Phase 4 study testing Mecobalamin in people with Dementia With Vitamin B12 Deficiency, run by Eisai Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia With Vitamin B12 Deficiency
- What is being tested?
- Mecobalamin
- How many people
- Not given
- Where
- 1 siteChina
- Study dates
- Mar 2003to not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Patients with Dementia
- Serum B12 < 200 pmol/l
- Serum Homocysteine level > 11.0 micro mol/L
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Dementia With Vitamin B12 Deficiency
- Being tested
- Mecobalamin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MecobalaminDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Mattis dementia rating scale
Secondary outcomes (6)
Category fluency test
Delirium rating scale
CNPI
MMSE
Plasma homocysteine
Plasma isoprostane
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia With Vitamin B12 DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Romeo Chu, Study director, Eisai Asia Regional Services Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00165711
- Sponsor's protocol ID
- AS-006 (MBL-HKG-05-01)
- Status last verified
- Dec 2005
- First submitted
- 12 Sep 2005
- Last updated
- 19 Feb 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Methycobalamin in Early Dementia Patients With Vitamin B12 Deficiency and Hyperhomocysteinaemia.
- ClinicalTrials.gov ID
- NCT00165711
- Acronym / sponsor ID
- AS-006 (MBL-HKG-05-01)
- Conditions
- Dementia With Vitamin B12 Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2003
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with Dementia
- Serum B12 < 200 pmol/l
- Serum Homocysteine level > 11.0 micro mol/L
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mecobalamin | Drug | – |
Primary outcome
Mattis dementia rating scale
6 secondary outcomes
Category fluency test
Delirium rating scale
CNPI
MMSE
Plasma homocysteine
Plasma isoprostane
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
Related trials for Dementia With Vitamin B12 Deficiency
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romeo Chu study director
Eisai Asia Regional Services Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mecobalamin in people with Dementia With Vitamin B12 Deficiency, run by Eisai Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mattis dementia rating scale. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2019.