Alzheimer DiseasePhase 4NCT00216515
The Efficacy of Galantamine on the Attention and the Frontal Function of the Patients With Dementia of Alzheimer Type
A Phase 4 study testing galantamine hydrobromide in people with Alzheimer Disease, run by Janssen Korea, Ltd., Korea.
Trial summary
The purpose of this study is to assess the efficacy of galantamine on the attention of patients with Alzheimer's Disease, how an improvement of attention of Alzheimer's Disease patients affects their activities of daily living, and the global benefit of galantamine. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- galantamine hydrobromide
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Mar 2004to Nov 2005
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 50 years or older
- Alzheimer's disease according to the criteria of DSM-IV15, NINCDS-ADRDA16
- Measuring standard MMSE-K 10 to 26
- Patients who are literate
- Dementia patients being nursed by the family
- Patients who submitted written consent before entering into the clinical trial (the guardian consent is also effective)
Who cannot join
- If the patient was taking AChEI (Tacrine, Donepezil, Rivastigmine) to treat dementia, the patient can enter into this clinical trial as long as he/she has not taken the drug within 15 days of the beginning of the clinical trial
- Neurodegenerative diseases (e.g. Parkinson's disease, Pick's disease, Huntington's disease, Down syndrome)
- Dementia related to head trauma and dementia related to brain damage due to cerebral hypoxia (hypoxic brain damage after cardiopulmonary resuscitation, hypoxic brain damage after surgery, hypoxic brain damage due to addiction, hypoxic brain damage due to shock)
- brain tumor, nerve syphilis, meningitis, encephalitis, brain tumor
- amentia
- epilepsy
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- major psychiatric patients such as major depression and schizophrenia
- treatment-resistant gastric and peptic ulcer
- patients with clinically serious hepatic, renal, lung, endocrinal or metabolic disease(thyroid, parathyroid, pituitary, renal failure, diabetes mellitus)
- patients complaining of severe difficulty in urination
- patients who have undergone heart surgery within 6 months or patients who experienced myocardial infarction, patients with untreated congestive heart failure, patients with severe disorders in the mitral valve or aortic valve
- patients who have once taken the investigational drugs within the past 1 month from the beginning day of the clinical trial
- patients with uncontrolled diabetes mellitus (if the patient is taking medication and consults the doctor on a regular basis, he/she can participate in this clinical trial)
- patients who experienced hypersensitivity or allergy by a cholinesterase inhibitor
- patients who have not given their consent to the clinical trial, patients who are judged inappropriate to participate in this clinical trial by the investigator
About this study
Official title: A Prospective, Open-labeled, Multicenter Study of Galantamine on the Attention and Frontal Function of the Patients With Dementia of Alzheimer Type
The purpose of this study is to assess the efficacy of galantamine on the attention of patients with Alzheimer's Disease, how an improvement of attention of Alzheimer's Disease patients affects their activities of daily living, and the global benefit of galantamine.
Read the detailed description
Recent studies suggest that an attention deficit occurs at early stage of Alzheimer's disease and affects patients' activities of daily living. In other words, some patients without language or visuospatial dysfunction have severe impairment of activities of daily living, which might result from attention deficit. Another recent clinical study showed that galantamine is more effective in attention and vigilance of Alzheimer's disease patients than donepezil. The study hypothesis is that galantamine will improve attention and frontal executive function in Alzheimer's disease patients and is well-tolerated. 8 mg/day for the first 4 weeks, 16 mg for the next 8 weeks
- Conditions
- Alzheimer Disease
- Being tested
- galantamine hydrobromide
- Keywords
- Alzheimer's disease, galantamine, attention, executive function
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
galantamine hydrobromideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention and Executive function: Visual CPT, Visual Span, Color Trail Making test, Stroop test
Secondary outcomes (1)
Cognition: Mini-Mental Sate Examination-Korean version (MMSE-K);Activities of Daily living: Seoul- Instrumental Activities of daily livings (S-IADL);Behavior: NPI-Q;Global Change: Global Deterioration Scale (GDS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMar 2004
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen Korea, Ltd. Clinical Trial, Study director, Janssen Korea, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216515
- Sponsor's protocol ID
- CR005047
- Status last verified
- Jan 2011
- First submitted
- 13 Sep 2005
- Last updated
- 24 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-labeled, Multicenter Study of Galantamine on the Attention and Frontal Function of the Patients With Dementia of Alzheimer Type
- ClinicalTrials.gov ID
- NCT00216515
- Acronym / sponsor ID
- CR005047
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer's disease, galantamine, attention, executive function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Study completion
- Nov 2005 (actual)
- First posted
- 22 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.
The purpose of this study is to assess the efficacy of galantamine on the attention of patients with Alzheimer's Disease, how an improvement of attention of Alzheimer's Disease patients affects their activities of daily living, and the global benefit of galantamine.
Detailed description
Recent studies suggest that an attention deficit occurs at early stage of Alzheimer's disease and affects patients' activities of daily living. In other words, some patients without language or visuospatial dysfunction have severe impairment of activities of daily living, which might result from attention deficit. Another recent clinical study showed that galantamine is more effective in attention and vigilance of Alzheimer's disease patients than donepezil. The study hypothesis is that galantamine will improve attention and frontal executive function in Alzheimer's disease patients and is well-tolerated. 8 mg/day for the first 4 weeks, 16 mg for the next 8 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients aged 50 years or older
- Alzheimer's disease according to the criteria of DSM-IV15, NINCDS-ADRDA16
- Measuring standard MMSE-K 10 to 26
- Patients who are literate
- Dementia patients being nursed by the family
Key exclusion criteria (15 listed)
- If the patient was taking AChEI (Tacrine, Donepezil, Rivastigmine) to treat dementia, the patient can enter into this clinical trial as long as he/she has not taken the drug within 15 days of the beginning of the clinical trial
- Neurodegenerative diseases (e.g. Parkinson's disease, Pick's disease, Huntington's disease, Down syndrome)
- Dementia related to head trauma and dementia related to brain damage due to cerebral hypoxia (hypoxic brain damage after cardiopulmonary resuscitation, hypoxic brain damage after surgery, hypoxic brain damage due to addiction, hypoxic brain damage due to shock)
- brain tumor, nerve syphilis, meningitis, encephalitis, brain tumor
- amentia
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 |
|---|---|---|
| galantamine hydrobromide | Drug | – |
Primary outcome
Attention and Executive function: Visual CPT, Visual Span, Color Trail Making test, Stroop test
1 secondary outcome
Cognition: Mini-Mental Sate Examination-Korean version (MMSE-K);Activities of Daily living: Seoul- Instrumental Activities of daily livings (S-IADL);Behavior: NPI-Q;Global Change: Global Deterioration Scale (GDS)
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 24 Jan 2011.
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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.
Janssen Korea, Ltd. Clinical Trial study director
Janssen Korea, Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing galantamine hydrobromide in people with Alzheimer Disease, run by Janssen Korea, Ltd., Korea.
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 6 inclusion and 15 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 24 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Attention and Executive function: Visual CPT, Visual Span, Color Trail Making test, Stroop test. 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 24 Jan 2011.