Alzheimer DiseaseNCT00297362
A Study of the Safety and Effectiveness of Galantamine Hydrobromide in Patients With Alzheimer's Disease
An observational study of Alzheimer Disease, run by Janssen Cilag Pharmaceutica S.A.C.I., Greece.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of galantamine hydrobromide in patients with Alzheimer's disease who have not received or have not responded to treatment with medication similar to galantamine hydrobromide. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Galantamine hydrobromide
- How many people
- 344 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Oct 2005
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 247 patients with diagnosed with mild to moderate Alzheimer's disease with a score of 10-26 on the Mini Mental Status Exam. Patients switching from an acetylcholinesterase inhibitor treatment due to lack of efficacy or poor tolerability.
Who may be able to join
- Patients with a score of 10-26 on the Mini Mental Status Exam
- Patients who have not yet received treatment for their Alzheimer's disease with a medication similar to galantamine or patients who have been treated with as medication similar to galantamine hydrobromide and who have discontinued that medication due to lack of effectiveness or poor tolerability (adverse events)
Who cannot join
- Patients with severely decreased liver or kidney function
- Patients with a digestive system or urinary blockage who are recovering from digestive system or urinary bladder surgery
- Patients with clinically significant unstable or uncontrolled hormonal or mental disease
- Patients who are unable to take the medication either alone or with help from another person who is available during the entire study period
About this study
Official title: Open Observational Study of Galantamine Hydrobromide Administration for the Treatment of Patients With Mild to Moderate Dementia of the Alzheimer Type
The purpose of this study is to evaluate the safety and effectiveness of galantamine hydrobromide in patients with Alzheimer's disease who have not received or have not responded to treatment with medication similar to galantamine hydrobromide.
Read the detailed description
Galantamine hydrobromide is a medication that is approved for the treatment of symptoms of Alzheimer's disease. In accordance with international guidelines, studies are conducted after a drug is marketed to continue to evaluate and expand the knowledge regarding its safety. This is a multi-center, open-label (all people involved know the identity of the intervention), observational study (individuals are observed or certain outcomes are measured - no attempt is made to affect the outcome) to collect information regarding the safety and effectiveness of galantamine hydrobromide in patients with Alzheimer's disease. Patients who have been prescribed galantamine hydrobromide as initial treatment with this type of medication for their Alzheimer's disease or who have failed previous treatment with similar medication of this type for their Alzheimer's disease will receive galantamine hydrobromide for 6 months. The individual physicians responsible for the treatment of Alzheimer's disease will administer galantamine hydrobromide at doses appropriate for each patient and will continue to oversee their care. No medication will be supplied by the sponsor of this study. Safety evaluations (incidence of adverse events, physical exams, vital signs and laboratory tests) will be performed throughout the study. Effectiveness will be determined using standard tests and rating scales to assess mental status, functioning, thinking, behavior, judgment and language (Neuropsychiatric Inventory, [NPI], Mini Mental Status Exam [MMSE] and Clinical Global Impression-Caregiver [CGI-Caregiver]). Assessments will be conducted monthly for the first 3 months and at the end of 6 months of treatment. Galantamine hydrobromide treatment should be discontinued if there is no further indication of effectiveness. At the end of the study, the treating physician may continue treatment with galantamine hydrobromide in responding patients as appropriate. The study hypothesis is that galantamine hydrobromide will be effective in treating the symptoms associated with Alzheimer's disease and is safe and well-tolerated. Observational study -No investigational drug administered
- Conditions
- Alzheimer Disease
- Being tested
- Galantamine hydrobromide
- Keywords
- Alzheimer Disease, Dementia, Brain Disease, Memory Loss, Caregiver, Galantamine hydrobromide, Nervous System Diseases, Mental Disorders
- Medical subject headings
- Alzheimer Disease, Dementia, Brain Diseases, Memory Disorders, Nervous System Diseases, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galantamine hydrobromideDrug
247 patients with diagnosed mild to moderate Alzheimer disease.
| Study group | Role | What they receive |
|---|---|---|
| Galantamine hydrobromide | Not described Receives: Drug: Galantamine hydrobromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in Mini-Mental State Examination (MMSE) scale scores
The MMSE is a brief 30-point questionnaire test that is used to screen for cognitive impairment. A score greater than or equal to 25 points is effectively normal (intact). Below this, scores can indicate severe (≤9 points), moderate (10-20 points) or mild (21-24 points) cognitive impairment.
Measured: Baseline to 6 months
Changes from baseline in Disability Assessment for Dementia (DAD) scale scores
The 40-item DAD scale assesses functional abilities in activities of daily living in patients with dementia and other cognitive impairments. Higher scores indicate less disability while lower scores denote more difficulties.
Measured: Baseline to 6 months
Changes from baseline in Neuropsychiatric Inventory (NPI) scale scores
The NPI assesses psychopathology in dementia patients. It evaluates 12 neuropsychiatric disturbances common in dementia: delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavior disturbances, and appetite and eating abnormalities. Both the frequency (from rarely to very often) and the severity (from mild to severe) of each behavior are determined.
Measured: Baseline to 6 months
Changes from baseline in Clinical Global Impression (CGI) scale scores
The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients".
Measured: Baseline to 6 months
Changes from baseline in Cornell Scale
The Cornell Scale assesses signs and symptoms of major depression in patients with dementia. Each item is rated for severity on a scale of 0-2 (0=absent, 1=mild or intermittent, 2=severe). The item scores are added. Scores above 10 indicate a probable major depression. Scores above 18 indicate a definite major depression. Scores below 6 as a rule are associated with absence of significant depressive symptoms.
Measured: Baseline to 6 months
Secondary outcomes (3)
Number of patients with Adverse Events as Measure of Safety and Tolerability
Measured: 6 months
Number of patients whose vital signs fell outside the normal ranges
Measured: 6 months
Number of patients whose laboratory test results fell outside the normal ranges
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2006 (estimated)
- Study startJun 2004
- Study completionOct 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Cilag Pharmaceutica S.A.C.I., Greece
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial, Study director, Janssen-Cilag Pharmaceutica S.A.C.I.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297362
- Sponsor's protocol ID
- CR003559
- Other IDs
- 57504DEM4001
- Status last verified
- Mar 2012
- First submitted
- 24 Feb 2006
- Last updated
- 26 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Observational Study of Galantamine Hydrobromide Administration for the Treatment of Patients With Mild to Moderate Dementia of the Alzheimer Type
- ClinicalTrials.gov ID
- NCT00297362
- Acronym / sponsor ID
- CR003559
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer Disease, Dementia, Brain Disease, Memory Loss, Caregiver, Galantamine hydrobromide, Nervous System Diseases, Mental Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- Janssen Cilag Pharmaceutica S.A.C.I., GreeceIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Study completion
- Oct 2005 (actual)
- First posted
- 28 Feb 2006 (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 evaluate the safety and effectiveness of galantamine hydrobromide in patients with Alzheimer's disease who have not received or have not responded to treatment with medication similar to galantamine hydrobromide.
Detailed description
Galantamine hydrobromide is a medication that is approved for the treatment of symptoms of Alzheimer's disease. In accordance with international guidelines, studies are conducted after a drug is marketed to continue to evaluate and expand the knowledge regarding its safety. This is a multi-center, open-label (all people involved know the identity of the intervention), observational study (individuals are observed or certain outcomes are measured - no attempt is made to affect the outcome) to collect information regarding the safety and effectiveness of galantamine hydrobromide in patients with Alzheimer's disease. Patients who have been prescribed galantamine hydrobromide as initial treatment with this type of medication for their Alzheimer's disease or who have failed previous treatment with similar medication of this type for their Alzheimer's disease will receive galantamine hydrobromide for 6 months. The individual physicians responsible for the treatment of Alzheimer's disease will administer galantamine hydrobromide at doses appropriate for each patient and will continue to oversee their care. No medication will be supplied by the sponsor of this study. Safety evaluations (incidence of adverse events, physical exams, vital signs and laboratory tests) will be performed throughout the study. Effectiveness will be determined using standard tests and rating scales to assess mental status, functioning, thinking, behavior, judgment and language (Neuropsychiatric Inventory, [NPI], Mini Mental Status Exam [MMSE] and Clinical Global Impression-Caregiver [CGI-Caregiver]). Assessments will be conducted monthly for the first 3 months and at the end of 6 months of treatment. Galantamine hydrobromide treatment should be discontinued if there is no further indication of effectiveness. At the end of the study, the treating physician may continue treatment with galantamine hydrobromide in responding patients as appropriate. The study hypothesis is that galantamine hydrobromide will be effective in treating the symptoms associated with Alzheimer's disease and is safe and well-tolerated. Observational study -No investigational drug administered
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Galantamine hydrobromide | – | Drug: Galantamine hydrobromide |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 247 patients with diagnosed with mild to moderate Alzheimer's disease with a score of 10-26 on the Mini Mental Status Exam. Patients switching from an acetylcholinesterase inhibitor treatment due to lack of efficacy or poor tolerability.
Key inclusion criteria (2 listed)
- Patients with a score of 10-26 on the Mini Mental Status Exam
- Patients who have not yet received treatment for their Alzheimer's disease with a medication similar to galantamine or patients who have been treated with as medication similar to galantamine hydrobromide and who have discontinued that medication due to lack of effectiveness or poor tolerability (adverse events)
Key exclusion criteria (4 listed)
- Patients with severely decreased liver or kidney function
- Patients with a digestive system or urinary blockage who are recovering from digestive system or urinary bladder surgery
- Patients with clinically significant unstable or uncontrolled hormonal or mental disease
- Patients who are unable to take the medication either alone or with help from another person who is available during the entire study period
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 hydrobromide247 patients with diagnosed mild to moderate Alzheimer disease. | Drug | Galantamine hydrobromide |
Primary outcome
Changes from baseline in Mini-Mental State Examination (MMSE) scale scores
Time frame: Baseline to 6 months
The MMSE is a brief 30-point questionnaire test that is used to screen for cognitive impairment. A score greater than or equal to 25 points is effectively normal (intact). Below this, scores can indicate severe (≤9 points), moderate (10-20 points) or mild (21-24 points) cognitive impairment.
Changes from baseline in Disability Assessment for Dementia (DAD) scale scores
Time frame: Baseline to 6 months
The 40-item DAD scale assesses functional abilities in activities of daily living in patients with dementia and other cognitive impairments. Higher scores indicate less disability while lower scores denote more difficulties.
Changes from baseline in Neuropsychiatric Inventory (NPI) scale scores
Time frame: Baseline to 6 months
The NPI assesses psychopathology in dementia patients. It evaluates 12 neuropsychiatric disturbances common in dementia: delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavior disturbances, and appetite and eating abnormalities. Both the frequency (from rarely to very often) and the severity (from mild to severe) of each behavior are determined.
Changes from baseline in Clinical Global Impression (CGI) scale scores
Time frame: Baseline to 6 months
The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients".
Changes from baseline in Cornell Scale
Time frame: Baseline to 6 months
The Cornell Scale assesses signs and symptoms of major depression in patients with dementia. Each item is rated for severity on a scale of 0-2 (0=absent, 1=mild or intermittent, 2=severe). The item scores are added. Scores above 10 indicate a probable major depression. Scores above 18 indicate a definite major depression. Scores below 6 as a rule are associated with absence of significant depressive symptoms.
3 secondary outcomes
Number of patients with Adverse Events as Measure of Safety and Tolerability
Time frame: 6 months
Number of patients whose vital signs fell outside the normal ranges
Time frame: 6 months
Number of patients whose laboratory test results fell outside the normal ranges
Time frame: 6 months
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 26 Mar 2012.
- Open Observational Study of Galantamine Hydrobromide Administration for the Treatment of Patients with Mild to Moderate Dementia of the Alzheimer TypeLink provided by the sponsor.
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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-Cilag Pharmaceutica S.A.C.I. Clinical Trial study director
Janssen-Cilag Pharmaceutica S.A.C.I.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Janssen Cilag Pharmaceutica S.A.C.I., Greece.
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 2 inclusion and 4 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 26 Mar 2012. 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.
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?
Changes from baseline in Mini-Mental State Examination (MMSE) scale scores (time frame: Baseline to 6 months). The study lists 5 primary outcomes in all. 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 26 Mar 2012.