Cognition DisorderPhase 3NCT00240695
A Follow-up Study to Assess Safety and Tolerability of Galantamine Treatment in Individuals With Mild Cognitive Impairment
A Phase 3 study testing galantamine hydrobromide in people with Cognition Disorder and Nervous System Diseases, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this follow-up study is to assess the long-term safety and tolerability of galantamine in individuals with mild cognitive impairment who participated in a previous study with galantamine Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cognition Disorder, Nervous System Diseases, Mental Disorders
- What is being tested?
- galantamine hydrobromide
- How many people
- 724 participants
- Where
- No sites listed yet
- Study dates
- May 2003to May 2004
- Phase
- Phase 3
- 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
- Completed 24 months of double-blind treatment in 1 of 2 previous studies with galantamine without progressing to dementia (CDR< 1)
- Able to safely receive open-label galantamine in the opinion of the investigator and treatment is in the individual's best interest
- Regular (at least 3 days a week) visits from a person able to accompany patient to scheduled visits
- Enrolled within 7-30 days after the previous galantamine study Exclusion Criteria:
- Individuals who converted to dementia (CDR > = 1) during 1 of the previous galantamine studies
- Prematurely discontinued 1 of the previous galantamine studies or completed 1 of the previous studies more than 30 days prior to this study
- Current clinically significant cardiovascular disease (including heart surgery, unstable angina, congestive heart failure, fibrillation, valve disease or uncontrolled high blood pressure)
Who cannot join
None listed.
About this study
Official title: An Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Galantamine HBr in the Treatment of Mild Cognitive Impairment
The purpose of this follow-up study is to assess the long-term safety and tolerability of galantamine in individuals with mild cognitive impairment who participated in a previous study with galantamine
Read the detailed description
Dementia is a chronic, progressive brain disease that may involve a number of symptoms, including memory loss and changes in personality, behavior, judgment, attention span, language and thought. The most common type of dementia is Alzheimer's disease. Over time, patients with Alzheimer's disease may lose ability to perform daily tasks related to personal care (for example bathing, dressing, eating) and may be unable to handle money or travel to familiar places. The term mild cognitive impairment (MCI) is used to describe individuals who have memory impairments suggestive of early dementia, but do not yet meet the criteria for Alzheimer's disease. Individuals with MCI are more likely to develop Alzheimer's disease than normal elderly patients. Individuals with MCI who completed 1 of 2 previous double-blind studies with galantamine may participate in this follow-up study if they have not progressed to dementia. They will receive open-label galantamine for 12 months and will be evaluated after 2, 6 and 12 months of treatment. Safety evaluations (incidence of adverse events, ECGs, physical examinations, laboratory tests) will be performed throughout the study. Effectiveness will be assessed after 12 months of treatment (by using standardized tests and rating scales (Alzheimer's Disease Assessment Scale: cognitive/MCI version [ADAS-Cog/MCI], Clinical Dementia Rating [CDR] and CDR-Sum of the Boxes [CDR-SB]). Health status will be assessed using the Health Survey portion of the Short-Form 36 (SF-36) and the use of health and social care resources will be assessed using a resource-use questionnaire. The enrolled individuals may participate in an optional portion of the study in which their genetic material is analyzed to see if contains something that would affect the way galantamine is used by their bodies. Galantamine 8 or 12 milligrams (mg) by mouth twice daily for 12 months. Dose will start at 4 mg twice daily and be gradually increased to final dose; 12 mg twice daily dose may be decreased to 8 mg twice daily based upon tolerability
- Being tested
- galantamine hydrobromide
- Keywords
- Alzheimer's disease, Dementia, Brain Disease, Memory Loss, galantamine, Nervous System Diseases, open-label, elderly
- Medical subject headings
- Cognition Disorders, Nervous System Diseases, Mental Disorders, Brain Diseases, Alzheimer Disease, Dementia, Memory Disorders
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.
Incidence of adverse events; Changes in laboratory tests, ECGs, and physical examinations
Secondary outcomes (1)
Change in CDR, ADAS-Cog/MCI version, CDR-SB and SF-36 scores from baseline to end of treatment; resource use; time to conversion to dementia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startMay 2003
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognition DisorderStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 724 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240695
- Sponsor's protocol ID
- CR005947
- Status last verified
- Apr 2010
- First submitted
- 14 Oct 2005
- Last updated
- 18 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of Galantamine HBr in the Treatment of Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT00240695
- Acronym / sponsor ID
- CR005947
- Keywords
- Alzheimer's disease, Dementia, Brain Disease, Memory Loss, galantamine, Nervous System Diseases, open-label, elderly
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 724 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- May 2003
- Study completion
- May 2004 (actual)
- First posted
- 18 Oct 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 follow-up study is to assess the long-term safety and tolerability of galantamine in individuals with mild cognitive impairment who participated in a previous study with galantamine
Detailed description
Dementia is a chronic, progressive brain disease that may involve a number of symptoms, including memory loss and changes in personality, behavior, judgment, attention span, language and thought. The most common type of dementia is Alzheimer's disease. Over time, patients with Alzheimer's disease may lose ability to perform daily tasks related to personal care (for example bathing, dressing, eating) and may be unable to handle money or travel to familiar places. The term mild cognitive impairment (MCI) is used to describe individuals who have memory impairments suggestive of early dementia, but do not yet meet the criteria for Alzheimer's disease. Individuals with MCI are more likely to develop Alzheimer's disease than normal elderly patients. Individuals with MCI who completed 1 of 2 previous double-blind studies with galantamine may participate in this follow-up study if they have not progressed to dementia. They will receive open-label galantamine for 12 months and will be evaluated after 2, 6 and 12 months of treatment. Safety evaluations (incidence of adverse events, ECGs, physical examinations, laboratory tests) will be performed throughout the study. Effectiveness will be assessed after 12 months of treatment (by using standardized tests and rating scales (Alzheimer's Disease Assessment Scale: cognitive/MCI version [ADAS-Cog/MCI], Clinical Dementia Rating [CDR] and CDR-Sum of the Boxes [CDR-SB]). Health status will be assessed using the Health Survey portion of the Short-Form 36 (SF-36) and the use of health and social care resources will be assessed using a resource-use questionnaire. The enrolled individuals may participate in an optional portion of the study in which their genetic material is analyzed to see if contains something that would affect the way galantamine is used by their bodies. Galantamine 8 or 12 milligrams (mg) by mouth twice daily for 12 months. Dose will start at 4 mg twice daily and be gradually increased to final dose; 12 mg twice daily dose may be decreased to 8 mg twice daily based upon tolerability
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 (7 listed)
- Completed 24 months of double-blind treatment in 1 of 2 previous studies with galantamine without progressing to dementia (CDR< 1)
- Able to safely receive open-label galantamine in the opinion of the investigator and treatment is in the individual's best interest
- Regular (at least 3 days a week) visits from a person able to accompany patient to scheduled visits
- Enrolled within 7-30 days after the previous galantamine study Exclusion Criteria:
- Individuals who converted to dementia (CDR > = 1) during 1 of the previous galantamine studies
Key exclusion criteria (0 listed)
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
Incidence of adverse events; Changes in laboratory tests, ECGs, and physical examinations
1 secondary outcome
Change in CDR, ADAS-Cog/MCI version, CDR-SB and SF-36 scores from baseline to end of treatment; resource use; time to conversion to dementia
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 18 May 2011.
- A follow-up study to assess safety and tolerability of galantamine treatment in patients with mild cognitive impairmentLink 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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing galantamine hydrobromide in people with Cognition Disorder and Nervous System Diseases, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 7 inclusion and 0 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 18 May 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Incidence of adverse events; Changes in laboratory tests, ECGs, and physical examinations. 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 18 May 2011.