Alzheimer DiseasePhase 3NCT00216502
A Study of the Safety and Effectiveness of Galantamine in Patients With Alzheimer's Disease
A Phase 3 study testing galantamine hydrobromide in people with Alzheimer Disease and Dementia, run by Janssen-Cilag S.p.A..
Trial summary
The purpose of this study is to evaluate the long-term efficacy and safety of galantamine in patients with Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease, Dementia, Mental Disorders
- What is being tested?
- galantamine hydrobromide
- How many people
- 254 participants
- Where
- No sites listed yet
- Study dates
- Aug 2001to Nov 2005
- 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
- Diagnosis of probable Alzheimer's disease according to accepted medical standards
- Patients with mild to moderate impairment of thinking, reasoning, and judgment as defined by a score from 11-24 on the Mini Mental Status Exam (MMSE, a standard assessment tool for Alzheimer's disease) Female patients must be post-menopausal
- Patients and their caregivers must have signed informed consent forms Exclusion Criteria:
- Patients with a diagnosis of Parkinson's Disease, Pick's Disease, Huntington's Chorea, Creutzfeld-Jacob disease, Down's syndrome, brain cancer, mental retardation, epilepsy, psychiatric disease, liver, kidney or heart failure, significant heart, lung, digestive, hormone or mental disease or Vitamin B deficiency
- Patients with previous severe head injury or blood clot in the brain
- Patients who are hospitalized, living in nursing homes or residential care facilities
- Patients with brain infections such as abscess, meningitis, encephalitis
- Patients with a history of drug or alcohol abuse
Who cannot join
None listed.
About this study
Official title: Long Term Treatment With Galantamine In Dementia
The purpose of this study is to evaluate the long-term efficacy and safety of galantamine in patients with Alzheimer's disease.
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. Previous short-term studies have shown galantamine to be safe and effective in treating patients with Alzheimer's disease, however the long-term safety and effectiveness of galantamine have not been examined. This multicenter, randomized study will assess whether long-term treatment with galantamine will delay the onset of symptoms associated with Alzheimer's disease and examine the safety and effectiveness of long-term treatment with galantamine. Patients will receive 12 months of open-label treatment with galantamine, followed by 24 months of double-blind treatment with galantamine or placebo. Safety evaluations (incidence of adverse events, physical examinations, 12 lead ECGs, vital signs, 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 (Mini Mental Status Exam [MMSE], Alzheimer's Disease Assessment Scale [ADAS-cog]; Disability Assessment for Dementia [DAD], and Clinician's Interview Based Impression of Changes plus Family Input [CIBIC-plus]). After the first 4 weeks, assessments will be performed every 3 months during the open-label phase (first 12 months) and then every 6 months during the double-blind phase (13-36 months). Patients whose symptoms worsen as defined by an increase of > or = to 4 points in their ADAS-cog score from the start of the double-blind phase will be withdrawn from the study. The study hypothesis is that long-term treatment with galantamine will be effective in delaying the cognitive deterioration in patients with Alzheimer's disease and that galantamine is well-tolerated with long term treatment. Galantamine 4 milligrams twice daily by mouth for 4 weeks, then 8 milligrams twice daily for 48 weeks. Thereafter, galantamine will be given as 8 milligrams twice daily for an additional 24 months.
- Conditions
- Alzheimer Disease, Dementia, Mental Disorders, Brain Diseases
- Being tested
- galantamine hydrobromide
- Keywords
- Alzheimer's disease, Dementia, galantamine, placebo, Caregiver, Brain disease, Memory loss
- Medical subject headings
- Alzheimer Disease, Dementia, Mental Disorders, Brain Diseases, 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.
Time to worsening of symptoms, defined as the time from the beginning of the double-blind portion of the study to the time of an increase in ADAS-cog score of > or = to 4 points
Secondary outcomes (1)
Change in ADAS-cog, CIBIC-plus and DAD scores over time; Safety parameters assessed by adverse events; laboratory tests, vital signs, weight and ECGs.
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 startAug 2001
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen-Cilag S.p.A. Clinical Trial, Study director, Janssen-Cilag S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216502
- Sponsor's protocol ID
- CR004996
- 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
- Long Term Treatment With Galantamine In Dementia
- ClinicalTrials.gov ID
- NCT00216502
- Acronym / sponsor ID
- CR004996
- Conditions
- Alzheimer Disease, Dementia, Mental Disorders, Brain Diseases
- Keywords
- Alzheimer's disease, Dementia, galantamine, placebo, Caregiver, Brain disease, Memory loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Janssen-Cilag S.p.A.Industry (pharma, biotech, devices)
- Study start
- Aug 2001
- 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 evaluate the long-term efficacy and safety of galantamine in patients with Alzheimer's disease.
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. Previous short-term studies have shown galantamine to be safe and effective in treating patients with Alzheimer's disease, however the long-term safety and effectiveness of galantamine have not been examined. This multicenter, randomized study will assess whether long-term treatment with galantamine will delay the onset of symptoms associated with Alzheimer's disease and examine the safety and effectiveness of long-term treatment with galantamine. Patients will receive 12 months of open-label treatment with galantamine, followed by 24 months of double-blind treatment with galantamine or placebo. Safety evaluations (incidence of adverse events, physical examinations, 12 lead ECGs, vital signs, 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 (Mini Mental Status Exam [MMSE], Alzheimer's Disease Assessment Scale [ADAS-cog]; Disability Assessment for Dementia [DAD], and Clinician's Interview Based Impression of Changes plus Family Input [CIBIC-plus]). After the first 4 weeks, assessments will be performed every 3 months during the open-label phase (first 12 months) and then every 6 months during the double-blind phase (13-36 months). Patients whose symptoms worsen as defined by an increase of > or = to 4 points in their ADAS-cog score from the start of the double-blind phase will be withdrawn from the study. The study hypothesis is that long-term treatment with galantamine will be effective in delaying the cognitive deterioration in patients with Alzheimer's disease and that galantamine is well-tolerated with long term treatment. Galantamine 4 milligrams twice daily by mouth for 4 weeks, then 8 milligrams twice daily for 48 weeks. Thereafter, galantamine will be given as 8 milligrams twice daily for an additional 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of probable Alzheimer's disease according to accepted medical standards
- Patients with mild to moderate impairment of thinking, reasoning, and judgment as defined by a score from 11-24 on the Mini Mental Status Exam (MMSE, a standard assessment tool for Alzheimer's disease) Female patients must be post-menopausal
- Patients and their caregivers must have signed informed consent forms Exclusion Criteria:
- Patients with a diagnosis of Parkinson's Disease, Pick's Disease, Huntington's Chorea, Creutzfeld-Jacob disease, Down's syndrome, brain cancer, mental retardation, epilepsy, psychiatric disease, liver, kidney or heart failure, significant heart, lung, digestive, hormone or mental disease or Vitamin B deficiency
- Patients with previous severe head injury or blood clot in the brain
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
Time to worsening of symptoms, defined as the time from the beginning of the double-blind portion of the study to the time of an increase in ADAS-cog score of > or = to 4 points
1 secondary outcome
Change in ADAS-cog, CIBIC-plus and DAD scores over time; Safety parameters assessed by adverse events; laboratory tests, vital signs, weight and ECGs.
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.
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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 S.p.A. Clinical Trial study director
Janssen-Cilag S.p.A.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing galantamine hydrobromide in people with Alzheimer Disease and Dementia, run by Janssen-Cilag S.p.A..
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 8 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 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 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?
Time to worsening of symptoms, defined as the time from the beginning of the double-blind portion of the study to the time of an increase in ADAS-cog score of > or = to 4 points. 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.