Alzheimer DiseaseNCT00299676
An Observational Study of the Safety and Effectiveness of Galantamine in the Treatment of Patients With Alzheimer's Disease Over an 18-month Period
An observational study of Alzheimer Disease and Dementia, run by Janssen-Cilag Pty Ltd at 5 sites in Australia.
Trial summary
The purpose of this observational study is to investigate the changes in cognitive functioning, behavior, and functional improvement in Alzheimer's disease patients treated with Galantamine who are living at home (i.e. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer Disease, Dementia, Galantamine
- What is being tested?
- Galantamine (Reminyl)
- How many people
- 61 participants
- Where
- 5 sitesAustralia
- Study dates
- May 2005to Mar 2008
- 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: Patients with Alzheimer's disease, who are currently not in permanent residential care. A convenience sampling method was applied.
Who may be able to join
- Patients prescribed with galantamine according to the approved New Zealand Data Sheet
- The clinical decision to prescribe Galantamine must have been made before and independently of the decision to enroll the patient in this observational study
- The patient should not have commenced Galantamine treatment before the baseline visit
- Patients must be currently living at home (i.e. not in permanent residential care)
- Availability of a supporter who has regular contact with the patient
Who cannot join
- Patients having known hypersensitivity to Galantamine
- Having severe liver impairment or severe kidney impairment
- Suffering from an uncontrolled medical condition other than dementia
- Being treated, or previously treated, with another cholinesterase inhibitor or other cholinomimetics (medications for treating Alzheimer's disease)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Australia5 sites
Study site
Auckland
Study site
Christchurch Nz
Study site
Hamilton
Study site
Porirua
Study site
Tauranga
About this study
Official title: An Observational Study of Clinical Outcomes and Safety Profile of Galantamine in the Treatment of Patients With Alzheimer's Disease Over an 18-month Period
The purpose of this observational study is to investigate the changes in cognitive functioning, behavior, and functional improvement in Alzheimer's disease patients treated with Galantamine who are living at home (i.e. not in permanent residential care), and to obtain information regarding usual clinical practice that can be used for communicating treatment expectations to patients and supporters.
Read the detailed description
This is a prospective, observational study to assess the changes in cognitive functioning, behavior, and functional improvement in Alzheimer's disease patients treated with Galantamine who are living at home (i.e. not in permanent residential care), and to obtain information regarding usual clinical practice performed by relevant specialists. There will be no experimental component associated with this study and all observational activities will be part of routine care. This study will follow patients with Alzheimer's disease, who are currently not in permanent residential care, for a period of 18 months. The three domains of cognition, behavior and function will be evaluated at baseline using the Mini-Mental State Examination (MMSE) and/or ADAS-Cog, the abridged Instrumental Activities of Daily Living (IADL) and a 14-item behavioral assessment scale. Changes in the 3 domains will be observed after 3, 6, 12 and 18 months of Galantamine therapy through the completion of The Clinician Interview Based Impression of Change (CIBIC-Plus), abridged IADL, behavioral changes, and the Mini-Mental State Examination/ADAS-Cog. Primary outcome is to determine changes from baseline in cognition, behavior and function will be assessed after 3, 6, 12, and 18 months as measured by the CIBIC-Plus, abridged IADL, the Mini-Mental State Examination/ADAS-Cog and behavioral changes. The secondary outcome is development of information regarding treatment expectations that can be used for communicating with patients and supporters. Galantamine will be prescribed according to routine clinical practice and as per the Product Information leaflet
- Conditions
- Alzheimer Disease, Dementia, Galantamine
- Being tested
- Galantamine (Reminyl)
- Keywords
- Alzheimer's Disease, Dementia, Post Marketing, Prospective Studies, Longitudinal Studies, New Zealand, Cholinesterase Inhibitors, Observational, Outcomes
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galantamine (Reminyl)Drug
Use of Reminyl according to approved NZ data sheet
| Study group | Role | What they receive |
|---|---|---|
| 001 | Galantamine (Reminyl) Use of Reminyl according to approved NZ data sheet Receives: Drug: Galantamine (Reminyl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate the change in cognitive functioning, clinical and functional improvement, in patients treated with REMINYL in a naturalistic setting.
Measured: Baseline, month 3, month 6, month 12 and month 18.
Secondary outcomes (2)
Development of information regarding treatment expectations that can be used for communicating with patients and supporters.
Measured: Baseline, month 3, month 6, month 12 and month 18.
Gain usage experience in a clinical practice setting that can be used for communicating treatment expectations to patients and carers.
Measured: Baseline, month 3, month 6, month 12 and month 18.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2006 (estimated)
- Study startMay 2005
- Primary completionMar 2008
- Study completionMar 2008
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Pty Ltd Clinical Trial, Study director, Janssen-Cilag Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00299676
- Sponsor's protocol ID
- CR004816
- Status last verified
- May 2014
- First submitted
- 3 Mar 2006
- Last updated
- 23 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Clinical Outcomes and Safety Profile of Galantamine in the Treatment of Patients With Alzheimer's Disease Over an 18-month Period
- ClinicalTrials.gov ID
- NCT00299676
- Acronym / sponsor ID
- CR004816
- Conditions
- Alzheimer Disease, Dementia, Galantamine
- Keywords
- Alzheimer's Disease, Dementia, Post Marketing, Prospective Studies, Longitudinal Studies, New Zealand, Cholinesterase Inhibitors, Observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Janssen-Cilag Pty LtdIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 7 Mar 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 observational study is to investigate the changes in cognitive functioning, behavior, and functional improvement in Alzheimer's disease patients treated with Galantamine who are living at home (i.e. not in permanent residential care), and to obtain information regarding usual clinical practice that can be used for communicating treatment expectations to patients and supporters.
Detailed description
This is a prospective, observational study to assess the changes in cognitive functioning, behavior, and functional improvement in Alzheimer's disease patients treated with Galantamine who are living at home (i.e. not in permanent residential care), and to obtain information regarding usual clinical practice performed by relevant specialists. There will be no experimental component associated with this study and all observational activities will be part of routine care. This study will follow patients with Alzheimer's disease, who are currently not in permanent residential care, for a period of 18 months. The three domains of cognition, behavior and function will be evaluated at baseline using the Mini-Mental State Examination (MMSE) and/or ADAS-Cog, the abridged Instrumental Activities of Daily Living (IADL) and a 14-item behavioral assessment scale. Changes in the 3 domains will be observed after 3, 6, 12 and 18 months of Galantamine therapy through the completion of The Clinician Interview Based Impression of Change (CIBIC-Plus), abridged IADL, behavioral changes, and the Mini-Mental State Examination/ADAS-Cog. Primary outcome is to determine changes from baseline in cognition, behavior and function will be assessed after 3, 6, 12, and 18 months as measured by the CIBIC-Plus, abridged IADL, the Mini-Mental State Examination/ADAS-Cog and behavioral changes. The secondary outcome is development of information regarding treatment expectations that can be used for communicating with patients and supporters. Galantamine will be prescribed according to routine clinical practice and as per the Product Information leaflet
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Drug: Galantamine (Reminyl)Galantamine (Reminyl) Use of Reminyl according to approved NZ data sheet |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Alzheimer's disease, who are currently not in permanent residential care. A convenience sampling method was applied.
Key inclusion criteria (5 listed)
- Patients prescribed with galantamine according to the approved New Zealand Data Sheet
- The clinical decision to prescribe Galantamine must have been made before and independently of the decision to enroll the patient in this observational study
- The patient should not have commenced Galantamine treatment before the baseline visit
- Patients must be currently living at home (i.e. not in permanent residential care)
- Availability of a supporter who has regular contact with the patient
Key exclusion criteria (4 listed)
- Patients having known hypersensitivity to Galantamine
- Having severe liver impairment or severe kidney impairment
- Suffering from an uncontrolled medical condition other than dementia
- Being treated, or previously treated, with another cholinesterase inhibitor or other cholinomimetics (medications for treating Alzheimer's disease)
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 (Reminyl)Use of Reminyl according to approved NZ data sheet | Drug | 001 |
Primary outcome
Investigate the change in cognitive functioning, clinical and functional improvement, in patients treated with REMINYL in a naturalistic setting.
Time frame: Baseline, month 3, month 6, month 12 and month 18.
2 secondary outcomes
Development of information regarding treatment expectations that can be used for communicating with patients and supporters.
Time frame: Baseline, month 3, month 6, month 12 and month 18.
Gain usage experience in a clinical practice setting that can be used for communicating treatment expectations to patients and carers.
Time frame: Baseline, month 3, month 6, month 12 and month 18.
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 23 May 2014.
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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 Pty Ltd Clinical Trial study director
Janssen-Cilag Pty Ltd
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Dementia, run by Janssen-Cilag Pty Ltd at 5 sites in Australia.
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 5 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 23 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. 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.
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?
Investigate the change in cognitive functioning, clinical and functional improvement, in patients treated with REMINYL in a naturalistic setting. (time frame: Baseline, month 3, month 6, month 12 and month 18.). 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 23 May 2014.