DementiaREMINDNCT00283725
Use of Different Treatment Care Methods in Patients With Dementia Associated With Alzheimer's Disease
An observational study of Dementia and Alzheimer's Disease, run by Ortho-McNeil Neurologics, Inc..
Trial summary
The purpose of this observational study is to examine patterns of treatment care for patients with Alzheimer's disease (AD) in a real-world arena and to examine the association with different outcomes for patients and informal caregivers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia, Alzheimer's Disease
- How many people
- 573 participants
- Where
- No sites listed yet
- Study dates
- Jun 2003to Dec 2006
- 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 demetia with mild to moderate Alzheimer's disease.
Who may be able to join
- Have a physician-based diagnosis of mild to moderate Alzheimer's disease (Mini-Mental State Examination [MMSE] score between 10-24)
- Must be living at home or in a facility for the elderly (eg, assisted living), who live with or have frequent visits from a friend or relative (caregiver) or with a behavioral symptom (eg, as agitation or wandering)
- Have no plan to change the current treatment plan for at least 90 days
Who cannot join
- Have been using an acetylcholinesterase inhibitor or memantine currently but have used one in the past 30 days
- Must be residing in or planning to move to a nursing home within the next 90 days or patients participating in another clinical trial
About this study
Official title: Review of Management Strategies in Dementia
The purpose of this observational study is to examine patterns of treatment care for patients with Alzheimer's disease (AD) in a real-world arena and to examine the association with different outcomes for patients and informal caregivers.
Read the detailed description
This is a 2-year, multicenter, prospective (look forward using periodic observations collected predominantly following patient enrollment), longitudinal (it is a co relational research study that involves repeated observations of the same variables over long periods of time), and observational study. The objective of this study is to examine the patients with mild and moderate AD who are currently being treated with different treatment care methods in real-world settings. Doctors will not be provided medication or asked to treat their patients with any particular treatment. The effect of the different management strategies on cognition, activities of daily living, and behavior of the patients will be evaluated, and data on the informal caregiver burden will be assessed. Data on the utilization of health and social care services by the patient and the primary informal caregiver, including admission of the patient to an assisted living facility or nursing home will be assessed. The doctor's assessment of clinical global impression and adverse events will also be documented. Data will be collected from the doctors at baseline and at 6, 12, and 24 months, and from the caregivers at baseline and 6, 12, 18, and 24 months. The medication dosage and administration is based upon the doctors' prescription, individualized for the patient and not dictated by the protocol.
- Conditions
- Dementia, Alzheimer's Disease
- Being tested
- No intervention
- Keywords
- Dementia, Alzheimer's Disease, Acetylcholinesterase inhibitor, Galantamine, Nursing Home Admission
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Patients will be prescribed either galantamine or no AD treatment (ie, neither an acetylcholinesterase inhibitor [AChEI] nor memantine).
| Study group | Role | What they receive |
|---|---|---|
| Galantamine | Not described Receives: Other: No intervention | |
| No Alzheimer's disease (AD) treatment | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Mini Mental State Examination (MMSE) scale score at Month 24
MMSE is a brief 30-point questionnaire test that is used for the assessment of dementia patients' cognitive impairment. Evaluation of points are as: 24-30 = No cognitive impairment, 18-23 = Mild cognitive impairment, 0-17 = Severe cognitive impairment. Lower scores indicate worsening.
Measured: Baseline, Month 24
Secondary outcomes (5)
Change from baseline in clinical global impression (CGI) scale score at Month 24
The CGI 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". Higher scores indicate worsening.
Measured: Baseline, Month 24
Change from baseline in Neuropsychiatric Inventory Questionnaire (NPI-Q) at Month 24
The NPI is a validated clinical instrument for evaluating psychopathology in dementia to quantify and qualitate changes in psychiatric symptoms. It has 13-point scale and each is rated as follows: 1= mild (noticeable, but not a significant change), 2= moderate (significant, but not a dramatic change), and 3= Severe (very marked and prominent: a dramatic change). Higher scores indicate worsening.
Measured: Baseline, Month 24
Change from baseline in Zarit caregiver burden scale score at Month 24
Zarit caregiver burden scale is used to measure caregiver burden as it relates to time, developmental comparison with peers, physical health, social relationships, and emotional health. It has 22 item and each question is scored on a 5-point Likert scale ranging from 0 = never present to 4 = nearly always present. The sum of the total scores of the 22-items is calculated in the range from 0 (low burden) to 88 (high burden). Higher scores indicate worsening.
Measured: Baseline, Month 24
Change from baseline in Kaplan-Meier estimate at Month 24
By using Kaplan-Meier Estimator, the effect of an intervention is assessed by measuring the number of patients survived or saved after that intervention is given over a period of time. At any time point, the survival will be measured by the following formula: Number of patients living at the start minus Number of patients died divided by Number of patients living at the start.
Measured: Baseline, Month 24
Number of patients with adverse events
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2006 (estimated)
- Study startJun 2003
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 573 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ortho-McNeil Neurologics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ortho-McNeil Neurologics, Inc. Clinical Trial, Study director, Ortho-McNeil Neurologics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283725
- Sponsor's protocol ID
- CR004636
- Other IDs
- GALALZ4004, GAL-OUT-065
- Acronym
- REMIND
- Status last verified
- Jan 2013
- First submitted
- 27 Jan 2006
- Last updated
- 25 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Review of Management Strategies in Dementia
- ClinicalTrials.gov ID
- NCT00283725
- Acronym / sponsor ID
- REMIND / CR004636
- Conditions
- Dementia, Alzheimer's Disease
- Keywords
- Dementia, Alzheimer's Disease, Acetylcholinesterase inhibitor, Galantamine, Nursing Home Admission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 573 participants (actual)
- Lead sponsor
- Ortho-McNeil Neurologics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 30 Jan 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 examine patterns of treatment care for patients with Alzheimer's disease (AD) in a real-world arena and to examine the association with different outcomes for patients and informal caregivers.
Detailed description
This is a 2-year, multicenter, prospective (look forward using periodic observations collected predominantly following patient enrollment), longitudinal (it is a co relational research study that involves repeated observations of the same variables over long periods of time), and observational study. The objective of this study is to examine the patients with mild and moderate AD who are currently being treated with different treatment care methods in real-world settings. Doctors will not be provided medication or asked to treat their patients with any particular treatment. The effect of the different management strategies on cognition, activities of daily living, and behavior of the patients will be evaluated, and data on the informal caregiver burden will be assessed. Data on the utilization of health and social care services by the patient and the primary informal caregiver, including admission of the patient to an assisted living facility or nursing home will be assessed. The doctor's assessment of clinical global impression and adverse events will also be documented. Data will be collected from the doctors at baseline and at 6, 12, and 24 months, and from the caregivers at baseline and 6, 12, 18, and 24 months. The medication dosage and administration is based upon the doctors' prescription, individualized for the patient and not dictated by the protocol.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Galantamine | – | Other: No intervention |
| No Alzheimer's disease (AD) treatment | – | Other: No intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with demetia with mild to moderate Alzheimer's disease.
Key inclusion criteria (3 listed)
- Have a physician-based diagnosis of mild to moderate Alzheimer's disease (Mini-Mental State Examination [MMSE] score between 10-24)
- Must be living at home or in a facility for the elderly (eg, assisted living), who live with or have frequent visits from a friend or relative (caregiver) or with a behavioral symptom (eg, as agitation or wandering)
- Have no plan to change the current treatment plan for at least 90 days
Key exclusion criteria (2 listed)
- Have been using an acetylcholinesterase inhibitor or memantine currently but have used one in the past 30 days
- Must be residing in or planning to move to a nursing home within the next 90 days or patients participating in another clinical trial
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 |
|---|---|---|
| No interventionPatients will be prescribed either galantamine or no AD treatment (ie, neither an acetylcholinesterase inhibitor [AChEI] nor memantine). | Other | Galantamine, No Alzheimer's disease (AD) treatment |
Primary outcome
Change from baseline in Mini Mental State Examination (MMSE) scale score at Month 24
Time frame: Baseline, Month 24
MMSE is a brief 30-point questionnaire test that is used for the assessment of dementia patients' cognitive impairment. Evaluation of points are as: 24-30 = No cognitive impairment, 18-23 = Mild cognitive impairment, 0-17 = Severe cognitive impairment. Lower scores indicate worsening.
5 secondary outcomes
Change from baseline in clinical global impression (CGI) scale score at Month 24
Time frame: Baseline, Month 24
Change from baseline in Neuropsychiatric Inventory Questionnaire (NPI-Q) at Month 24
Time frame: Baseline, Month 24
Change from baseline in Zarit caregiver burden scale score at Month 24
Time frame: Baseline, Month 24
Change from baseline in Kaplan-Meier estimate at Month 24
Time frame: Baseline, Month 24
Number of patients with adverse events
Time frame: Up to 24 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 25 Jan 2013.
- Review of Management Strategies in dementia -REMINDLink 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.
Ortho-McNeil Neurologics, Inc. Clinical Trial study director
Ortho-McNeil Neurologics, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Alzheimer's Disease, run by Ortho-McNeil Neurologics, Inc..
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 3 inclusion and 2 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 25 Jan 2013. 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?
Change from baseline in Mini Mental State Examination (MMSE) scale score at Month 24 (time frame: Baseline, Month 24). 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 25 Jan 2013.