- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00283725
Use of Different Treatment Care Methods in Patients With Dementia Associated With Alzheimer's Disease (REMIND)
January 24, 2013 updated by: Ortho-McNeil Neurologics, Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
573
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with demetia with mild to moderate Alzheimer's disease.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Galantamine
|
Patients will be prescribed either galantamine or no AD treatment (ie, neither an acetylcholinesterase inhibitor [AChEI] nor memantine).
|
No Alzheimer's disease (AD) treatment
|
Patients will be prescribed either galantamine or no AD treatment (ie, neither an acetylcholinesterase inhibitor [AChEI] nor memantine).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, Month 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in clinical global impression (CGI) scale score at Month 24
Time Frame: Baseline, 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.
|
Baseline, Month 24
|
Change from baseline in Neuropsychiatric Inventory Questionnaire (NPI-Q) at Month 24
Time Frame: Baseline, 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.
|
Baseline, Month 24
|
Change from baseline in Zarit caregiver burden scale score at Month 24
Time Frame: Baseline, 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.
|
Baseline, Month 24
|
Change from baseline in Kaplan-Meier estimate at Month 24
Time Frame: Baseline, 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.
|
Baseline, Month 24
|
Number of patients with adverse events
Time Frame: Up to 24 months
|
Up to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ortho-McNeil Neurologics, Inc. Clinical Trial, Ortho-McNeil Neurologics, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2003
Primary Completion (ACTUAL)
December 1, 2006
Study Completion (ACTUAL)
December 1, 2006
Study Registration Dates
First Submitted
January 27, 2006
First Submitted That Met QC Criteria
January 27, 2006
First Posted (ESTIMATE)
January 30, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
January 25, 2013
Last Update Submitted That Met QC Criteria
January 24, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR004636
- GALALZ4004 (OTHER: Ortho-McNeil Neurologics, Inc.)
- GAL-OUT-065 (OTHER: Ortho-McNeil Neurologics, Inc.)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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