Review of Management Strategies in Dementia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dementia
- Sponsor
- Ortho-McNeil Neurologics, Inc.
- Enrollment
- 573
- Primary Endpoint
- Change from baseline in Mini Mental State Examination (MMSE) scale score at Month 24
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief 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.
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change from baseline in clinical global impression (CGI) scale score at Month 24(Baseline, Month 24)
- Change from baseline in Neuropsychiatric Inventory Questionnaire (NPI-Q) at Month 24(Baseline, Month 24)
- Change from baseline in Zarit caregiver burden scale score at Month 24(Baseline, Month 24)
- Change from baseline in Kaplan-Meier estimate at Month 24(Baseline, Month 24)
- Number of patients with adverse events(Up to 24 months)