Clinical trial NCT00283725: Use of Different Treatment Care Methods in Patients With Dementia Associated With Alzheimer's Disease
Official title: Review of Management Strategies in Dementia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Alzheimer's Disease
Keywords: Dementia
Alzheimer's Disease
Acetylcholinesterase inhibitor
Galantamine
Nursing Home Admission
Lead sponsor: Ortho-McNeil Neurologics, Inc.
Sponsor class: INDUSTRY
First posted: 2006-01-30
Enrollment: 573
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with demetia with mild to moderate Alzheimer's disease.

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.

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

Primary outcomes:
measure: Change from baseline in Mini Mental State Examination (MMSE) scale score at Month 24
timeFrame: Baseline, Month 24
Secondary outcomes:
measure: Change from baseline in clinical global impression (CGI) scale score at Month 24
timeFrame: Baseline, Month 24
measure: Change from baseline in Neuropsychiatric Inventory Questionnaire (NPI-Q) at Month 24
timeFrame: Baseline, Month 24
measure: Change from baseline in Zarit caregiver burden scale score at Month 24
timeFrame: Baseline, Month 24
measure: Change from baseline in Kaplan-Meier estimate at Month 24
timeFrame: Baseline, Month 24
measure: Number of patients with adverse events
timeFrame: Up to 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Ortho-McNeil Neurologics, Inc.
name: Ortho-McNeil Neurologics, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: