the Use of Different Treatment Care Methods in Patients With Dementia Associated With Alzheimer's Disease.
Information source: Ortho-McNeil Neurologics, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alzheimer Disease; Dementia
Phase: Phase 4
Status: Completed
Sponsored by: Ortho-McNeil Neurologics, Inc. Official(s) and/or principal investigator(s):
Ortho McNeil Neurologics, Inc. Clinical Trial, Study Director, Affiliation: Ortho-McNeil Neurologics, Inc.
Summary
The purpose of this observational study is to examine patterns of treatment care for patients
with Alzheimer's disease in a real-world arena and to examine the association with different
outcomes for patients and informal caregivers. New drugs used in the treatment of Alzheimer's
disease have been studied in randomized controlled trials, but it is also important to
observe how these drugs are used in "real life."
Clinical Details
Official title: Review of Management Strategies in Dementia (REMIND)
Study design: Prospective
Detailed description:
Alzheimer's disease is a chronic, progressive syndrome that has an adverse effect on memory,
thinking, comprehension, judgment, orientation, and language. This is the most common type of
dementia, accounting for as much as 50 to 60% of all cases. New pharmacologic agents, such as
galantamine, and conventional acetylcholinesterase inhibitors, such as donepezil and
rivastigmine, have demonstrated efficacy (to differing degrees in different clinical
outcomes) and safety in the treatment of mild and moderate Alzheimer's disease in controlled
clinical trials. Information from randomized controlled trials on the impacts of treatments
for Alzheimer's disease are based on data from select patients who meet strict
inclusion/exclusion criteria, therefore generating a more homogenious sample of patients. In
real life, variability in patient characteristics can be much larger, and the way doctors
prescribe medicines can vary. It is therefore important to examine patterns of treatment care
for patients diagnosed with dementia in this wider arena and to see the association with
different outcomes for patients and informal caregivers. This is a 2-year, multicenter,
prospective, longitudinal, and observational cohort study with an expected enrollment of
about 572 patients. The objective of this study is to examine the way patients with mild and
moderate Alzheimer's disease are currently treated 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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Physician-based diagnosis of mild to moderate Alzheimer's disease (MMSE between
10-24)
- Patients living at home or in a facility for the elderly (e. g., assisted living),
wholive with or have frequent visits from a friend or relative (caregiver) or with a
behavioral symptom (e. g., as agitation or wandering)
- Patients with no plan to change the current treatment plan for at least 90 days
Exclusion Criteria:
- Patients who are using an acetylcholinesterase inhibitor or memantine currently but
have used one in the past 30 days
- Patients residing in or planning to move to a nursing home within the next 90 days or
patients participanting in another clinical trial
Locations and Contacts
Additional Information
Review of Management Strategies in dementia -REMIND
Starting date: June 2003
Ending date: December 2006
Last updated: March 24, 2008
|
