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the Use of Different Treatment Care Methods in Patients With Dementia Associated With Alzheimer's Disease.
This study has been completed.
First Received: January 27, 2006   Last Updated: March 24, 2008   History of Changes
Sponsor: Ortho-McNeil Neurologics, Inc.
Information provided by: Ortho-McNeil Neurologics, Inc.
ClinicalTrials.gov Identifier: NCT00283725
  Purpose

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."


Condition Phase
Alzheimer Disease
Dementia
Phase IV

Study Type: Observational
Study Design: Prospective
Official Title: Review of Management Strategies in Dementia (REMIND)

Resource links provided by NLM:


Further study details as provided by Ortho-McNeil Neurologics, Inc.:

Estimated Enrollment: 572
Study Start Date: June 2003
Study Completion Date: December 2006
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00283725

Sponsors and Collaborators
Ortho-McNeil Neurologics, Inc.
Investigators
Study Director: Ortho McNeil Neurologics, Inc. Clinical Trial Ortho-McNeil Neurologics, Inc.
  More Information

Additional Information:
No publications provided

Study ID Numbers: CR004636
Study First Received: January 27, 2006
Last Updated: March 24, 2008
ClinicalTrials.gov Identifier: NCT00283725     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Ortho-McNeil Neurologics, Inc.:
acetylcholinesterase inhibitor
Alzheimer Disease
Observational
Nursing Home Admission
caregiver
Alzheimer's
dementia

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Alzheimer Disease
Nervous System Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Cholinergic Agents
Brain Diseases
Neurodegenerative Diseases
Pharmacologic Actions
Cholinesterase Inhibitors
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dementia
Tauopathies

ClinicalTrials.gov processed this record on February 08, 2010