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| 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."
| Study Type: | Observational |
| Study Design: | Prospective |
| Official Title: | Review of Management Strategies in Dementia (REMIND) |
| Estimated Enrollment: | 572 |
| Study Start Date: | June 2003 |
| Study Completion Date: | December 2006 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| 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 |
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acetylcholinesterase inhibitor Alzheimer Disease Observational Nursing Home Admission |
caregiver Alzheimer's dementia |
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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 |