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Use of Different Treatment Care Methods in Patients With Dementia Associated With Alzheimer's Disease (REMIND)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ortho-McNeil Neurologics, Inc.
ClinicalTrials.gov Identifier:
NCT00283725
First received: January 27, 2006
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Dementia
Alzheimer's Disease
Other: No intervention
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Review of Management Strategies in Dementia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change from baseline in Mini Mental State Examination (MMSE) scale score at Month 24 [ Time Frame: Baseline, Month 24 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Change from baseline in clinical global impression (CGI) scale score at Month 24 [ Time Frame: Baseline, Month 24 ] [ Designated as safety issue: No ]
    The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients". Higher scores indicate worsening.

  • Change from baseline in Neuropsychiatric Inventory Questionnaire (NPI-Q) at Month 24 [ Time Frame: Baseline, Month 24 ] [ Designated as safety issue: No ]
    The NPI is a validated clinical instrument for evaluating psychopathology in dementia to quantify and qualitate changes in psychiatric symptoms. It has 13-point scale and each is rated as follows: 1= mild (noticeable, but not a significant change), 2= moderate (significant, but not a dramatic change), and 3= Severe (very marked and prominent: a dramatic change). Higher scores indicate worsening.

  • Change from baseline in Zarit caregiver burden scale score at Month 24 [ Time Frame: Baseline, Month 24 ] [ Designated as safety issue: No ]
    Zarit caregiver burden scale is used to measure caregiver burden as it relates to time, developmental comparison with peers, physical health, social relationships, and emotional health. It has 22 item and each question is scored on a 5-point Likert scale ranging from 0 = never present to 4 = nearly always present. The sum of the total scores of the 22-items is calculated in the range from 0 (low burden) to 88 (high burden). Higher scores indicate worsening.

  • Change from baseline in Kaplan-Meier estimate at Month 24 [ Time Frame: Baseline, Month 24 ] [ Designated as safety issue: No ]
    By using Kaplan-Meier Estimator, the effect of an intervention is assessed by measuring the number of patients survived or saved after that intervention is given over a period of time. At any time point, the survival will be measured by the following formula: Number of patients living at the start minus Number of patients died divided by Number of patients living at the start.

  • Number of patients with adverse events [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 573
Study Start Date: June 2003
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Galantamine Other: No intervention
Patients will be prescribed either galantamine or no AD treatment (ie, neither an acetylcholinesterase inhibitor [AChEI] nor memantine).
No Alzheimer's disease (AD) treatment Other: No intervention
Patients will be prescribed either galantamine or no AD treatment (ie, neither an acetylcholinesterase inhibitor [AChEI] nor memantine).

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with demetia with mild to moderate Alzheimer's disease.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Ortho-McNeil Neurologics, Inc.
ClinicalTrials.gov Identifier: NCT00283725     History of Changes
Obsolete Identifiers: NCT01712932
Other Study ID Numbers: CR004636, GALALZ4004, GAL-OUT-065
Study First Received: January 27, 2006
Last Updated: January 24, 2013
Health Authority: United States: None due to nature of the study

Keywords provided by Ortho-McNeil Neurologics, Inc.:
Dementia
Alzheimer's Disease
Acetylcholinesterase inhibitor
Galantamine
Nursing Home Admission

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

ClinicalTrials.gov processed this record on November 20, 2014