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

Completed

• Conditions: Dementia; Alzheimer's Disease
• Interventions: Other: No intervention

• Registration Number: NCT00283725
• Lead Sponsor: Ortho-McNeil Neurologics, Inc.

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.

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2006-01-27
• Study First Submitted QC: 2006-01-27
• Study First Posted: 2006-01-30
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-24
• Last Update Posted: 2013-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 573

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Galantamine	No intervention	-
No Alzheimer's disease (AD) treatment	No intervention	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in Mini Mental State Examination (MMSE) scale score at Month 24	Baseline, Month 24	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

Name	Time	Method
Change from baseline in clinical global impression (CGI) scale score at Month 24	Baseline, Month 24	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	Baseline, Month 24	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	Baseline, Month 24	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	Baseline, Month 24	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	Up to 24 months