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

NCT ID: NCT00283725

Last Updated: 2013-01-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 573 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2006-12-31

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.

Conditions

Dementia; Alzheimer's Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Galantamine

No intervention

Intervention Type: OTHER

Patients will be prescribed either galantamine or no AD treatment (ie, neither an acetylcholinesterase inhibitor \[AChEI\] nor memantine).

No Alzheimer's disease (AD) treatment

No intervention

Intervention Type: OTHER

Patients will be prescribed either galantamine or no AD treatment (ie, neither an acetylcholinesterase inhibitor \[AChEI\] nor memantine).

Interventions

No intervention

Patients will be prescribed either galantamine or no AD treatment (ie, neither an acetylcholinesterase inhibitor \[AChEI\] nor memantine).

Intervention Type: OTHER

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ortho-McNeil Neurologics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ortho-McNeil Neurologics, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Ortho-McNeil Neurologics, Inc.

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=918&filename=CR004636_CSR.pdf

Review of Management Strategies in dementia -REMIND

Other Identifiers

GALALZ4004

Identifier Type: OTHER

Identifier Source: secondary_id

GAL-OUT-065

Identifier Type: OTHER

Identifier Source: secondary_id

CR004636

Identifier Type: -

Identifier Source: org_study_id

NCT01712932

Identifier Type: -

Identifier Source: nct_alias