Use of Different Treatment Care Methods in Patients With Dementia Associated With Alzheimer's Disease
REMIND
Review of Management Strategies in Dementia
3 other identifiers
observational
573
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2003
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
January 27, 2006
CompletedFirst Posted
Study publicly available on registry
January 30, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedJanuary 25, 2013
January 1, 2013
3.5 years
January 27, 2006
January 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in Mini Mental State Examination (MMSE) scale score at 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.
Baseline, Month 24
Secondary Outcomes (5)
Change from baseline in clinical global impression (CGI) scale score at Month 24
Baseline, Month 24
Change from baseline in Neuropsychiatric Inventory Questionnaire (NPI-Q) at Month 24
Baseline, Month 24
Change from baseline in Zarit caregiver burden scale score at Month 24
Baseline, Month 24
Change from baseline in Kaplan-Meier estimate at Month 24
Baseline, Month 24
Number of patients with adverse events
Up to 24 months
Study Arms (2)
Galantamine
No Alzheimer's disease (AD) treatment
Interventions
Patients will be prescribed either galantamine or no AD treatment (ie, neither an acetylcholinesterase inhibitor \[AChEI\] nor memantine).
Eligibility Criteria
Patients with demetia with mild to moderate Alzheimer's disease.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ortho-McNeil Neurologics, Inc. Clinical Trial
Ortho-McNeil Neurologics, Inc.
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2006
First Posted
January 30, 2006
Study Start
June 1, 2003
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
January 25, 2013
Record last verified: 2013-01