Alzheimer's in Long-Term Care--Treatment for Agitation
Drug: placebo (inert substance)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Alzheimer's in Long-Term Care--Treatment for Agitation|
- Mean Clinical Global Impression of Change (CGIC) at Last Observation [ Time Frame: Week 8 ] [ Designated as safety issue: No ]The Clinical Global Impression of Change (CGIC) is a 7 point scale, where 1 indicates "markedly improved," 4 indicates "no change," and 7 indicates "markedly worse."
- Change in Neuropsychiatric Inventory (NPI) Total Score Over the Course of Study Participation [ Time Frame: Weeks 2, 4, 6, and 8 (change from Baseline) ] [ Designated as safety issue: No ]
The Neuropsychiatric Inventory (NPI) is a 12-item scale that assesses the frequency and severity of behavioral symptoms in patients with dementia. Each Neuropsychiatric Inventory item ranges from 0 to 12. Therefore the Neuropsychiatric Inventory total score has a minimum total value of 0 and maximum 144, where 144 indicates higher levels of behavioral symptoms.
A change in Neuropsychiatric Inventory total score that is a negative number (that is, an Neuropsychiatric Inventory score decrease), indicates behavioral improvement.
- Number of Behavioral Assessment Visits Completed [ Time Frame: Last behavioral assessment (Baseline, Weeks 1, 2, 4, 6, or 8) ] [ Designated as safety issue: No ]This measure reflects the length of time participants remained in the study. There were 6 behavioral assessment visits included in the protocol.
- Change in Brief Psychiatric Rating Scale (BPRS) Total Score Over the Course of Study Participation [ Time Frame: Weeks 2, 4, 6, and 8 (change from Baseline) ] [ Designated as safety issue: No ]
The Brief Psychiatric Rating Scale (BPRS) is an 18-item scale that rates psychiatric symptoms. Each item ranges from 1 to 7. Therefore, the Brief Psychiatric Rating Scale total score ranges from a minimum of 0 to a maximum of 126, where 126 indicates higher levels of behavioral symptoms.
A change Brief Psychiatric Rating Scale score that is a negative number (that is, a Brief Psychiatric Rating Scale score decrease), indicates behavioral improvement.
|Study Start Date:||January 2001|
|Study Completion Date:||September 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
|Active Comparator: prazosin||
Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
Duration was 8 weeks.
Other Name: Minipress
|Placebo Comparator: placebo (inert substance)||
Drug: placebo (inert substance)
Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials. Duration is 8 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00161473
|United States, Washington|
|Veterans Affairs Puget Sound Health Care System|
|Seattle, Washington, United States, 98108|
|Principal Investigator:||Elaine R Peskind, MD||Veterans Affairs Puget Sound Health Care System|