Alzheimer's in Long-Term Care--Treatment for Agitation
The purpose of this study is to see if a medication called prazosin is useful in the treatment of agitation and aggression in persons with Alzheimer's disease (AD) and other types of dementia in late life.
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.
Although the occurrence of disruptive agitation behaviors likely are influenced by environmental/ interpersonal factors, it is also likely that behaviorally relevant neurobiologic abnormalities lower the threshold for the expression of such behavior in Alzheimer's disease. Because of the success prazosin has had in the treatment of Posttraumatic Stress Disorder, it is thought that it could be used similarly with disruptive agitation. Originally designed to evaluate Alzheimer's disease patients in nursing homes, the study now includes outpatients. It is a 9-week placebo-controlled trial.
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|