Alzheimer's in Long-Term Care--Treatment for Agitation
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|ClinicalTrials.gov Identifier: NCT00161473|
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : August 2, 2012
Last Update Posted : August 2, 2012
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|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease Psychomotor Agitation||Drug: prazosin Drug: placebo (inert substance)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Alzheimer's in Long-Term Care--Treatment for Agitation|
|Study Start Date :||January 2001|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
|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.
- Mean Clinical Global Impression of Change (CGIC) at Last Observation [ Time Frame: Week 8 ]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) ]
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) ]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) ]
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.
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- No age limit
- probable/possible Alzheimer's disease diagnosis
- disruptive agitated behaviors (e.g., irritability, aggression, uncooperativeness, pacing)
- no hypotension
- no concurrent use of alpha-1-blockers
- no delirium, schizophrenia, mania, psychotic symptoms.
- Cardiovascular: unstable angina, recent myocardial infarction, second or third degree atrioventricular (AV) block, preexisting hypotension (systolic blood pressure less than 110) or orthostatic hypotension
- Other medical exclusions: chronic renal or hepatic failure, or any unstable medical condition
- Exclusionary medications: current treatment with prazosin, other alpha-1-blockers
- Current enrollment in a separate investigational drug trial
- Psychoactive medications: subjects may be psychoactive medication-free or be partial responders (by subjective assessment of referring health care professional) to one psychoactive medication from any of the following classes: antipsychotics, anticonvulsants, mood stabilizers, antidepressants, benzodiazepines, or buspirone. Partial response is defined as some improvement in agitated behavior but persistence of agitated behaviors severe enough to cause patient distress and/or difficulty with caregiving. Although not formally rated, this improvement is equivalent to a Clinical Global Impression of Change (CGIC) rating of no more than minimal improvement (improvement is noticed by not enough to improve patient function or caregiver's practical management of the patient).
- Psychiatric/behavioral: lifetime schizophrenia; current delirium, mania, depression, or uncontrolled persistent distressing psychotic symptoms (hallucinations, delusions), substance abuse, panic disorder, or any behavior which poses an immediate danger to patient or others or which results in the patient being too uncooperative to meet the requirements of study participation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|
|Responsible Party:||University of Washington|
|Other Study ID Numbers:||
5R01AG018644 ( U.S. NIH Grant/Contract )
5P50AG005136 ( U.S. NIH Grant/Contract )
|First Posted:||September 12, 2005 Key Record Dates|
|Results First Posted:||August 2, 2012|
|Last Update Posted:||August 2, 2012|
|Last Verified:||June 2012|
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