Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2001-01-31
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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prazosin
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.
placebo (inert substance)
placebo (inert substance)
Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials. Duration is 8 weeks.
Interventions
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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.
placebo (inert substance)
Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials. Duration is 8 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
University of Washington
OTHER
Responsible Party
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Principal Investigators
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Elaine R Peskind, MD
Role: PRINCIPAL_INVESTIGATOR
Veterans Affairs Puget Sound Health Care System
Locations
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Veterans Affairs Puget Sound Health Care System
Seattle, Washington, United States
Countries
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References
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Wang LY, Shofer JB, Rohde K, Hart KL, Hoff DJ, McFall YH, Raskind MA, Peskind ER. Prazosin for the treatment of behavioral symptoms in patients with Alzheimer disease with agitation and aggression. Am J Geriatr Psychiatry. 2009 Sep;17(9):744-51. doi: 10.1097/JGP.0b013e3181ab8c61.
Other Identifiers
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