Status:
COMPLETED
Alzheimer's in Long-Term Care--Treatment for Agitation
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Alzheimer Disease
Psychomotor Agitation
Eligibility:
All Genders
Phase:
NA
Brief Summary
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 ...
Detailed Description
Although the occurrence of disruptive agitation behaviors likely are influenced by environmental/ interpersonal factors, it is also likely that behaviorally relevant neurobiologic abnormalities lower ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00161473
Start Date
January 1 2001
End Date
September 1 2009
Last Update
August 2 2012
Active Locations (1)
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1
Veterans Affairs Puget Sound Health Care System
Seattle, Washington, United States, 98108