Overview

Alzheimer's in Long-Term Care--Treatment for Agitation

Status:
Completed
Trial end date:
2009-09-01
Target enrollment:
0
Participant gender:
All
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 life.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Washington
Collaborator:
National Institute on Aging (NIA)
Treatments:
Prazosin
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.