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

University of Washington

Status

Completed

Conditions

Psychomotor Agitation

Alzheimer Disease

Treatments

Drug: placebo (inert substance)

Drug: prazosin

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00161473

5R01AG018644 (U.S. NIH Grant/Contract)

16508-A

5P50AG005136 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

24 patients

Sex

All

Volunteers

No Healthy Volunteers

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.