Clinical trial NCT00161473: Alzheimer's in Long-Term Care--Treatment for Agitation
Official title: Alzheimer's in Long-Term Care--Treatment for Agitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Psychomotor Agitation
Keywords: double-blind
treatment
prazosin
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2005-09-12
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 life.

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 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.

Eligibility 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.

Primary outcomes:
measure: Mean Clinical Global Impression of Change (CGIC) at Last Observation
timeFrame: Week 8
measure: Change in Neuropsychiatric Inventory (NPI) Total Score Over the Course of Study Participation
timeFrame: Weeks 2, 4, 6, and 8 (change from Baseline)
Secondary outcomes:
measure: Number of Behavioral Assessment Visits Completed
timeFrame: Last behavioral assessment (Baseline, Weeks 1, 2, 4, 6, or 8)
measure: Change in Brief Psychiatric Rating Scale (BPRS) Total Score Over the Course of Study Participation
timeFrame: Weeks 2, 4, 6, and 8 (change from Baseline)
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Veterans Affairs Puget Sound Health Care System
state: Washington
Study officials:
affiliation: Veterans Affairs Puget Sound Health Care System
name: Elaine R Peskind, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.