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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00161473
• Other study ID #: 16508-A
• Secondary ID: 5R01AG0186445P50
• Status: Completed
• Phase: N/A
• First received: September 8, 2005
• Last updated: June 26, 2012
• Start date: January 2001
• Est. completion date: September 2009

Study information

• Verified date: June 2012
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Psychomotor Agitation

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Veterans Affairs Puget Sound Health Care System	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Clinical Global Impression of Change (CGIC) at Last Observation	The Clinical Global Impression of Change (CGIC) is a 7 point scale, where 1 indicates "markedly improved," 4 indicates "no change," and 7 indicates "markedly worse."	Week 8	No
Primary	Change in Neuropsychiatric Inventory (NPI) Total Score Over the Course of Study Participation	The Neuropsychiatric Inventory (NPI) is a 12-item scale that assesses the frequency and severity of behavioral symptoms in patients with dementia. Each Neuropsychiatric Inventory item ranges from 0 to 12. Therefore the Neuropsychiatric Inventory total score has a minimum total value of 0 and maximum 144, where 144 indicates higher levels of behavioral symptoms.; A change in Neuropsychiatric Inventory total score that is a negative number (that is, an Neuropsychiatric Inventory score decrease), indicates behavioral improvement.	Weeks 2, 4, 6, and 8 (change from Baseline)	No
Secondary	Number of Behavioral Assessment Visits Completed	This measure reflects the length of time participants remained in the study. There were 6 behavioral assessment visits included in the protocol.	Last behavioral assessment (Baseline, Weeks 1, 2, 4, 6, or 8)	No
Secondary	Change in Brief Psychiatric Rating Scale (BPRS) Total Score Over the Course of Study Participation	The Brief Psychiatric Rating Scale (BPRS) is an 18-item scale that rates psychiatric symptoms. Each item ranges from 1 to 7. Therefore, the Brief Psychiatric Rating Scale total score ranges from a minimum of 0 to a maximum of 126, where 126 indicates higher levels of behavioral symptoms.; A change Brief Psychiatric Rating Scale score that is a negative number (that is, a Brief Psychiatric Rating Scale score decrease), indicates behavioral improvement.	Weeks 2, 4, 6, and 8 (change from Baseline)	No