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

Primary Purpose

Alzheimer Disease, Psychomotor Agitation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
prazosin
placebo (inert substance)
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring double-blind, treatment, prazosin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Veterans Affairs Puget Sound Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

prazosin

placebo (inert substance)

Arm Description

Outcomes

Primary Outcome Measures

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."
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 8, 2005
Last Updated
June 26, 2012
Sponsor
University of Washington
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT00161473
Brief Title
Alzheimer's in Long-Term Care--Treatment for Agitation
Official Title
Alzheimer's in Long-Term Care--Treatment for Agitation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Washington
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Psychomotor Agitation
Keywords
double-blind, treatment, prazosin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
prazosin
Arm Type
Active Comparator
Arm Title
placebo (inert substance)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
prazosin
Other Intervention Name(s)
Minipress
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo (inert substance)
Intervention Description
Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials. Duration is 8 weeks.
Primary Outcome Measure Information:
Title
Mean Clinical Global Impression of Change (CGIC) at Last Observation
Description
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."
Time Frame
Week 8
Title
Change in Neuropsychiatric Inventory (NPI) Total Score Over the Course of Study Participation
Description
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.
Time Frame
Weeks 2, 4, 6, and 8 (change from Baseline)
Secondary Outcome Measure Information:
Title
Number of Behavioral Assessment Visits Completed
Description
This measure reflects the length of time participants remained in the study. There were 6 behavioral assessment visits included in the protocol.
Time Frame
Last behavioral assessment (Baseline, Weeks 1, 2, 4, 6, or 8)
Title
Change in Brief Psychiatric Rating Scale (BPRS) Total Score Over the Course of Study Participation
Description
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.
Time Frame
Weeks 2, 4, 6, and 8 (change from Baseline)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaine R Peskind, MD
Organizational Affiliation
Veterans Affairs Puget Sound Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans Affairs Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19700947
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.
Results Reference
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Alzheimer's in Long-Term Care--Treatment for Agitation

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