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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00161473
First received: September 8, 2005
Last updated: June 26, 2012
Last verified: June 2012

September 8, 2005
June 26, 2012
January 2001
September 2009   (final data collection date for primary outcome measure)
  • Mean Clinical Global Impression of Change (CGIC) at Last Observation [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Weeks 2, 4, 6, and 8 (change from Baseline) ] [ Designated as safety issue: No ]

    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.

  • CGIC score at last observation
  • Change from baseline to last observation in NPI total score
Complete list of historical versions of study NCT00161473 on ClinicalTrials.gov Archive Site
  • Number of Behavioral Assessment Visits Completed [ Time Frame: Last behavioral assessment (Baseline, Weeks 1, 2, 4, 6, or 8) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Weeks 2, 4, 6, and 8 (change from Baseline) ] [ Designated as safety issue: No ]

    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.

  • Number of study days completed
  • Change from baseline to last observation in BPRS total score
Not Provided
Not Provided
 
Alzheimer's in Long-Term Care--Treatment for Agitation
Alzheimer's in Long-Term Care--Treatment for Agitation

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Alzheimer Disease
  • Psychomotor Agitation
  • 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.

    Other Name: Minipress
  • Drug: placebo (inert substance)
    Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials. Duration is 8 weeks.
  • Active Comparator: prazosin
    Intervention: Drug: prazosin
  • Placebo Comparator: placebo (inert substance)
    Intervention: Drug: placebo (inert substance)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
September 2009
September 2009   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00161473
16508-A, 5R01AG018644, 5P50AG005136
Yes
University of Washington
University of Washington
National Institute on Aging (NIA)
Principal Investigator: Elaine R Peskind, MD Veterans Affairs Puget Sound Health Care System
University of Washington
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP