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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00161473
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : August 2, 2012
Last Update Posted : August 2, 2012
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Washington

Tracking Information
First Submitted Date  ICMJE September 8, 2005
First Posted Date  ICMJE September 12, 2005
Results First Submitted Date  ICMJE February 24, 2012
Results First Posted Date  ICMJE August 2, 2012
Last Update Posted Date August 2, 2012
Study Start Date  ICMJE January 2001
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2012)
  • Mean Clinical Global Impression of Change (CGIC) at Last Observation [ Time Frame: Week 8 ]
    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) ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
  • CGIC score at last observation
  • Change from baseline to last observation in NPI total score
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2012)
  • Number of Behavioral Assessment Visits Completed [ Time Frame: Last behavioral assessment (Baseline, Weeks 1, 2, 4, 6, or 8) ]
    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) ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
  • Number of study days completed
  • Change from baseline to last observation in BPRS total score
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alzheimer's in Long-Term Care--Treatment for Agitation
Official Title  ICMJE Alzheimer's in Long-Term Care--Treatment for Agitation
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Alzheimer Disease
  • Psychomotor Agitation
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: prazosin
    Intervention: Drug: prazosin
  • Placebo Comparator: placebo (inert substance)
    Intervention: Drug: placebo (inert substance)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 26, 2012)		 24
Original Enrollment  ICMJE
 (submitted: September 8, 2005)		 120
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00161473
Other Study ID Numbers  ICMJE 16508-A
5R01AG018644 ( U.S. NIH Grant/Contract )
5P50AG005136 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Washington
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE University of Washington
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Elaine R Peskind, MD Veterans Affairs Puget Sound Health Care System
PRS Account University of Washington
Verification Date June 2012

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