Full Text View
Tabular View
No Study Results Posted
Related Studies
Alzheimer's in Long-Term Care--Treatment for Agitation
This study is currently recruiting participants.
Study NCT00161473   Information provided by University of Washington
First Received: September 8, 2005   Last Updated: September 28, 2009   History of Changes

September 8, 2005
September 28, 2009
January 2001
December 2010   (final data collection date for primary outcome measure)
  • CGIC score at last observation [ Time Frame: 8 weeks after baseline ] [ Designated as safety issue: No ]
  • Change from baseline to last observation in NPI total score [ Time Frame: 8 weeks after baseline ] [ Designated as safety issue: No ]
  • 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 study days completed [ Time Frame: 8 weeks after baseline ] [ Designated as safety issue: No ]
  • Change from baseline to last observation in BPRS total score [ Time Frame: 8 weeks after baseline ] [ Designated as safety issue: No ]
  • Number of study days completed
  • Change from baseline to last observation in BPRS total score
 
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 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 AD. Because of the success prazosin has had in the treatment of PTSD, it is thought that it could be used similarly with disruptive agitation. Originally designed to evaluate AD patients in nursing homes, the study now includes outpatients. It is a 9-week placebo-controlled trial.

 
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
  • Alzheimer Disease
  • Psychomotor Agitation
  • Drug: prazosin
  • Drug: placebo
 
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 National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
120
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • No age limit
  • probable/possible AD 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 MI, second or third degree AV block, preexisting hypotension (systolic BP 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 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
 
No
Contact: Lucy Wang, MD 206-277-5089 wanglucy@u.washington.edu
United States
 
NCT00161473
Elaine R. Peskind, MD, Professor, Director of Clinical Research, Mental Health Service, University of Washington School of Medicine/VA Puget Sound Health Care System
16508-A
University of Washington
National Institute on Aging (NIA)
Principal Investigator: Elaine R Peskind, MD Veterans Affairs Puget Sound Health Care System
University of Washington
September 2009

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