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

This study is currently recruiting participants.
Information provided by University of Washington

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Descriptive Information Fields
Brief Title  Alzheimer's in Long-Term Care--Treatment for Agitation
Official Title  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 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 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.

Study Phase
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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 ]
Secondary Outcome Measure  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 ]
Condition  Alzheimer Disease
Psychomotor Agitation
Intervention  Drug: prazosin
Drug: placebo
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  120
Start Date  January 2001
Completion Date December 2010
Eligibility Criteria 

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.
Gender Both
Ages
Accepts Healthy Volunteers No
Contacts ††
Contact: Beth Hutchings, PA-C     1-800-317-5382     elizabeth.hutchings@va.gov    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00161473
Organization ID 99-1794-V
Secondary IDs ††
Study Sponsor  University of Washington
Collaborators †† National Institute on Aging (NIA)
Investigators 
Principal Investigator:     Elaine R Peskind, MD     Veterans Affairs Puget Sound Health Care System    
Information Provided By University of Washington
Verification Date February 2008
First Received Date  September 8, 2005
Last Updated Date February 21, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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