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Alzheimer's in Long-Term Care--Treatment for Agitation
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by University of Washington.   Recruitment status was  Recruiting

First Received on September 8, 2005.   Last Updated on September 28, 2009   History of Changes
Sponsor: University of Washington
Collaborator: National Institute on Aging (NIA)
Information provided by: University of Washington
ClinicalTrials.gov Identifier: NCT00161473
  Purpose

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.


Condition Intervention
Alzheimer Disease
Psychomotor Agitation
Drug: prazosin
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Alzheimer's in Long-Term Care--Treatment for Agitation

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: January 2001
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: prazosin
1-6 mg capsules bid for 8 weeks
Other Name: Minipress
Placebo Comparator: 2 Drug: placebo
placebo capsules bid for 8 weeks

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00161473

Contacts
Contact: Lucy Wang, MD 206-277-5089 wanglucy@u.washington.edu

Locations
United States, Washington
Veterans Affairs Puget Sound Health Care System Recruiting
Seattle, Washington, United States, 98108
Principal Investigator: Elaine R Peskind, MD            
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Elaine R Peskind, MD Veterans Affairs Puget Sound Health Care System
  More Information

Publications:
Responsible Party: Elaine R. Peskind, MD, Professor, Director of Clinical Research, Mental Health Service, University of Washington School of Medicine/VA Puget Sound Health Care System
ClinicalTrials.gov Identifier: NCT00161473     History of Changes
Other Study ID Numbers: 16508-A
Study First Received: September 8, 2005
Last Updated: September 28, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
double-blind
treatment
prazosin

Additional relevant MeSH terms:
Alzheimer Disease
Psychomotor Agitation
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Prazosin
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012