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

This study is currently recruiting participants.
Verified by University of Washington, February 2008

Sponsors and Collaborators: University of Washington
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

Genetics Home Reference related topics:   Alzheimer disease  

MedlinePlus related topics:   Alzheimer's Disease  

ChemIDplus related topics:   Prazosin   Prazosin hydrochloride  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Alzheimer's in Long-Term Care--Treatment for Agitation

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
1: Experimental Drug: prazosin
1-6 mg capsules bid for 8 weeks
2: Placebo Comparator 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: Beth Hutchings, PA-C     1-800-317-5382     elizabeth.hutchings@va.gov    

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
National Institute on Aging (NIA)

Investigators
Principal Investigator:     Elaine R Peskind, MD     Veterans Affairs Puget Sound Health Care System    
  More Information

Responsible Party:   University of Washington School of Medicine/VA Puget Sound Health Care System ( Elaine R. Peskind, MD, Professor, Director of Clinical Research, Mental Health Service )
Study ID Numbers:   99-1794-V
First Received:   September 8, 2005
Last Updated:   February 21, 2008
ClinicalTrials.gov Identifier:   NCT00161473
Health Authority:   United States: Institutional Review Board

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

Study placed in the following topic categories:
Alzheimer Disease
Central Nervous System Diseases
Psychomotor Agitation
Brain Diseases
Neurodegenerative Diseases
Dyskinesias
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Prazosin
Neurologic Manifestations
Dementia
Neurobehavioral Manifestations
Delirium

Additional relevant MeSH terms:
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Cardiovascular Agents
Adrenergic alpha-Antagonists
Antihypertensive Agents
Pharmacologic Actions
Signs and Symptoms
Mental Disorders
Therapeutic Uses
Psychomotor Disorders
Adrenergic Antagonists
Tauopathies

ClinicalTrials.gov processed this record on July 03, 2008




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