View Clinical Trial (Medical Research Study)
Alzheimer's in Long-Term Care--Treatment for Agitation
| City: |
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Seattle |
| State: |
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Washington |
| Zip Code: |
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98108 |
| Conditions: |
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Alzheimer Disease - Psychomotor Agitation |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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.
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| NCT ID: |
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NCT00161473 |
| Primary Contact: |
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Principal Investigator
Elaine R Peskind, MD
Veterans Affairs Puget Sound Health Care System
Lucy Wang, MD
Phone: 206-277-5089
Email: wanglucy@u.washington.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Seattle, Washington 98108
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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