N/A
N=24
Alzheimer's in Long-Term Care--Treatment for Agitation
Alzheimer Disease · Psychomotor Agitation
Bottom Line
View on ClinicalTrials.gov: NCT00161473 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: Mean Clinical Global Impression of Change (CGIC) at Last Observation — 2.6; 4.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- prazosin (Drug); placebo (inert substance) (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Clinical Global Impression of Change (CGIC) at Last Observation |
2.6; 4.5 | — |
| PRIMARY Change in Neuropsychiatric Inventory (NPI) Total Score Over the Course of Study Participation |
-19; -2 | — |
| SECONDARY Number of Behavioral Assessment Visits Completed |
4.8; 4.5 | — |
| SECONDARY Change in Brief Psychiatric Rating Scale (BPRS) Total Score Over the Course of Study Participation |
-9; -3 | — |
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 (AD) and other types of dementia in late life.
Eligibility Criteria
Inclusion Criteria
- No age limit
- probable/possible Alzheimer's disease 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 myocardial infarction, second or third degree atrioventricular (AV) block, preexisting hypotension (systolic blood pressure 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 Clinical Global Impression of Change (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.
Data sourced from ClinicalTrials.gov (NCT00161473). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.