Prazosin Treatment for Disruptive Agitation in Alzheimer's Disease
Prazosin Treatment for Disruptive Agitation in Alzheimer's Disease
Overall Status:
Recruiting
Brief Description:
This study will examine participants with Alzheimer's disease or a related dementia who have difficult behaviors that are upsetting for them or their caregivers. Research with prazosin, a medication commonly used to treat people with high blood pressure, has shown that it may be effective in treating behavioral problems in people with dementia.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
N/A | N/A | Both | No |
Inclusion Criteria:
- No age limit
- Probable or possible Alzheimer's disease
- Disruptive agitated behaviors at least twice a week (overly anxious or excited, making offensive comments, etc.)
- Stable medications for 2 weeks
- Caregiver who spends at least 10 hours per week caring for the participant and agrees to participate in all evaluation sessions
Exclusion Criteria:
- Cardiovascular disease: unstable angina, recent myocardial infarction, preexisting hypotension (systolic blood pressure of less than 110 mmHg) or orthostatic hypotension (≥20 mmHg drop in systolic blood pressure following 2 minutes of standing posture)
- Any unstable medical condition
- Free of psychoactive medications or partial responder (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.
- Lifetime schizophrenia
- Current delirium; mania; depression; uncontrolled, persistent, distressing psychotic symptoms (e.g., hallucinations, delusions); substance abuse; panic disorder
- Any behavior that poses an immediate danger to patient or others or that results in the patient being too uncooperative to meet the requirements of study participation
- Prohibited medications: Current treatment with prazosin or other alpha-1 blockers (trazodone, sildenafil, vardenafil, or tadalafil)
Detailed Description:
This study will examine participants with Alzheimer's disease or a related dementia who have difficult behaviors that are upsetting for them or their caregivers. Participants will be treated with prazosin, a medication commonly used to treat people with high blood pressure, to see if it is effective in treating behavioral problems by reducing excess adrenalin effects in the brain.
This is a 24-week study with 14 visits to the research clinic. Approximately six of these visits may be done by phone. Additional phone checks are scheduled at the beginning of each 12-week part of the study. Participants will have a 50/50 chance of being on prazosin or a placebo (a sugar pill) in the first 12 weeks of the study. For the second 12 weeks, all participants will take prazosin. Study visits include a physical and neurological exam, memory testing, interviews with the caregiver about behaviors, and vital signs.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 47.5405059, -122.3045438 | VA Puget Sound | Seattle | Washington | 98108 | Recruiting |
Lead Sponsor:
| Agency |
|---|
Seattle Institute for Biomedical and Clinical Research |
Collaborator Sponsor:
| Agency |
|---|
National Institute on Aging (NIA) |
VA Puget Sound Health Care System |
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Elaine R. Peskind, MD | Principal Investigator | University of Washington, VA Puget Sound Health Care System |
Study Contact:
| Name | Phone | |
|---|---|---|
Lucy Wang, MD | 206-277-5089 |
Locations
ClinicalTrials.gov ID
NCT01126099 (follow link to view full record on ct.gov in new window)
Official Title:
Prazosin Treatment for Disruptive Agitation in Alzheimer's Disease
Study Start Date:
March 2010
Study End Date:
July 2014
Disease Stage:
Early
Middle
Late
Enrollment:
120
