Alzheimer's Disease Education and Referral Center

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 AgeMax AgeGenderHealthy 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 CityStateZip CodeStatusPrimary Contact

Geolocation is 47.5405059, -122.3045438

Veterans Affairs Puget Sound Health Care System
Seattle
Washington
98108
Recruiting
Name: Lucy Wang, MD
Phone: 206-277-5089
Email: wanglucy@u.washington.edu
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: 
NameRoleAffiliation
Elaine R. Peskind, MD
Principal Investigator
University of Washington, VA Puget Sound Health Care System
Study Contact: 
NamePhoneEmail
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 2015
Disease Stage: 
Early
Middle
Late
Enrollment: 
120