About the PEACE-AD Study
The goal of the PEACE-AD clinical trial is to identify a well-tolerated treatment for people with severe agitation in the later stages of Alzheimer’s disease (AD). If you are a family member, caregiver, or friend of a person with AD who frequently experiences disruptive behavior, you may be aware that current treatment approaches to agitation in the advanced stages of AD are not optimal.
PEACE-AD is a phase II, multicenter, randomized, double-blind, placebo-controlled clinical trial of the drug prazosin for disruptive agitation in Alzheimer’s disease. The PEACE-AD trial is taking place at academic medical centers and private clinics across the US that specialize in AD research, treatment and care. PEACE-AD investigators will enroll 186 participants who are living at home, with full time caregiving, or living in memory and long term care communities participating in the PEACE-AD trial.
The PEACE-AD Drug: Prazosin
In PEACE-AD, researchers are testing whether prazosin, an FDA-approved drug developed decades ago to treat high blood pressure, can reduce disruptive behavior in people with moderate to severe Alzheimer’s disease.
The results of a pilot study of prazosin in people with Alzheimer’s disease living in long-term care settings indicate that prazosin may effectively reduce disruptive agitation.
Prazosin is used as a treatment for high blood pressure, enlarged prostate symptoms and post-traumatic stress disorder. Prazosin is rarely sedating and is a selective blocker of brain adrenaline with minimal cardiac effects.
- 2/3 of PEACE-AD participants will receive the study drug
- Participants will take the study drug twice daily (or matching placebo capsules)
- PEACE-AD is a 12 week trial (plus screening and follow-up)
Defining Disruptive Agitation
PEACE-AD defines disruptive agitation as a combination of target behaviors including irritability, physically and/or verbally aggressive behavior, physically resistance to care, and/or pressured motor activity (e.g., pressured pacing).
These behaviors must be problematic and interfere with essential care, disrupt living environments, and/or result in participant and caregiver distress.
PEACE-AD is a phase II, multicenter, randomized, double-blind, placebo-controlled study of the drug prazosin in Alzheimer’s disease. There are eight academic medical centers working with approximately 20 long-term memory care communities in the clinical trial.
Total study participation is up to 22 weeks.
- Screening period up to 30 days
- 12 week treatment on study drug or placebo
- Post-treatment observation/follow-up of 30 days
PEACE-AD Eligibility Requirements
- Males and females with probable or possible AD
- Participants must be experiencing agitation that disrupts their daily life
- Must live at home, with full-time caregiving, or in a memory or long term care community participating in PEACE-AD
- Must have a study partner/caregiver available (home dwelling participants only)
- Must not be bed bound
- No major neurological disorder or unstable illness (other than AD)
The PEACE-AD Partnership
The PEACE-AD Study is a public-private partnership comprised of major academic medical centers, private clinics, and memory and long-term care communities, specializing in Alzheimer’s disease treatment, research, and care. The study is being coordinated by the Alzheimer’s Disease Cooperative Study (ADCS), a national academic research organization involved in clinical trials that span the AD spectrum.
The PEACE-AD Study is funded through grants from the National Institute on Aging, one of the National Institutes of Health (NIH) and the Alzheimer’s Association.
To learn about other research opportunities in Alzheimer’s disease, please contact the Alzheimer’s Disease Education and Referral Center (ADEAR), a service of the National Institute on Aging. 1-800-438-4380 and www.nia.nih.gov/alzheimers
Questions about PEACE-AD?
Contact the Alzheimer’s Disease Cooperative Study
This Study is conducted by The Alzheimer’s Disease Cooperative Study