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 in Alzheimer’s disease. There are eight academic medical centers working with approximately 20 long-term memory care communities in the clinical trial. PEACE-AD will enroll 186 participants residing in memory and long term care communities participating in the PEACE-AD trial.

Finding effective treatments for AD-related disruptive agitation would address a significant, unmet, public health need.

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.

Defining Disruptive Agitation in the PEACE-AD Trial

Senior Woman Comforting Man With Depression At Home

For people with Alzheimer’s disease, and for their friends and family members, disruptive agitation can be frequent, and distressing. Disruptive agitation includes a group of behaviors that are highly prevalent in the later stages of AD and often clustered together. In the PEACE-AD clinical trial, researchers have defined disruptive agitation to include:

  • Irritability and anger outbursts
  • Physical resistance to necessary care
  • Verbal and/or physical aggression
  • Pressured motor hyperactivity (e.g. pressured pacing).

Trial Basics

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.

Study Duration

Total study participation duration is approximately 18 weeks.

  • Screening period up to 14 days
  • Duration of treatment of 12 weeks
  • Post-treatment observation/follow-up of 30 days

Participant Information and Requirements:

  • 186 participants residing in memory and long-term care communities participating in PEACE-AD
  • 2/3 of PEACE-AD participants will receive the study drug
  • Participants will take prazosin capsules twice daily (or matching placebo capsules)
  • PEACE-AD will be a 12 week trial (plus two-week screening period)
  • PEACE-AD participants must be experiencing moderate to severe agitation and aggression 5 times or more per week

The PEACE-AD Partnership

The PEACE-AD Study is a public-private partnership comprised of major academic medical centers and memory and long-term care communities specializing in Alzheimer’s disease treatment, research, and care. This study is being coordinated by the Alzheimer’s Disease Cooperative Study (ADCS), a national academic research organization specialized in clinical trials that span the Alzheimer’s disease spectrum. The PEACE-AD Study is funded through a grant from the National Institute on Aging, one of the National Institutes of Health (NIH).

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
www.nia.nih.gov/alzheimers

Questions about PEACE-AD?