Agitation in Alzheimer's Disease

Condition(s) targeted: Alzheimer Disease

Intervention: Trazodone (Drug); Haloperidol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: National Institute on Aging (NIA)

Official(s) and/or principal investigator(s):
Leon Thal, MD., Principal Investigator, Affiliation: University of California, San Diego

Agitation affects 70 to 90 percent of patients with AD. Signs of agitation include verbal and physical aggressiveness, irritability, wandering, and restlessness. These behaviors often make caring for patients at home very difficult. Trazodone and haldol are two of the most commonly prescribed drugs for agitation in AD patients. Behavior management, a non drug approach, has been effective in reducing signs of agitation. Researchers have yet to compare the effectiveness of drug versus non drug therapy to treat agitation in AD patients and determine which is the best treatment. The Alzheimer's Disease Cooperative Study, with funding from the National Institute on Aging, is conducting an agitation treatment program at 21 sites in 16 States. This study will assess which of the above treatments is most effective.

Study design: Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Memory problem consistent with a probable diagnosis of Alzheimer's disease (AD)

- Agitation symptoms for at least the past 2 weeks

- Patient has caregiver who can participate

- Patient lives in the same household as the caregiver

University of California, Los Angeles, Los Angeles, California 90095, United States

University of California, San Diego, San Diego, California 92093-0949, United States

University of Miami, Miami, Florida 33140, United States

University of South Florida, Tampa, Florida 33162, United States

Emory University, Atlanta, Georgia 30329, United States

Southern Illinois University, Springfield, Illinois 62702, United States

University of Kansas Medical Center, Kansas City, Kansas 66160, United States

University of Kentucky, Lexington, Kentucky 40536, United States

University of Massachusetts, Worcester, Massachusetts 01665, United States

University of Michigan, Ann Arbor, Michigan 48109, United States

University of Minnesota, Minneapolis, Minnesota 55455, United States

Mount Sinai Medical Center, New York, New York 10029, United States

New York University Medical Center, New York, New York 10016, United States

University of Rochester, Rochester, New York 14620, United States

University Hospitals of Cleveland, Cleveland, Ohio 44120, United States

Oregon Health Sciences University, Portland, Oregon 97201-3098, United States

The Alzheimer's Disease Education and Referral (ADEAR) Center is a service of the National Institute on Aging (NIA)

Last updated: June 23, 2005