Agitation in Alzheimer's Disease

Alzheimer Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000179
• Other study ID #: IA0003
• Secondary ID: 3U01AG010483-08S
• Status: Completed
• Phase: Phase 3
• First received: October 29, 1999
• Last updated: June 23, 2005

Study information

• Verified date: March 2005
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• Trazodone

• Haloperidol

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of Kentucky	Lexington	Kentucky
United States	University of California, Los Angeles	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	University of Minnesota	Minneapolis	Minnesota
United States	Mount Sinai Medical Center	New York	New York
United States	New York University Medical Center	New York	New York
United States	Oregon Health Sciences University	Portland	Oregon
United States	University of Rochester	Rochester	New York
United States	University of California, San Diego	San Diego	California
United States	Southern Illinois University	Springfield	Illinois
United States	University of South Florida	Tampa	Florida
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Teri L, Logsdon RG, Peskind E, Raskind M, Weiner MF, Tractenberg RE, Foster NL, Schneider LS, Sano M, Whitehouse P, Tariot P, Mellow AM, Auchus AP, Grundman M, Thomas RG, Schafer K, Thal LJ; Alzheimer's Disease Cooperative Study. Treatment of agitation in — View Citation