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.

Condition	Treatment or Intervention	Phase
Alzheimer Disease	Drug: Trazodone  Drug: Haloperidol	Phase III

Ages Eligible for Study:  50 Years and above,  Genders Eligible for Study:  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

California
      University of California, Los Angeles, Los Angeles,  California,  90095,  United States
      University of California, San Diego, San Diego,  California,  92093-0949,  United States
Florida
      University of Miami, Miami,  Florida,  33140,  United States
      University of South Florida, Tampa,  Florida,  33162,  United States
Georgia
      Emory University, Atlanta,  Georgia,  30329,  United States
Illinois
      Southern Illinois University, Springfield,  Illinois,  62702,  United States
Kansas
      University of Kansas Medical Center, Kansas City,  Kansas,  66160,  United States
Kentucky
      University of Kentucky, Lexington,  Kentucky,  40536,  United States
Massachusetts
      University of Massachusetts, Worcester,  Massachusetts,  01665,  United States
Michigan
      University of Michigan, Ann Arbor,  Michigan,  48109,  United States
Minnesota
      University of Minnesota, Minneapolis,  Minnesota,  55455,  United States
New York
      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
Ohio
      University Hospitals of Cleveland, Cleveland,  Ohio,  44120,  United States
Oregon
      Oregon Health Sciences University, Portland,  Oregon,  97201-3098,  United States

Study chairs or principal investigators

Leon Thal, MD.,  Principal Investigator,  University of California, San Diego   

Study ID Numbers:  IA0003; 3U01AG10483-08S2
Record last reviewed:  March 2005
Last Updated:  March 2, 2005
Record first received:  October 29, 1999
ClinicalTrials.gov Identifier:  NCT00000179
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08