Agitation in Alzheimer's Disease

Sponsor

National Institute on Aging (NIA) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000179

Collaborator

(none)

Locations

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease	Drug: Trazodone Drug: Haloperidol	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Masking:

Double

Primary Purpose:

Treatment

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Los Angeles	Los Angeles	California	United States	90095
2	University of California, San Diego	San Diego	California	United States	92093-0949
3	University of Miami	Miami	Florida	United States	33140
4	University of South Florida	Tampa	Florida	United States	33162
5	Emory University	Atlanta	Georgia	United States	30329
6	Southern Illinois University	Springfield	Illinois	United States	62702
7	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
8	University of Kentucky	Lexington	Kentucky	United States	40536
9	University of Massachusetts	Worcester	Massachusetts	United States	01665
10	University of Michigan	Ann Arbor	Michigan	United States	48109
11	University of Minnesota	Minneapolis	Minnesota	United States	55455
12	New York University Medical Center	New York	New York	United States	10016
13	Mount Sinai Medical Center	New York	New York	United States	10029
14	University of Rochester	Rochester	New York	United States	14620
15	University Hospitals of Cleveland	Cleveland	Ohio	United States	44120
16	Oregon Health Sciences University	Portland	Oregon	United States	97201-3098