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| Sponsor: | National Institute on Aging (NIA) |
|---|---|
| Information provided by: | National Institute on Aging (NIA) |
| ClinicalTrials.gov Identifier: | NCT00000179 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Alzheimer Disease |
Drug: Trazodone Drug: Haloperidol |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment |
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations| United States, California | |
| University of California, Los Angeles | |
| Los Angeles, California, United States, 90095 | |
| University of California, San Diego | |
| San Diego, California, United States, 92093-0949 | |
| United States, Florida | |
| University of Miami | |
| Miami, Florida, United States, 33140 | |
| University of South Florida | |
| Tampa, Florida, United States, 33162 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30329 | |
| United States, Illinois | |
| Southern Illinois University | |
| Springfield, Illinois, United States, 62702 | |
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Kentucky | |
| University of Kentucky | |
| Lexington, Kentucky, United States, 40536 | |
| United States, Massachusetts | |
| University of Massachusetts | |
| Worcester, Massachusetts, United States, 01665 | |
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, New York | |
| Mount Sinai Medical Center | |
| New York, New York, United States, 10029 | |
| New York University Medical Center | |
| New York, New York, United States, 10016 | |
| University of Rochester | |
| Rochester, New York, United States, 14620 | |
| United States, Ohio | |
| University Hospitals of Cleveland | |
| Cleveland, Ohio, United States, 44120 | |
| United States, Oregon | |
| Oregon Health Sciences University | |
| Portland, Oregon, United States, 97201-3098 | |
| Principal Investigator: | Leon Thal, MD. | University of California, San Diego |
More Information
| ClinicalTrials.gov Identifier: | NCT00000179 History of Changes |
| Other Study ID Numbers: | IA0003, 3U01AG10483-08S2 |
| Study First Received: | October 29, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Federal Government |
|
Alzheimer's disease Psychomotor agitation Behavioral symptoms Haloperidol |
Trazodone Anti-psychotic agents Anti-depressant agents |
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Trazodone Haloperidol Haloperidol decanoate Antipsychotic Agents Anti-Anxiety Agents Tranquilizing Agents |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Antidepressive Agents, Second-Generation Antidepressive Agents Antiemetics Autonomic Agents |
