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Agitation in Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00000179
Recruitment Status : Completed
First Posted : November 1, 1999
Last Update Posted : June 24, 2005
Information provided by:
National Institute on Aging (NIA)

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

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000179

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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
New York University Medical Center
New York, New York, United States, 10016
Mount Sinai Medical Center
New York, New York, United States, 10029
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
Sponsors and Collaborators
National Institute on Aging (NIA)
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Principal Investigator: Leon Thal, MD. University of California, San Diego
Additional Information:
Publications of Results:
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ClinicalTrials.gov Identifier: NCT00000179    
Other Study ID Numbers: IA0003
3U01AG010483-08S2 ( U.S. NIH Grant/Contract )
First Posted: November 1, 1999    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: March 2005
Keywords provided by National Institute on Aging (NIA):
Alzheimer's disease
Psychomotor agitation
Behavioral symptoms
Anti-psychotic agents
Anti-depressant agents
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Haloperidol decanoate
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Anti-Anxiety Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators