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Agitation in Alzheimer's Disease

This study has been completed.

Sponsored by: 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

Genetics Home Reference related topics:   Alzheimer disease   

MedlinePlus related topics:   Alzheimer's Disease   

Drug Information available for:   Haloperidol    Haloperidol decanoate    Trazodone    Trazodone hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control
  Eligibility
Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000179

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

Sponsors and Collaborators

Investigators
Principal Investigator:     Leon Thal, MD.     University of California, San Diego    
  More Information


The Alzheimer's Disease Education and Referral (ADEAR) Center is a service of the National Institute on Aging (NIA)  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   IA0003, 3U01AG10483-08S2
First Received:   October 29, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00000179
Health Authority:   United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Alzheimer's disease  
Psychomotor agitation  
Behavioral symptoms  
Haloperidol  
Trazodone
Anti-psychotic agents
Anti-depressant agents

Study placed in the following topic categories:
Trazodone
Alzheimer Disease
Central Nervous System Diseases
Psychomotor Agitation
Brain Diseases
Neurodegenerative Diseases
Serotonin
Cognition Disorders
Behavioral Symptoms
Haloperidol
Haloperidol decanoate
Dopamine
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Psychotic Disorders
Dementia
Delirium

Additional relevant MeSH terms:
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Therapeutic Uses
Antidepressive Agents, Second-Generation
Antidepressive Agents
Tranquilizing Agents
Nervous System Diseases
Gastrointestinal Agents
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Anti-Anxiety Agents
Dopamine Agents
Peripheral Nervous System Agents
Tauopathies
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 31, 2008




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