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Sponsored by: |
National Institute on Aging (NIA) |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00043849 |
The primary aim of this study is to determine the safety and efficacy of quetiapine (Seroquel) for the treatment of psychosis and/or agitation in patients with primary dementia complicated by coexistent parkinsonism, or patients with Parkinson's disease with dementia [PDD] who have episodes of agitation or psychosis. The secondary aim is to determine the safety and tolerability, particularly the influence on parkinsonism, of quetiapine when used to treat psychosis and/or agitation in patients with dementia complicated by coexistent parkinsonism.
Condition | Intervention | Phase |
---|---|---|
Dementia Parkinson Disease |
Drug: Quetiapine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Treatment of Agitation/Psychosis in Dementia/Parkinsonism (TAP/DAP) |
Estimated Enrollment: | 60 |
Study Start Date: | July 2002 |
Estimated Study Completion Date: | June 2005 |
Psychosis and agitation often occur in the course of dementia and are a major source of patient disability and caregiver stress. For the common situation in which extrapyramidal (parkinsonian) motor dysfunction accompanies dementia, there is a therapeutic dilemma since the most frequently used drugs to treat the behavioral problems, neuroleptic antipsychotics, can worsen parkinsonism and have been associated with severe extrapyramidal reactions in some types of dementia. To date, the efficacy and tolerability of a promising alternative medication class to treat psychosis and agitation, namely atypical antipsychotics, has not been tested in patients with a primary dementia selected for coexisting parkinsonism.
This is a multicenter double-blind, controlled clinical trial in which 60 subjects with a primary dementia (probable Alzheimer’s disease [AD] or probable dementia with Lewy bodies [DLB]) and coexisting parkinsonism, or Parkinson's disease with dementia [PDD] will be randomized to 1 of 2 treatment groups: (1) quetiapine (QUET); an atypical antipsychotic with a favorable extrapyramidal side effect profile), or (2) placebo. Each subject participates in the trial for 10 weeks and systematic ratings of behavior, motor function, cognition, adverse events and other outcomes occur at baseline and after 6 and 10 weeks of assigned treatment.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Excluded Medications During the Study:
United States, Alabama | |
University of Alabama at Birmingham, Alzheimer's Disease Research Center | |
Birmingham, Alabama, United States, 35233-0017 | |
United States, California | |
University of California at Los Angeles, Alzheimer's Disease Center | |
Los Angeles, California, United States, 90095-1769 | |
University of California, San Diego, Alzheimer's Disease Center | |
La Jolla, California, United States, 92037 | |
VA Healthcare System Long Beach | |
Long Beach, California, United States, 90822 | |
Stanford/VA Aging Clinical Research Center, Department of Psychiatry & Behavioral Sciences | |
Palo Alto, California, United States, 94304 | |
United States, Georgia | |
Emory University, Alzheimer's Disease Center | |
Atlanta, Georgia, United States, 30322 | |
Medical College of Georgia | |
Augusta, Georgia, United States, 30912 | |
United States, Illinois | |
Rush University Medical Center | |
Chicago, Illinois, United States, 60612 | |
Southern Illinois University, School of Medicine | |
Springfield, Illinois, United States, 62702 | |
United States, Massachusetts | |
E. N. Rogers Memorial Veterans Hospital | |
Bedford, Massachusetts, United States, 01730 | |
United States, Nevada | |
University of Nevada | |
Las Vegas, Nevada, United States, 89102 | |
United States, New York | |
Columbia University, Alzheimer's Disease Research Center | |
New York, New York, United States, 10032 | |
Maimonides Medical Center | |
Brooklyn, New York, United States, 11219 | |
University of Rochester Medical Center, Alzheimer's Disease Center | |
Rochester, New York, United States, 14620 | |
Parkinson's Disease and Movement Disorders Center, Albany Medical College | |
Albany, New York, United States, 12205 | |
Syracuse VA Medical Center | |
Syracuse, New York, United States, 13210 | |
United States, Pennsylvania | |
University of Pittsburgh, Alzheimer's Disease Research Center | |
Pittsburgh, Pennsylvania, United States, 15213-2593 | |
United States, Texas | |
University of Texas Southwestern Medical Center at Dallas, Alzheimer's Disease Center | |
Dallas, Texas, United States, 75390-9070 | |
United States, Vermont | |
Fletcher Allan Health Care, Inc. | |
Burlington, Vermont, United States, 05401 | |
Memory Clinic at Southwestern Vermont Medical Center | |
Bennington, Vermont, United States, 05201 | |
United States, Washington | |
University of Washington at Seattle, Alzheimer's Disease Research Center | |
Seattle, Washington, United States, 98108-1597 |
Principal Investigator: | Roger Kurlan, MD | University of Rochester Medical Center, Department of Neurology |
Study ID Numbers: | IA0034 |
Study First Received: | August 14, 2002 |
Last Updated: | August 22, 2006 |
ClinicalTrials.gov Identifier: | NCT00043849 |
Health Authority: | United States: Federal Government |
Psychosis Agitation, Psychomotor |
Ganglion Cysts Basal Ganglia Diseases Central Nervous System Diseases Psychomotor Agitation Brain Diseases Neurodegenerative Diseases Cognition Disorders Schizophrenia Quetiapine |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Parkinson Disease Movement Disorders Psychotic Disorders Parkinsonian Disorders Dementia Schizophrenia and Disorders with Psychotic Features Delirium |
Tranquilizing Agents Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases Psychotropic Drugs |
Central Nervous System Depressants Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions |