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Treatment of Agitation/Psychosis in Dementia/Parkinsonism (TAP/DAP) Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Treatment of Agitation/Psychosis in Dementia/Parkinsonism (TAP/DAP) conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Treatment of Agitation/Psychosis in Dementia/Parkinsonism (TAP/DAP) Clinical research trials and Treatment of Agitation/Psychosis in Dementia/Parkinsonism (TAP/DAP) health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Treatment of Agitation/Psychosis in Dementia/Parkinsonism (TAP/DAP). Treatment of Agitation/Psychosis in Dementia/Parkinsonism (TAP/DAP) Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Treatment of Agitation/Psychosis in Dementia/Parkinsonism (TAP/DAP) clinical trial. Subjects frequently get the best healthcare possible for their Treatment of Agitation/Psychosis in Dementia/Parkinsonism (TAP/DAP) condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Treatment of Agitation/Psychosis in Dementia/Parkinsonism (TAP/DAP)  Treatment of Agitation/Psychosis in Dementia/Parkinsonism (TAP/DAP)
Treatment of Agitation/Psychosis in Dementia/Parkinsonism (TAP/DAP)
For Condition: Dementia,Parkinson Disease
Status: Recruiting
Sponsor(s): National Institute on Aging (NIA) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 50 Years/
Genders: Both
Protocol Entry Criteria: - Fluent in English or Spanish. - Presence of dementia as defined by the Diagnostic and Statistical Manual of Psychiatry, 4th ed. (DSM-IV) American Psychiatric Association. 1994. - Meets NINDS/ADRDA diagnostic criteria for probable Alzheimer's disease [AD] or Consortium diagnostic criteria for probable dementia with Lewy bodies [DLB] or diagnostic criteria for Parkinson's disease with dementia [PDD]. - Presence of psychosis and/or agitation that interferes with daily activities: a) psychosis, b) hallucination, c) delusion, or d) agitation. - Presence of 2 or more of the following extrapyramidal motor features: a) resting tremor, b) bradykinesia, c) limb rigidity, d) shuffling, short-stepped gait. - Sum of ratings for the resting tremor, bradykinesia, rigidity and gait items of the Unified Parkinson's Disease Rating Scale (UPDRS) motor examination component must be greater than or equal to 2. - Brief Psychiatric Rating Scale (BPRS) score greater than or equal to 12. - Informed consent by participant or an appropriate proxy. - Spouse/caregiver who is willing and able to accompany the subject to all clinic visits. - A stable dosage of non-excluded medications for at least 2 weeks prior to the Screening Visit. - Is in a stable medical condition for at least 4 weeks prior to the Screening Visit. - Physically acceptable for this study as confirmed by medical history, physical exam and clinical laboratory tests. - Must be able to ingest oral medications. - Supervision must be available for administration of study medication. - Taking any marketed cholinesterase inhibitor (donepezil [Aricept], rivastigmine [Exelon], galantamine [Reminyl], tacrine [Cognex], and/or memantine at a dose unchanged for at least 2 weeks prior to the screening visit. - Participants may reside in their own home or in a supervised care setting, such as a nursing home. Exclusion Criteria: - Mini Mental Status Examination Score <8. - Use of any of the following in the 3 weeks prior to the screening visit: (a) a neuroleptic or atypical antipsychotic medication; or (b) an anticholinergic drug, amantadine for the treatment of parkinsonism [treatment with levodopa (Sinemet, Sinemet CR) and any dopamine agonist, selegiline or entacapone is allowed]. - A history of a severe adverse reaction to any antipsychotic medication. - A serious medical illness that would preclude the safe administration of quetiapine, including active cancer. Skin tumors other than malignant melanoma are not exclusionary. Patients with stable prostate cancer may be included at the discretion of the Program Director. - Current evidence or history in the last 2 years of epilepsy, focal brain lesion, head injury with loss of consciousness and/or immediate confusion after the injury. - Known pregnancy. Excluded Medications During the Study: - a. Any classical neuroleptic antipsychotic, such as haloperidol (Haldol). •b. Any atypical antipsychotic, such as risperidone (Risperidal), quetiapine (Seroquel), ziprasidone (Geodon), olanzapine (Zyprexa) and clozapine (Clozaril). •c. Any anxiolytic other than lorazepam (Ativan), as described above. This includes clonazepam (Klonopin), diazepam (Valium), oxazepam (Serax), clozazepate (Tranxene), buspirone (Buspar) and hydroxyzine (Vistaril). •d. Any hypnotic other than lorazepam (Ativan), as described above. This includes estazolam (Prosom), flurazepam (Dalmane), quazepam (Doral), temazepam (Restoril), triazolam (Halcion), diphenhydramine (Benadryl), doxylamine (Unisom), zolpidem (Ambien), zaleplon (Sonata) and chloral hydrate.
Total Enrollment: 60
Location and Contact Information:
Overall Study Official:
RogerKurlan, Principal Investigator, University of Rochester Medical Center, Department of Neurology
VA Healthcare System Long Beach *Recruiting*
Long Beach, California, 90822
United States
Recruiting Jennifer Koontz 562-826-8000
University of California, San Diego, Alzheimer's Disease Center *Recruiting*
La Jolla, California, 92037
United States
Recruiting Deborah Fontaine 858-622-5800
Emory University, Alzheimer's Disease Center *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting Janet Cellar 404-728-6453
Fletcher Allan Health Care, Inc. *Recruiting*
Burlington, Vermont, 05401
United States
Recruiting Donna DeWitt 802-847-2295
University of Texas Southwestern Medical Center at Dallas, Alzheimer's Disease Center *Recruiting*
Dallas, Texas, 75390-9070
United States
Recruiting Kathleen Koch 214-648-7462
Southern Illinois University, School of Medicine *Recruiting*
Springfield, Illinois, 62702
United States
Recruiting Sandy Vicari 217-545-7671
Columbia University, Alzheimer's Disease Research Center *Recruiting*
New York City, New York, 10032
United States
Recruiting Ruth Tejeda 212-305-7661
Maimonides Medical Center *Recruiting*
Brooklyn, New York, 11219
United States
Recruiting Denise Cheng 718-283-8625
Syracuse VA Medical Center *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Linda Schad 315-425-3473
University of Pittsburgh, Alzheimer's Disease Research Center *Recruiting*
Pittsburgh, Pennsylvania, 15213-2593
United States
Recruiting Thomas Baumgartner 412-692-2716
E. N. Rogers Memorial Veterans Hospital *Recruiting*
Bedford, Massachusetts, 01730
United States
Recruiting Colleen Cormier 781-687-2845
Northwestern University, Northwestern Behavioral Pharmacology Program *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Jenelle Fleck 312-695-6929
University of California at Los Angeles, Alzheimer's Disease Center *Recruiting*
Los Angeles, California, 90095-1769
United States
Recruiting Kavitar Shankar 310-206-3779
Parkinson's Disease and Movement Disorders Center, Albany Medical College *Recruiting*
Albany, New York, 12205
United States
Recruiting Sharon Evans 518-452-0914
University of Alabama at Birmingham, Alzheimer's Disease Research Center *Recruiting*
Birmingham, Alabama, 35233-0017
United States
Recruiting JoAnn Parrish 205-934-6223
Rush University Medical Center *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Julie Bach 312-942-8264
Arizona Health Sciences Center *Recruiting*
Tucson, Arizona, 85724-5023
United States
Recruiting Pete Arambula 520-626-0868
University of Rochester Medical Center, Alzheimer's Disease Center *Recruiting*
Rochester, New York, 14620
United States
Recruiting Debra Berry 585-341-7514
University of Nevada *Recruiting*
Las Vegas, Nevada, 89102
United States
Recruiting Gail Vranesh 702-671-5079
Memory Clinic at Southwestern Vermont Medical Center *Recruiting*
Bennington, Vermont, 05201
United States
Recruiting Rita Burgher 802-447-1409
University of Washington at Seattle, Alzheimer's Disease Research Center *Recruiting*
Seattle, Washington, 98108-1597
United States
Recruiting Nghia Pham 206-277-3949
Additional Information:
Study ID Numbers: IA0034;
Study Start Date: July 2002
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043849
Other Parkinson Disease Studies:
1. Treatment of Agitation/Psychosis in Dementia/Parkinsonism (TAP/DAP)
2. Brain Study of Patients with Frontal Lobe Dementia and Parkinsonian Disorders
3. Honolulu Heart Program
4. Nurse Managed Clinic for Dementia Patients and Family Caregivers
5. Preventing Cognitive Decline with Alternative Therapies
Related Studies:
Other Parkinson Disease Clinical Trials
Other New York Clinical Trials
Other Brooklyn Clinical Trials
Treatment of Agitation/Psychosis in Dementia/Parkinsonism (TAP/DAP)
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