Treatment of Agitation/Psychosis in Dementia/Parkinsonism (TAP/DAP)

This study has been completed.
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00043849
First received: August 14, 2002
Last updated: December 10, 2009
Last verified: August 2006
  Purpose

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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Treatment of Agitation/Psychosis in Dementia/Parkinsonism (TAP/DAP)

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Estimated Enrollment: 60
Study Start Date: July 2002
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Detailed Description:

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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:

  • Any classical neuroleptic antipsychotic, such as haloperidol (Haldol).
  • Any atypical antipsychotic, such as risperidone (Risperidal), quetiapine (Seroquel), ziprasidone (Geodon), olanzapine (Zyprexa) and clozapine (Clozaril).
  • Any anxiolytic other than lorazepam (Ativan), as described above. This includes clonazepam (Klonopin), diazepam (Valium), oxazepam (Serax), clorazepate (Tranxene), buspirone (Buspar) and hydroxyzine (Vistaril).
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043849

Locations
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, San Diego, Alzheimer's Disease Center
La Jolla, California, United States, 92037
VA Healthcare System Long Beach
Long Beach, California, United States, 90822
University of California at Los Angeles, Alzheimer's Disease Center
Los Angeles, California, United States, 90095-1769
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
Parkinson's Disease and Movement Disorders Center, Albany Medical College
Albany, New York, United States, 12205
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Columbia University, Alzheimer's Disease Research Center
New York, New York, United States, 10032
University of Rochester Medical Center, Alzheimer's Disease Center
Rochester, New York, United States, 14620
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
Memory Clinic at Southwestern Vermont Medical Center
Bennington, Vermont, United States, 05201
Fletcher Allan Health Care, Inc.
Burlington, Vermont, United States, 05401
United States, Washington
University of Washington at Seattle, Alzheimer's Disease Research Center
Seattle, Washington, United States, 98108-1597
Sponsors and Collaborators
Investigators
Principal Investigator: Roger Kurlan, MD University of Rochester Medical Center, Department of Neurology
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00043849     History of Changes
Other Study ID Numbers: IA0034
Study First Received: August 14, 2002
Last Updated: December 10, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Psychosis
Agitation, Psychomotor

Additional relevant MeSH terms:
Parkinson Disease
Dementia
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 29, 2014