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

NCT00043849 | Completed Phase 4

• 1 other identifier: IA0034
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 21

Brief Summary

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.

Conditions

Dementia; Parkinson Disease

Keywords

Psychosis; Agitation, Psychomotor

Interventions

Quetiapine DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National Institute on Aging (NIA): lead

Study Sites (21)

University of Alabama at Birmingham, Alzheimer's Disease Research Center

Birmingham, Alabama, 35233-0017, United States

Location

University of California, San Diego, Alzheimer's Disease Center

La Jolla, California, 92037, United States

Location

VA Healthcare System Long Beach

Long Beach, California, 90822, United States

Location

University of California at Los Angeles, Alzheimer's Disease Center

Los Angeles, California, 90095-1769, United States

Location

Stanford/VA Aging Clinical Research Center, Department of Psychiatry & Behavioral Sciences

Palo Alto, California, 94304, United States

Location

Emory University, Alzheimer's Disease Center

Atlanta, Georgia, 30322, United States

Location

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Southern Illinois University, School of Medicine

Springfield, Illinois, 62702, United States

Location

E. N. Rogers Memorial Veterans Hospital

Bedford, Massachusetts, 01730, United States

Location

University of Nevada

Las Vegas, Nevada, 89102, United States

Location

Parkinson's Disease and Movement Disorders Center, Albany Medical College

Albany, New York, 12205, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Columbia University, Alzheimer's Disease Research Center

New York, New York, 10032, United States

Location

University of Rochester Medical Center, Alzheimer's Disease Center

Rochester, New York, 14620, United States

Location

Syracuse VA Medical Center

Syracuse, New York, 13210, United States

Location

University of Pittsburgh, Alzheimer's Disease Research Center

Pittsburgh, Pennsylvania, 15213-2593, United States

Location

University of Texas Southwestern Medical Center at Dallas, Alzheimer's Disease Center

Dallas, Texas, 75390-9070, United States

Location

Memory Clinic at Southwestern Vermont Medical Center

Bennington, Vermont, 05201, United States

Location

Fletcher Allan Health Care, Inc.

Burlington, Vermont, 05401, United States

Location

University of Washington at Seattle, Alzheimer's Disease Research Center

Seattle, Washington, 98108-1597, United States

Location

Related Publications (3)

• Cummings JL, Knopman D. Advances in the treatment of behavioral disturbances in Alzheimer's disease. Neurology. 1999 Sep 22;53(5):899-901. doi: 10.1212/wnl.53.5.899. No abstract available.

  PMID: 10496242 BACKGROUND

• Ballard C, Grace J, McKeith I, Holmes C. Neuroleptic sensitivity in dementia with Lewy bodies and Alzheimer's disease. Lancet. 1998 Apr 4;351(9108):1032-3. doi: 10.1016/s0140-6736(05)78999-6. No abstract available.

  PMID: 9546516 BACKGROUND

• McManus DQ, Arvanitis LA, Kowalcyk BB. Quetiapine, a novel antipsychotic: experience in elderly patients with psychotic disorders. Seroquel Trial 48 Study Group. J Clin Psychiatry. 1999 May;60(5):292-8.

  PMID: 10362435 BACKGROUND

MeSH Terms

Conditions

Dementia; Parkinson Disease; Psychotic Disorders; Psychomotor Agitation

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Dyskinesias; Neurologic Manifestations; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Roger Kurlan, MD

  University of Rochester Medical Center, Department of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 14, 2002
• First Posted: August 15, 2002
• Study Start: July 1, 2002
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2005
• Last Updated: December 11, 2009

Record last verified: 2006-08

Locations

US (21)