DementiaPhase 4NCT00043849
Treatment of Agitation/Psychosis in Dementia/Parkinsonism (TAP/DAP)
A Phase 4 study testing Quetiapine in people with Dementia and Parkinson Disease, run by National Institute on Aging (NIA) at 21 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Dementia, Parkinson Disease
- What is being tested?
- Quetiapine
- How many people
- 60 participants
- Where
- 21 sitesUnited States
- Study dates
- Jul 2002to Jun 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Parkinson's Disease and Movement Disorders Center, Albany Medical College
Albany, New York, 12205
Emory University, Alzheimer's Disease Center
Atlanta, Georgia, 30322
Medical College of Georgia
Augusta, Georgia, 30912
E. N. Rogers Memorial Veterans Hospital
Bedford, Massachusetts, 01730
Memory Clinic at Southwestern Vermont Medical Center
Bennington, Vermont, 05201
University of Alabama at Birmingham, Alzheimer's Disease Research Center
Birmingham, Alabama, 35233-0017
Maimonides Medical Center
Brooklyn, New York, 11219
Fletcher Allan Health Care, Inc.
Burlington, Vermont, 05401
Rush University Medical Center
Chicago, Illinois, 60612
University of Texas Southwestern Medical Center at Dallas, Alzheimer's Disease Center
Dallas, Texas, 75390-9070
University of California, San Diego, Alzheimer's Disease Center
La Jolla, California, 92037
University of Nevada
Las Vegas, Nevada, 89102
VA Healthcare System Long Beach
Long Beach, California, 90822
University of California at Los Angeles, Alzheimer's Disease Center
Los Angeles, California, 90095-1769
Columbia University, Alzheimer's Disease Research Center
New York, New York, 10032
Stanford/VA Aging Clinical Research Center, Department of Psychiatry & Behavioral Sciences
Palo Alto, California, 94304
University of Pittsburgh, Alzheimer's Disease Research Center
Pittsburgh, Pennsylvania, 15213-2593
University of Rochester Medical Center, Alzheimer's Disease Center
Rochester, New York, 14620
University of Washington at Seattle, Alzheimer's Disease Research Center
Seattle, Washington, 98108-1597
Southern Illinois University, School of Medicine
Springfield, Illinois, 62702
Syracuse VA Medical Center
Syracuse, New York, 13210
About this study
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.
Read the 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.
- Conditions
- Dementia, Parkinson Disease
- Being tested
- Quetiapine
- Keywords
- Psychosis, Agitation, Psychomotor
- Medical subject headings
- Dementia, Parkinson Disease, Psychotic Disorders, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuetiapineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2002 (estimated)
- Study startJul 2002
- Primary completionJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Roger Kurlan, MD, Principal investigator, University of Rochester Medical Center, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00043849
- Sponsor's protocol ID
- IA0034
- Status last verified
- Aug 2006
- First submitted
- 14 Aug 2002
- Last updated
- 11 Dec 2009
- Results posted
- No
Publications
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.
PubMed 10496242Ballard 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.
PubMed 9546516McManus 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.
PubMed 10362435
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Agitation/Psychosis in Dementia/Parkinsonism (TAP/DAP)
- ClinicalTrials.gov ID
- NCT00043849
- Acronym / sponsor ID
- IA0034
- Conditions
- Dementia, Parkinson Disease
- Keywords
- Psychosis, Agitation, Psychomotor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Jul 2002
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 15 Aug 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quetiapine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2009.
- Background: PubMed 10496242Cummings 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.
- Background: PubMed 9546516Ballard 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.
- Background: PubMed 10362435McManus 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Kurlan, MD principal investigator
University of Rochester Medical Center, Department of Neurology
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quetiapine in people with Dementia and Parkinson Disease, run by National Institute on Aging (NIA) at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00043849, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2009.