Alzheimer's DiseaseNCT00015548
CATIE-Alzheimer's Disease Trial
A study testing Olanzapine, Quetiapine and Risperidone in people with Alzheimer's Disease, run by National Institute of Mental Health (NIMH) at 34 sites in United States.
Trial summary
The CATIE Alzheimer's Disease Trial is part of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Project. The study is for people with Alzheimer's disease who are having trouble with their thinking or behavior. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Olanzapine, Quetiapine and Risperidone
- How many people
- 450 participants
- Where
- 34 sitesUnited States
- Study dates
- Mar 2001to Oct 2004
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of Dementia of the Alzheimer's Type
- Ambulatory, Outpatients who have an informant living/visiting at least 8 hours/week over 3-4 days.
- Presence of delusions, hallucinations, agitation impacting functioning and requiring medication treatment
- Agitation or psychotic symptoms began after signs or symptoms of dementia
Who cannot join
- Be benefiting from psychotropic medication, antidepressants or anticonvulsants
- Be diagnosed with schizophrenia, schizoaffective disorder, delusional disorder or mood disorder with psychotic features.
- Have severe or unstable medical illness requiring active treatment
- Have hypersensitivity or intolerance of any of the study medications
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Emory University - Wesley Woods Health Center
Atlanta, Georgia, 30329
Johns Hopkins University
Baltimore, Maryland, 21287
Southwestern Vermont Medical Center- The Memory Clinic
Bennington, Vermont, 05201
Mental Health Advocates, Inc.
Boca Raton, Florida, 33432
Northwestern University Medical School
Chicago, Illinois, 60611
VA Medical Center
Coatesville, Pennsylvania, 19320
University of Texas Southwestern Medical Center
Dallas, Texas, 75235-9070
Duke University Medical Center
Durham, North Carolina, 27710
Berma Research Group
Hialeah, Florida, 33016
University of Hawaii
Honolulu, Hawaii, 96813
University of Iowa College of Medicine
Iowa City, Iowa, 52242
University of California, Irvine Medical Center
Irvine, California, 92697
University of Southern California Dept of Psychiatry& Behavioral Sciences
Los Angeles, California, 90033
University of California, Los Angeles, VA Medical Center
Los Angeles, California, 90073
Yale University School of Medicine
New Haven, Connecticut, 06510
Mount Sinai School of Medicine
New York, New York, 10029
Columbia University
New York, New York, 10032
Medical University of South Carolina
North Charleston, South Carolina, 29406
Global Research and Consulting
Olean, New York, 14760
Mental Illness Research Education and Clinical Center
Philadelphia, Pennsylvania, 19104
University of Medicine and Dentistry of New Jersey
Piscataway, New Jersey, 08855-1382
Monroe Community Hospital
Rochester, New York, 14620
University of California-San Diego, VA Medical Center
San Diego, California, 92161
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 71103
Southern Illinois School of Medicine
Springfield, Illinois, 62702
Millennium Psychiatric Associates
St Louis, Missouri, 63044
Stanford University School of Medicine
Stanford, California, 94305
Staten Island University Hospital
Staten Island, New York, 10305
University of Medicine and Dentistry of New Jersey-Stratford
Stratford, New Jersey, 08084
University of South Florida Suncoast Gerontology Center
Tampa, Florida, 33617
Tuscaloosa VA Medical Center
Tuscaloosa, Alabama, 35404
Palm Beach Neurology/Premiere Research Institute
West Palm Beach, Florida, 33407
University Hospital Health Systems-Laurelwood Hospital
Willoughby, Ohio, 44904
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: Comparative Effectiveness of Antipsychotic Medications in Patients With Alzheimer's Disease (CATIE Alzheimer's Disease Trial)
The CATIE Alzheimer's Disease Trial is part of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Project. The study is for people with Alzheimer's disease who are having trouble with their thinking or behavior. In particular, this study is trying to find out the best treatment for people who have hallucinations (seeing or hearing things that aren't there), delusions (false beliefs), or agitation. The design of the trial helps to increase the chance that participants in the study receive a medication that helps them. The study uses three medications known as atypical antipsychotics (olanzapine, quetiapine, risperidone), which are the newest medications that are currently available for treating these problems. Participants may also receive an antidepressant (citalopram). The trial lasts for 36 weeks. Participants are given a thorough evaluation at no cost to ensure that this study is appropriate. In addition, the caregiver, family member, or friend who comes with the participant will be offered an educational program about Alzheimer's disease.
Read the detailed description
There are four phases.
Phase I: In the initial treatment phase (Phase 1), patients will be randomized to one of the three atypical antipsychotics or placebo in the ratio 100:100:100:150 respectively. After two weeks, the investigator can move the patient to the next phase because of lack of efficacy or tolerability. At week 12, the investigator can decide whether the current medication is sufficiently optimal or it would be more beneficial to try another randomized medication.
Phase 2: Phase 2 starts when the patient is randomized to a second medication, i.e., olanzapine, quetiapine, risperidone, or citalopram. Patients will be randomized from an antipsychotic treatment to another antipsychotic treatment or citalopram in the ratio 3:3:2, or from placebo to an antipsychotic treatment or citalopram in the ratio 1:1:1:3 respectively. Therefore, 50% of patients who took placebo in Phase 1 will be randomized to an antipsychotic in Phase 2, and 50% will be randomized to citalopram in Phase 2. After the initial two weeks in Phase 2, the investigator can move the patient to the next phase, due to lack of efficacy or tolerability. After the patient has been on the Phase 2 study drug for approximately 12 weeks, the investigator can decide whether the current medication is sufficiently optimal or whether it would be more beneficial to try another randomized medication.
Phase 3: Phase 3 is randomized open-label treatment of one of the medications not previously received, i.e., olanzapine, quetiapine, risperidone, or citalopram. Treatment failures to the second treatment can be switched to a third open-label treatment. During Phase 3 patients will be maintained on their treatments openly and managed clinically until week 36.
If the investigator determines that the patient's response is not sufficiently optimal to the randomized open-label medication, then after the first two weeks of Phase 3, the investigator can prescribe another medication (of the investigator's choice) to the patient. If this occurs then patients are classed as being in the Open-Choice Phase.
Open-Choice Phase: The Open-Choice Phase can be entered at anytime during the 36-week study and directly from any of the three phases. There are four reasons a patient can enter the open choice phase:
- Withdrawal from Phase 1 or Phase 2 with the patient or surrogate decision-maker refusing to proceed to the next randomized phase;
- Withdrawal from Phase 3;
- Withdrawal from current study drug from any of the three previous phases due to antipsychotic medication no longer being required in the opinion of the investigator; or
- Withdrawal due to concomitant treatment with an exclusionary medication.
The Open-Choice Phase is designed to keep patients monitored in the trial for the 36-week duration.
- Conditions
- Alzheimer's Disease
- Being tested
- Olanzapine, Quetiapine, Risperidone, Citalopram
- Keywords
- antipsychotic treatment, Alzheimer's disease, agitation, dementia, psychosis, behavioral symptoms, hallucinations, delusions
- Medical subject headings
- Alzheimer Disease, Psychomotor Agitation, Dementia, Psychotic Disorders, Behavioral Symptoms, Hallucinations, Delusions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
QuetiapineDrug
RisperidoneDrug
CitalopramDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2001 (estimated)
- Study startMar 2001
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 450 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Lon Schneider, MD, Principal investigator, University of Southern CaliforniaPierre Tariot, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00015548
- Sponsor's protocol ID
- N01 MH090001-05
- Other IDs
- N01 MH90001-AD, DSIR AT, N01MH90001, N01MH090001
- Status last verified
- Feb 2009
- First submitted
- 20 Apr 2001
- Last updated
- 17 Jun 2015
- Results posted
- No
Publications
Schneider LS, Tariot PN, Lyketsos CG, Dagerman KS, Davis KL, Davis S, Hsiao JK, Jeste DV, Katz IR, Olin JT, Pollock BG, Rabins PV, Rosenheck RA, Small GW, Lebowitz B, Lieberman JA. National Institute of Mental Health Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE): Alzheimer disease trial methodology. Am J Geriatr Psychiatry. 2001 Fall;9(4):346-60.
PubMed 11739062Schneider LS, Ismail MS, Dagerman K, Davis S, Olin J, McManus D, Pfeiffer E, Ryan JM, Sultzer DL, Tariot PN. Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE): Alzheimer's disease trial. Schizophr Bull. 2003;29(1):57-72. doi: 10.1093/oxfordjournals.schbul.a006991.
PubMed 12908661Schneider LS, Tariot PN, Dagerman KS, Davis SM, Hsiao JK, Ismail MS, Lebowitz BD, Lyketsos CG, Ryan JM, Stroup TS, Sultzer DL, Weintraub D, Lieberman JA; CATIE-AD Study Group. Effectiveness of atypical antipsychotic drugs in patients with Alzheimer's disease. N Engl J Med. 2006 Oct 12;355(15):1525-38. doi: 10.1056/NEJMoa061240.
PubMed 17035647Reeves S, Bertrand J, Uchida H, Yoshida K, Otani Y, Ozer M, Liu KY, Bramon E, Bies R, Pollock BG, Howard R. Towards safer risperidone prescribing in Alzheimer's disease. Br J Psychiatry. 2021 May;218(5):268-275. doi: 10.1192/bjp.2020.225.
PubMed 33176899Nagata T, Shinagawa S, Yoshida K, Noda Y, Shigeta M, Mimura M, Nakajima S. Early Improvements of Individual Symptoms With Antipsychotics Predict Subsequent Treatment Response of Neuropsychiatric Symptoms in Alzheimer's Disease: A Re-Analysis of the CATIE-AD Study. J Clin Psychiatry. 2020 Feb 11;81(2):19m12961. doi: 10.4088/JCP.19m12961.
PubMed 32074412Ozawa C, Roberts R, Yoshida K, Suzuki T, Lebowitz B, Reeves S, Howard R, Abe T, Mimura M, Uchida H. Placebo Effects in the Treatment of Noncognitive Symptoms of Alzheimer's Disease: Analysis of the CATIE-AD Data. J Clin Psychiatry. 2017 Nov/Dec;78(9):e1204-e1210. doi: 10.4088/JCP.17m11461.
PubMed 29045769Yoshida K, Roberts R, Suzuki T, Lebowitz B, Reeves S, Howard R, Abe T, Mimura M, Uchida H. Lack of Early Improvement with Antipsychotics is a Marker for Subsequent Nonresponse in Behavioral and Psychological Symptoms of Dementia: Analysis of CATIE-AD Data. Am J Geriatr Psychiatry. 2017 Jul;25(7):708-716. doi: 10.1016/j.jagp.2017.01.016. Epub 2017 Jan 30.
PubMed 28215900Miller EA, Schneider LS, Rosenheck RA. Predictors of nursing home admission among Alzheimer's disease patients with psychosis and/or agitation. Int Psychogeriatr. 2011 Feb;23(1):44-53. doi: 10.1017/S1041610210000244. Epub 2010 Mar 10.
PubMed 20214847Zheng L, Mack WJ, Dagerman KS, Hsiao JK, Lebowitz BD, Lyketsos CG, Stroup TS, Sultzer DL, Tariot PN, Vigen C, Schneider LS. Metabolic changes associated with second-generation antipsychotic use in Alzheimer's disease patients: the CATIE-AD study. Am J Psychiatry. 2009 May;166(5):583-90. doi: 10.1176/appi.ajp.2008.08081218. Epub 2009 Apr 15.
PubMed 19369318Sultzer DL, Davis SM, Tariot PN, Dagerman KS, Lebowitz BD, Lyketsos CG, Rosenheck RA, Hsiao JK, Lieberman JA, Schneider LS; CATIE-AD Study Group. Clinical symptom responses to atypical antipsychotic medications in Alzheimer's disease: phase 1 outcomes from the CATIE-AD effectiveness trial. Am J Psychiatry. 2008 Jul;165(7):844-54. doi: 10.1176/appi.ajp.2008.07111779. Epub 2008 Jun 2.
PubMed 18519523Rosenheck RA, Leslie DL, Sindelar JL, Miller EA, Tariot PN, Dagerman KS, Davis SM, Lebowitz BD, Rabins P, Hsiao JK, Lieberman JA, Schneider LS; Clinical Antipsychotic Trial of Intervention Effectiveness-Alzheimer's Disease (CATIE-AD) investigators. Cost-benefit analysis of second-generation antipsychotics and placebo in a randomized trial of the treatment of psychosis and aggression in Alzheimer disease. Arch Gen Psychiatry. 2007 Nov;64(11):1259-68. doi: 10.1001/archpsyc.64.11.1259.
PubMed 17984395
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Antipsychotic Medications in Patients With Alzheimer's Disease (CATIE Alzheimer's Disease Trial)
- ClinicalTrials.gov ID
- NCT00015548
- Acronym / sponsor ID
- N01 MH090001-05
- Conditions
- Alzheimer's Disease
- Keywords
- antipsychotic treatment, Alzheimer's disease, agitation, dementia, psychosis, behavioral symptoms, hallucinations, delusions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Mar 2001
- Study completion
- Oct 2004
- First posted
- 23 Apr 2001 (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 CATIE Alzheimer's Disease Trial is part of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Project. The study is for people with Alzheimer's disease who are having trouble with their thinking or behavior. In particular, this study is trying to find out the best treatment for people who have hallucinations (seeing or hearing things that aren't there), delusions (false beliefs), or agitation. The design of the trial helps to increase the chance that participants in the study receive a medication that helps them. The study uses three medications known as atypical antipsychotics (olanzapine, quetiapine, risperidone), which are the newest medications that are currently available for treating these problems. Participants may also receive an antidepressant (citalopram). The trial lasts for 36 weeks. Participants are given a thorough evaluation at no cost to ensure that this study is appropriate. In addition, the caregiver, family member, or friend who comes with the participant will be offered an educational program about Alzheimer's disease.
Detailed description
There are four phases.
Phase I: In the initial treatment phase (Phase 1), patients will be randomized to one of the three atypical antipsychotics or placebo in the ratio 100:100:100:150 respectively. After two weeks, the investigator can move the patient to the next phase because of lack of efficacy or tolerability. At week 12, the investigator can decide whether the current medication is sufficiently optimal or it would be more beneficial to try another randomized medication.
Phase 2: Phase 2 starts when the patient is randomized to a second medication, i.e., olanzapine, quetiapine, risperidone, or citalopram. Patients will be randomized from an antipsychotic treatment to another antipsychotic treatment or citalopram in the ratio 3:3:2, or from placebo to an antipsychotic treatment or citalopram in the ratio 1:1:1:3 respectively. Therefore, 50% of patients who took placebo in Phase 1 will be randomized to an antipsychotic in Phase 2, and 50% will be randomized to citalopram in Phase 2. After the initial two weeks in Phase 2, the investigator can move the patient to the next phase, due to lack of efficacy or tolerability. After the patient has been on the Phase 2 study drug for approximately 12 weeks, the investigator can decide whether the current medication is sufficiently optimal or whether it would be more beneficial to try another randomized medication.
Phase 3: Phase 3 is randomized open-label treatment of one of the medications not previously received, i.e., olanzapine, quetiapine, risperidone, or citalopram. Treatment failures to the second treatment can be switched to a third open-label treatment. During Phase 3 patients will be maintained on their treatments openly and managed clinically until week 36.
If the investigator determines that the patient's response is not sufficiently optimal to the randomized open-label medication, then after the first two weeks of Phase 3, the investigator can prescribe another medication (of the investigator's choice) to the patient. If this occurs then patients are classed as being in the Open-Choice Phase.
Open-Choice Phase: The Open-Choice Phase can be entered at anytime during the 36-week study and directly from any of the three phases. There are four reasons a patient can enter the open choice phase:
- Withdrawal from Phase 1 or Phase 2 with the patient or surrogate decision-maker refusing to proceed to the next randomized phase;
- Withdrawal from Phase 3;
- Withdrawal from current study drug from any of the three previous phases due to antipsychotic medication no longer being required in the opinion of the investigator; or
- Withdrawal due to concomitant treatment with an exclusionary medication.
The Open-Choice Phase is designed to keep patients monitored in the trial for the 36-week duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Dementia of the Alzheimer's Type
- Ambulatory, Outpatients who have an informant living/visiting at least 8 hours/week over 3-4 days.
- Presence of delusions, hallucinations, agitation impacting functioning and requiring medication treatment
- Agitation or psychotic symptoms began after signs or symptoms of dementia
Key exclusion criteria (4 listed)
- Be benefiting from psychotropic medication, antidepressants or anticonvulsants
- Be diagnosed with schizophrenia, schizoaffective disorder, delusional disorder or mood disorder with psychotic features.
- Have severe or unstable medical illness requiring active treatment
- Have hypersensitivity or intolerance of any of the study medications
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 |
|---|---|---|
| Olanzapine | Drug | – |
| Quetiapine | Drug | – |
| Risperidone | Drug | – |
| Citalopram | 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 17 Jun 2015.
- Background: PubMed 11739062Schneider LS, Tariot PN, Lyketsos CG, Dagerman KS, Davis KL, Davis S, Hsiao JK, Jeste DV, Katz IR, Olin JT, Pollock BG, Rabins PV, Rosenheck RA, Small GW, Lebowitz B, Lieberman JA. National Institute of Mental Health Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE): Alzheimer disease trial methodology. Am J Geriatr Psychiatry. 2001 Fall;9(4):346-60.
- Background: PubMed 12908661Schneider LS, Ismail MS, Dagerman K, Davis S, Olin J, McManus D, Pfeiffer E, Ryan JM, Sultzer DL, Tariot PN. Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE): Alzheimer's disease trial. Schizophr Bull. 2003;29(1):57-72. doi: 10.1093/oxfordjournals.schbul.a006991.
- Results publication: PubMed 17035647Schneider LS, Tariot PN, Dagerman KS, Davis SM, Hsiao JK, Ismail MS, Lebowitz BD, Lyketsos CG, Ryan JM, Stroup TS, Sultzer DL, Weintraub D, Lieberman JA; CATIE-AD Study Group. Effectiveness of atypical antipsychotic drugs in patients with Alzheimer's disease. N Engl J Med. 2006 Oct 12;355(15):1525-38. doi: 10.1056/NEJMoa061240.
- Derived from this study: PubMed 33176899Reeves S, Bertrand J, Uchida H, Yoshida K, Otani Y, Ozer M, Liu KY, Bramon E, Bies R, Pollock BG, Howard R. Towards safer risperidone prescribing in Alzheimer's disease. Br J Psychiatry. 2021 May;218(5):268-275. doi: 10.1192/bjp.2020.225.
- Derived from this study: PubMed 32074412Nagata T, Shinagawa S, Yoshida K, Noda Y, Shigeta M, Mimura M, Nakajima S. Early Improvements of Individual Symptoms With Antipsychotics Predict Subsequent Treatment Response of Neuropsychiatric Symptoms in Alzheimer's Disease: A Re-Analysis of the CATIE-AD Study. J Clin Psychiatry. 2020 Feb 11;81(2):19m12961. doi: 10.4088/JCP.19m12961.
- Derived from this study: PubMed 29045769Ozawa C, Roberts R, Yoshida K, Suzuki T, Lebowitz B, Reeves S, Howard R, Abe T, Mimura M, Uchida H. Placebo Effects in the Treatment of Noncognitive Symptoms of Alzheimer's Disease: Analysis of the CATIE-AD Data. J Clin Psychiatry. 2017 Nov/Dec;78(9):e1204-e1210. doi: 10.4088/JCP.17m11461.
- Derived from this study: PubMed 28215900Yoshida K, Roberts R, Suzuki T, Lebowitz B, Reeves S, Howard R, Abe T, Mimura M, Uchida H. Lack of Early Improvement with Antipsychotics is a Marker for Subsequent Nonresponse in Behavioral and Psychological Symptoms of Dementia: Analysis of CATIE-AD Data. Am J Geriatr Psychiatry. 2017 Jul;25(7):708-716. doi: 10.1016/j.jagp.2017.01.016. Epub 2017 Jan 30.
- Derived from this study: PubMed 20214847Miller EA, Schneider LS, Rosenheck RA. Predictors of nursing home admission among Alzheimer's disease patients with psychosis and/or agitation. Int Psychogeriatr. 2011 Feb;23(1):44-53. doi: 10.1017/S1041610210000244. Epub 2010 Mar 10.
- Derived from this study: PubMed 19369318Zheng L, Mack WJ, Dagerman KS, Hsiao JK, Lebowitz BD, Lyketsos CG, Stroup TS, Sultzer DL, Tariot PN, Vigen C, Schneider LS. Metabolic changes associated with second-generation antipsychotic use in Alzheimer's disease patients: the CATIE-AD study. Am J Psychiatry. 2009 May;166(5):583-90. doi: 10.1176/appi.ajp.2008.08081218. Epub 2009 Apr 15.
- Derived from this study: PubMed 18519523Sultzer DL, Davis SM, Tariot PN, Dagerman KS, Lebowitz BD, Lyketsos CG, Rosenheck RA, Hsiao JK, Lieberman JA, Schneider LS; CATIE-AD Study Group. Clinical symptom responses to atypical antipsychotic medications in Alzheimer's disease: phase 1 outcomes from the CATIE-AD effectiveness trial. Am J Psychiatry. 2008 Jul;165(7):844-54. doi: 10.1176/appi.ajp.2008.07111779. Epub 2008 Jun 2.
- Derived from this study: PubMed 17984395Rosenheck RA, Leslie DL, Sindelar JL, Miller EA, Tariot PN, Dagerman KS, Davis SM, Lebowitz BD, Rabins P, Hsiao JK, Lieberman JA, Schneider LS; Clinical Antipsychotic Trial of Intervention Effectiveness-Alzheimer's Disease (CATIE-AD) investigators. Cost-benefit analysis of second-generation antipsychotics and placebo in a randomized trial of the treatment of psychosis and aggression in Alzheimer disease. Arch Gen Psychiatry. 2007 Nov;64(11):1259-68. doi: 10.1001/archpsyc.64.11.1259.
- More information about Alzheimer's DiseaseLink provided by the sponsor.
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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.
Lon Schneider, MD principal investigator
University of Southern California
Pierre Tariot, MD principal investigator
University of Rochester
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olanzapine, Quetiapine and Risperidone in people with Alzheimer's Disease, run by National Institute of Mental Health (NIMH) at 34 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 4 inclusion and 4 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 17 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 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.
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 NCT00015548, which also lists 11 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 17 Jun 2015.