Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00015548
Status:
COMPLETED
Last Update Posted:
2015-06-17
First Post:
2001-04-20
Brief Title:
CATIE-Alzheimers Disease Trial
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institute of Mental Health NIMH
Study Overview
Official Title:
Comparative Effectiveness of Antipsychotic Medications in Patients With Alzheimers Disease CATIE Alzheimers Disease Trial
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The CATIE Alzheimers Disease Trial is part of the Clinical Antipsychotic Trials of Intervention Effectiveness CATIE Project The study is for people with Alzheimers 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 arent 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 Alzheimers 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 100100100150 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 ie olanzapine quetiapine risperidone or citalopram Patients will be randomized from an antipsychotic treatment to another antipsychotic treatment or citalopram in the ratio 332 or from placebo to an antipsychotic treatment or citalopram in the ratio 1113 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 ie 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 patients 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 investigators 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
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 100100100150 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 ie olanzapine quetiapine risperidone or citalopram Patients will be randomized from an antipsychotic treatment to another antipsychotic treatment or citalopram in the ratio 332 or from placebo to an antipsychotic treatment or citalopram in the ratio 1113 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 ie 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 patients 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 investigators 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01 MH90001-AD | None | None | None |
| DSIR AT | None | None | None |