Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009217
Status:
COMPLETED
Last Update Posted:
2016-05-24
First Post:
2001-01-23
Brief Title:
Treatment of Behavioral Symptoms in Alzheimers Disease
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Treatment of Behavioral Symptoms in Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2012-02
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 optimal strategy for the treatment of behavioral complications in patients with probable Alzheimers disease AD remains unclear
The objective of this study is to evaluate the risk of relapse following discontinuation of haloperidol in patients with Alzheimers disease AD with psychosis or agitation who respond to it
In Phase A of this study AD outpatients with behavioral complications receive 20 weeks of open haloperidol treatment with an oral dose of 1-5 mg daily titrated individually to achieve the optimal trade-off between efficacy and side effects Responders to Phase A participate in Phase B a 24-week continuation trial in which patients are randomized to continuation haloperidol or placebo
The primary outcome is the time to relapse of psychosis or behavioral disturbance
The objective of this study is to evaluate the risk of relapse following discontinuation of haloperidol in patients with Alzheimers disease AD with psychosis or agitation who respond to it
In Phase A of this study AD outpatients with behavioral complications receive 20 weeks of open haloperidol treatment with an oral dose of 1-5 mg daily titrated individually to achieve the optimal trade-off between efficacy and side effects Responders to Phase A participate in Phase B a 24-week continuation trial in which patients are randomized to continuation haloperidol or placebo
The primary outcome is the time to relapse of psychosis or behavioral disturbance
Detailed Description:
The study involves two phases Outpatients with AD who meet inclusion exclusion criteria enter Phase A the 20 week open acute treatment phase that uses a flexible dose regimen of haloperidol 1-5 mg daily Haloperidol is started at an oral dose of 1 mg daily with subsequent dose titration in 1 mg increments until the optimal dose is reached ie optimal trade-off between efficacy and side effects At the end of Phase A patients who do not meet criteria for clinical response exit the protocol and is treated openly with alternative medications
Phase A responders enter Phase B a 24-week random assignment placebo-controlled continuation trial Randomization is stratified by the severity of dementia and by the presence of psychosis Half the patients are randomized to haloperidol continuing at the same dose as at the end of Phase A and the other half are randomized to placebo Patients who relapse during Phase B exit the protocol and receive open treatment
In Phase A patients are followed at 0 2 4 weeks and every 4 weeks thereafter until 20 weeks In the discontinuation trial Phase B patients are followed at 0 1 2 4 week time points and every 4 weeks thereafter until 24 weeks If a patient shows signs of relapse the patient is brought in for more frequent visits regardless of the stage of the protocol
Phase A responders enter Phase B a 24-week random assignment placebo-controlled continuation trial Randomization is stratified by the severity of dementia and by the presence of psychosis Half the patients are randomized to haloperidol continuing at the same dose as at the end of Phase A and the other half are randomized to placebo Patients who relapse during Phase B exit the protocol and receive open treatment
In Phase A patients are followed at 0 2 4 weeks and every 4 weeks thereafter until 20 weeks In the discontinuation trial Phase B patients are followed at 0 1 2 4 week time points and every 4 weeks thereafter until 24 weeks If a patient shows signs of relapse the patient is brought in for more frequent visits regardless of the stage of the protocol
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 |
|---|---|---|---|
| R01MH055735 | NIH | None | httpsreporternihgovquickSearchR01MH055735 |