Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00417482
Status:
COMPLETED
Last Update Posted:
2013-04-24
First Post:
2006-12-28
Brief Title:
Antipsychotic Discontinuation in Alzheimers Disease
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Antipsychotic Discontinuation in Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2013-03
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:
ADAD
Brief Summary:
In patients with Alzheimers disease AD who respond to antipsychotic treatment of psychosis andor agitationaggression the relapse risk after discontinuation is not established AD patients with psychosis andor agitationaggression receive 16 weeks of open risperidone treatment Phase A Responders are then randomized double-blind to one of three arms in Phase B 1 continuation risperidone for 32 weeks 2 risperidone for 16 weeks followed by placebo for 16 weeks 3 placebo for 32 weeks The primary outcome is time to relapse of psychosisagitation
Detailed Description:
This multicenter study 6 academic sites and 2 non-academic sites involves treating AD patients assisted living or nursing home patients and outpatients using an atypical antipsychotic risperidone In Phase A 180 AD patients with psychosis andor agitationaggression receive open treatment with risperidone for 16 weeks Responders are randomized double-blind to one of three arms in Phase B 1 continuation risperidone for the next 32 weeks 2 risperidone for the next 16 weeks followed by placebo for 16 weeks or 3 placebo for the next 32 weeks The primary hypothesis is that in the first 16 weeks of Phase B relapse risk will be lower with continuation risperidone Arms 1 2 compared to discontinuation on placebo Arm 3 The secondary hypothesis is that in the second 16 weeks of Phase B relapse risk will be lower with continuation risperidone Arm 1 compared to discontinuation on placebo Arm 2 For both randomized time periods the proportions who relapse will be compared for interpretive support This design provides useful data on the efficacy and side effects of longer term treatment with risperidone and in particular critical information about the time to relapse and likelihood of relapse in patients switched from risperidone to placebo This information is essential to guide the clinician toward optimal use of such medications in one of the most challenging types of patients the AD patient with psychosis andor agitationaggression The results of this study will also help to address Federal regulations urging early antipsychotic discontinuation in nursing homes
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 |
|---|---|---|---|
| 5R01AG021488 | NIH | None | httpsreporternihgovquickSearch5R01AG021488 |