Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043849
Status:
COMPLETED
Last Update Posted:
2009-12-11
First Post:
2002-08-14
Brief Title:
Treatment of AgitationPsychosis in DementiaParkinsonism TAPDAP
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
Treatment of AgitationPsychosis in DementiaParkinsonism TAPDAP
Status:
COMPLETED
Status Verified Date:
2006-08
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 primary aim of this study is to determine the safety and efficacy of quetiapine Seroquel for the treatment of psychosis andor agitation in patients with primary dementia complicated by coexistent parkinsonism or patients with Parkinsons 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 andor 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 Alzheimers disease AD or probable dementia with Lewy bodies DLB and coexisting parkinsonism or Parkinsons 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
This is a multicenter double-blind controlled clinical trial in which 60 subjects with a primary dementia probable Alzheimers disease AD or probable dementia with Lewy bodies DLB and coexisting parkinsonism or Parkinsons 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 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