Ignite Creation Date:
2024-05-06 @ 1:32 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01832350
Status:
TERMINATED
Last Update Posted:
2019-10-29
First Post:
2013-04-09
Brief Title:
Nuedexta in the Treatment of Pseudobulbar Affect in Patients With Alzheimers Disease
Sponsor:
St Josephs Hospital and Medical Center Phoenix
Organization:
St Josephs Hospital and Medical Center Phoenix
Study Overview
Official Title:
Clinical Protocol of a Prospective Open-label Study to Assess the Safety and Efficacy of Nuedexta DextromethorphanQuinidine in the Treatment of Pseudobulbar Affect PBA in Patients With Alzheimers Disease
Status:
TERMINATED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decided to stop study early
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to test the hypothesis that Nuedexta 2010 administered orally will reduce Pseudobulbar Affect PBA frequency and severity CNS-Lability Scale and PLACS with satisfactory safety and high tolerability in patients with Alzheimers Disease AD The primary objective will be evaluated using a study endpoint at 1 13 26 weeks after initiation of treatment The secondary objective of this study is to evaluate the benefit of treatment with Nuedexta 2010 on cognition and functionality as demonstrated in the Rey Auditory Verbal Learning Test RAVLT Trail making A and B Wechsler Memory Scale WMS logical memory and delayed recall Controlled Oral Word Association COWA Clinical Dementia Rating CDR Neuropsychiatric Inventory NPI Alzheimers Disease Cooperative Study Activities of Daily Living Inventory ADCSADL and the 11-item Alzheimers Disease Assessment Scale-Cognitive subscore ADAS-Cog11
Detailed Description:
None
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