NCT01832350

Nuedexta in the Treatment of Pseudobulbar Affect in Patients With Alzheimer's Disease

Clinical Protocol of a Prospective, Open-label Study to Assess the Safety and Efficacy of Nuedexta (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect (PBA) in Patients With Alzheimer's Disease

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: St. Joseph's Hospital and Medical Center, Phoenix · Academic / Other
• Sex: All
• Age: 55 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to test the hypothesis that Nuedexta (20/10) administered orally will reduce Pseudobulbar Affect (PBA) frequency and severity (CNS-Lability Scale and PLACS), with satisfactory safety and high tolerability in patients with Alzheimer's 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 (20/10) 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), Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCSADL) and the 11-item Alzheimer's Disease Assessment Scale-Cognitive subscore (ADAS-Cog11).

Conditions

• Alzheimer's Disease
• Pseudobulbar Affect (PBA)

Interventions

Type	Name	Description
DRUG	Nuedexta (20/10)	Drug: Nuedexta (20/10) administered orally, two times a day, every 12 hours, during a 26-week period.

Timeline

• Start date: 2012-08-28
• Primary completion: 2015-12-01
• Completion: 2016-12-01
• First posted: 2013-04-16
• Last updated: 2019-10-29

Locations

1 site across 1 country: United States