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
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).
Indication: Alzheimer's Disease
Modality: small molecule
Target: Nuedexta (20/10)
Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Source URL: ClinicalTrials.gov
Source updated: Oct 29, 2019
Ingested: Jun 08, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by target_normalized: Nuedexta (20/10)
View original source fields
Condition raw: Alzheimer's Disease, Pseudobulbar Affect (PBA)
Condition normalized: Alzheimer's Disease, Pseudobulbar Affect (PBA)
Modality raw: small molecule
Modality normalized: small molecule
Target raw: Nuedexta (20/10)
Target normalized: Nuedexta (20/10)