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

Exclusion Criteria

• •Has current serious or unstable illnesses that, in investigator's opinion, could interfere with analysis of safety and efficacy data; has life expectancy \<2 years.
• •No reliable caregiver in frequent contact with patient (at least 10 hours/week.
• •Current or prior history of major psychiatric disturbance.
• •Have been in other clinical study within 30 days of entry.
• •Score of 20 or higher in Beck Depression Inventory.
• •Multiple episodes of head trauma, history within last year of serious infectious disease affecting the brain, head trauma resulting in protracted loss of consciousness, or myasthenia gravis.
• •Within the last 5 years, history of a primary or recurrent malignant disease.
• •Known sensitivity to quinidine or dextromethorphan.
• •History of human immunodeficiency virus, multiple or severe drug allergies, or severe post-treatment hypersensitivity reactions.
• •History of chronic alcohol or drug abuse/dependence within the past 5 years.
• •Judged by investigator to be at serious risk for suicide.
• •Has a recent or current lab result indicating clinically significant lab abnormality.
• •At Visit 1 has ALT/SGPT values ≥2 times upper limit of normal (ULN); AST/SGOT values ≥3 times the ULN; total bilirubin values ≥2 times the ULN.
• •Resting diurnal oxygen saturation \<95%.
• •Received dextromethorphan and quinidine within previous 6 months.
• •Hypotension (systolic BP \<100 mm Hg); postural syncope; unexplained syncope.
• •Used medications that affect the CNS (except for AD) for less than 4 weeks.
• •On disallowed concomitant medications.
• •Experiencing acute exacerbation of underlying neurological disorder within previous 2 months.