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

Launched by ST. JOSEPH'S HOSPITAL AND MEDICAL CENTER, PHOENIX · Apr 15, 2013

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Eligibility criteria

• Inclusion Criteria:
• • Male/female 55 to 90 years, inclusive.
• • Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association criteria for probable AD.
• • Modified Hachinski Ischemia Scale score of ≤4.
• • Folstein Mini Mental State Exam score 16-26 at Visit 1.
• • Geriatric Depression Scale score ≤6. For patient with history of depression, he/she have been on steady dose of anti-depressant for at least 3 months.
• • Clinical history and relevant symptoms of Pseudobulbar Affect.
• • Center for Neurologic Study-Lability Scale score at baseline ≥13.
• • Stable hematologic, hepatic, and renal function, with no clinically significant symptoms, and with clinical laboratory results (CBC, clinical chemistry, and urinalysis) up to 1-fold higher than upper limit of normal range.
• • Resting respiratory rate 12-20/minute.
• • MRI or CT scan within past 12 months; no findings inconsistent with diagnosis of AD.
• • ECG (within 4 weeks prior to entry)with no evidence of clinically significant abnormalities.
• • Concurrent treatment with an acetylcholinesterase inhibitor or memantine allowed; must be on stable dose at least 2 months before screening. Dosing must remain stable throughout the study.
• • Use of SSRI's allowed. Must have used for 3 months prior to study entry; dose must remain unchanged during course of study.
• • No current symptoms of depressive disorder.
• • Score of 19 or lower in the Beck Depression Inventory.
• • Agrees to use no prohibited medications during study.
• 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.