Nuedexta for Treating Pseudobulbar Affect in Alzheimer's Disease
Active, not recruiting
Nuedexta (dextromethorphan/quinidine) is an approved treatment for pseudobulbar affect (PBA), a neurological disorder characterized by sudden, unpredictable episodes of crying and/or laughing. These episodes are uncontrolled, exaggerated, or different from a person's true feelings. PBA occurs in people with neurological diseases and conditions such as Alzheimer's, brain injury, or stroke. In this trial, investigators will test Nuedexta in people with Alzheimer's disease to see if if can reduce the number and severity of PBA episodes.
|Minimum Age||Maximum Age||Gender||Healthy Volunteers|
|55 Years||90 Years||Both||No|
- Probable Alzheimer's disease, as defined by criteria of the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association
- Modified Hachinski Ischemia Scale score of ≤4; Mini Mental State Examination score of 16-26; Geriatric Depression Scale score of ≤6
- Clinical history and symptoms of pseudobulbar affect
- No current symptoms of depressive disorder; participants with history of depression may have been on steady dose of antidepressant for at least 3 months and remain on stable dose throughout the study
- Stable hematologic, hepatic, and renal function, with no clinically significant symptoms and with laboratory results up to one-fold higher than upper limit of normal range
- Resting respiratory rate of 12-20 per minute
- MRI or CT scan findings consistent with a diagnosis of Alzheimer's within the past 12 months
- Electrocardiogram within 4 weeks prior to entry, with no evidence of clinically significant abnormalities
- If taking acetylcholinesterase inhibitor or memantine, must have been on stable dose for at least 2 months before screening
- Reliable caregiver in frequent contact with patient (at least 10 hours per week)
- Current serious or unstable illnesses that, in the investigator's opinion, could interfere with analysis of safety and efficacy data; life expectancy of less than 2 years
- Current or prior history of major psychiatric disturbance; history of chronic alcohol or drug abuse/dependence within the past 5 years; at serious risk of suicide
- Participation in another clinical study within the past 30 days
- Multiple episodes of head trauma; history within the past year of serious infectious disease affecting the brain, head trauma resulting in protracted loss of consciousness, or myasthenia gravis
- History within the past 5 years of malignant disease
- Known sensitivity to quinidine or dextromethorphan or received Nuedexta within the past 6 months
- History of human immunodeficiency virus, multiple or severe drug allergies, or severe post-treatment hypersensitivity reactions
- Recent or current lab result indicating clinically significant lab abnormality
- Hypotension (systolic blood pressure of <100 mm Hg); postural or unexplained fainting
- Use of medications for less than 4 weeks that affect the central nervous system (except for Alzheimer's medications)
- Acute exacerbation of underlying neurological disorder within the past 2 months
Nuedexta (dextromethorphan/quinidine) is an approved treatment for pseudobulbar affect (PBA), a neurological disorder characterized by sudden, unpredictable episodes of crying and/or laughing. These episodes are uncontrolled, exaggerated, or different from a person's true feelings. PBA occurs in people with neurological diseases and conditions such as Alzheimer's, brain injury, or stroke. In this Phase IV trial, participants with mild to moderate Alzheimers disease and pseudobulbar affect will take the approved drug Neudexta to see if it can alleviate PBA. The objective is to evaluate the benefit of treatment on PBA as well as on cognition and functionality, as demonstrated by performance on several neuropsychological tests.
Barrow Neurological Institute
St. Joseph's Hospital and Medical Center
- Avanir Pharmaceuticals
|Jiong Shi, MD, PhD||Principal Investigator||Barrow Neurological Institute, St. Joseph's Hospital and Medical Center|
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
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