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

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).

Timeline

Start

2012-08-28

Primary completion

2015-12-01

Completion

2016-12-01

Publications

• Background Schiffer R, Pope LE. Review of pseudobulbar affect including a novel and potential therapy. J Neuropsychiatry Clin Neurosci. 2005 Fall;17(4):447-54. doi: 10.1176/jnp.17.4.447.
• Background Green RL. Regulation of Affect. Semin Clin Neuropsychiatry. 1998 Jul;3(3):195-200.
• Background Lieberman A, Benson DF. Control of emotional expression in pseudobulbar palsy. A personal experience. Arch Neurol. 1977 Nov;34(11):717-9. doi: 10.1001/archneur.1977.00500230087017.
• Background Starkstein SE, Migliorelli R, Teson A, Petracca G, Chemerinsky E, Manes F, Leiguarda R. Prevalence and clinical correlates of pathological affective display in Alzheimer's disease. J Neurol Neurosurg Psychiatry. 1995 Jul;59(1):55-60. doi: 10.1136/jnnp.59.1.55.
• Background Tanaka M, Sumitsuji N. Electromyographic study of facial expressions during pathological laughing and crying. Electromyogr Clin Neurophysiol. 1991 Oct-Nov;31(7):399-406.
• Background Pioro EP, Brooks BR, Cummings J, Schiffer R, Thisted RA, Wynn D, Hepner A, Kaye R; Safety, Tolerability, and Efficacy Results Trial of AVP-923 in PBA Investigators. Dextromethorphan plus ultra low-dose quinidine reduces pseudobulbar affect. Ann Neurol. 2010 Nov;68(5):693-702. doi: 10.1002/ana.22093.
• Background Strowd RE, Cartwright MS, Okun MS, Haq I, Siddiqui MS. Pseudobulbar affect: prevalence and quality of life impact in movement disorders. J Neurol. 2010 Aug;257(8):1382-7. doi: 10.1007/s00415-010-5550-3. Epub 2010 Apr 8.
• Background Wolf JK, Santana HB, Thorpy M. Treatment of "emotional incontinence" with levodopa. Neurology. 1979 Oct;29(10):1435-6. doi: 10.1212/wnl.29.10.1435-b. No abstract available.

Drugs

Indications