Diseases & Diagnoses
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The National Institute on Aging (NIA) has provided a 4-year grant for a phase 2 study of T3D-959 (T3D Therapeutics, Research Triangle Park, NC), a novel, metabolic-focused treatment for Alzheimer’s disease (AD). The PIONEER study, which will begin patient dosing in early 2020, is a double-blind placebo-controlled efficacy and safety study that will enroll up to 252 adults with mild-to-moderate AD. Participants in the study will receive 1 of 3 different oral doses of T3D-959 or placebo for 24 weeks. In a phase 2a study (NCT02560753), 34 participants with...
In a phase 2b/3 clinical trial (NCT02848326), adults treated with atogepant (Allergan, Madison, NJ) had greater reduction from baseline in monthly migraine days (MMD) on average, compared with those treated with placebo. No serious adverse events related to treatment occurred. Of those treated with atogepant, the frequency of treatment-emergent adverse events ranged from 57% to 66% across the treatment arms vs 49.5% for those who took placebo. Elevated ALT or AST (>3x the upper limit of normal) occurred in 10 participants (1.8%), balanced across the 6 treatment arms, including...
The Food and Drug Administration (FDA) has approved amifampridine (Ruzurgi; Jacobus Pharmaceutical Company, Princeton, NJ) for treating Lambert-Eaton myasthenic syndrome (LEMS) in patients age 6 to 17 years. This is the first FDA approval of a therapy specifically for pediatric patients with LEMS, a rare autoimmune neuromuscular junction disorder. Use of amifampridine in pediatric patients is supported by clinical studies in adults with LEMS, pharmacokinetic data in adult patients, pharmacokinetic modeling and simulation to identify the dosing regimen in pediatric...
Katharine Nicholson, MD
Lauren Doyle Strauss, DO, FAHS; and Scott Otallah, MD
Aniket Natekar, MD, MSc; Malya Sahu, BSc; Hsiangkuo Yuan, MD, PhD; and Stephanie Nahas, MD, MSEd, FAHS, FAAAN