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The Alzheimer’s Clinical Trials Consortium (ACTC) has announced 2 studies of combination therapy of elenbecestat (Eisai, Woodcliff Lake, NJ) and BAN2401(Eisai, Woodcliff Lake, NJ and BioArctic, Stockholm, Sweden) for potential prevention of Alzheimer’s disease (AD). The ACTC was formed with funding from the National Instute on Aging (NIA). In the A3 study, participants without cognitive impairment or elevated amyloid levels who are at risk for amyloid-baccumulation will be randomly assigned to receive elenbecestat alone (2 doses being tested) or placebo. Elenbecestat is...
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...
In a double-blind phase 2 study (NCT02975349), adult participants with multiple sclerosis (MS) treated with evobrutinib (75 mg taken orally once or twice daily) reduced the number of T1 gadolinium enhancing (Gd+) lesions as early as 12 weeks after initiating treatment (Table 1). This reduction in T1 Gd+ lesions was maintained through week 48 of the study (Table 2). Participants treated with evobrutinib also had reduced annualized relapse rate (ARR) compared with those treated with placebo (Table 1), although this did not reach statistical significance, possibly because of study size...
Mary Motwani, PhD; and Deena Kuruvilla, MD
Gordon H. Baltuch, MD, PhD
Katharine Nicholson, MD