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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...
Using a wearable technology (PKG) (Personal Kinetograph; Global Kinetics, Portsmouth, NH) cleared by the Food and Drug Administration (FDA), over 40,000 reports from individuals with Parkinson’s disease (PD) have been recorded and used by more than 200 Parkinson’s care centers. The PKG provides objective ambulatory measures of PD symptoms, including bradykinesia, dyskinesia, and tremor. Analysis of baseline data from the PKG showed that 54% of people reporting clinical measures with PKG had uncontrolled but likely treatable bradykinesia and 10% had uncontrolled, but likely...
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
Gordon H. Baltuch, MD, PhD
Charisse Litchman, MD, FAHS; and Sirisha Sanamandra, MBBS