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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...
Over 7,500 individuals have been or are being treated with nusinersen (Spinraza; Biogen, Cambridge, MA). Across clinical trials and the real-world setting, there are now 7 years of data and experience showing that nusinersen has clinical efficacy and safety. In the NURTURE study (NCT02386553) in which presymptomatic infants likely to develop spinal muscular atrophy type one (SMA1) or type 2 (SMA2) were treated with nusinersen, children continue to develop and gain typical motor milestones. After 26 months of treatment, all infants could sit without support; 88% could walk with support and 77%...
The Food and Drug Administration (FDA) has scheduled an end-of-phase 2 clinical trial meeting for a sublingual formulation of racemic ketamine (Wafermine; iX Biopharma, Singapore) for treatment of moderate-to-severe acute pain. The therapy contains R and S isomers of ketamine in equal proportions In a phase 2b randomized placebo-controlled study (NCT03246971) participants experienced analgesic efficacy from ketamine with safety and tolerability for treatment of acute post-operative pain after abdominoplasty or bunionectomy. In pharmacokinetic studies (NCT01377831),...
Cynthia E. Armand, MD; Alina Masters-Israilov, MD; and Richard B. Lipton, MD
Umer Najib, MD, FAHS; Jessica Frey, MD; and David B. Watson, MD, FAHS, FAAN
Ronald Devere, MD, FAAN