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From Framingham to Facebook: the contagion of controversy

April 1, 2015

…RB) approval (Kramer et al. PNAS USA 2014;111:8788-8790; free full text at www.pnas.org/content/111/24/8788.full.pdf). Facebook has argued that users agree to the company’s data use policy when they sign up, which constitutes informed consent. Cornell has stated that its IRB ruled that the project was not subject to the university’s Human Research Protection Program. PNAS USA normally adheres to the Health and Human Services Policy for the Protect…

Optimizing patient assessment in MS: NEDA and beyond

March 12, 2015

…study has examined the value of NEDA in predicting long-term disability outcomes. In a seven-year follow-up of patients in the Comprehensive Longitudinal Investigation of MS at the Brigham and Women’s Hospital (CLIMB) study, the positive predictive value (PPV) of NEDA for no significant progression (defined as EDSS change < 0.5) was 71.7% at one year, and 78.3% at two years (Rotstein et al. ECTRIMS 2014; abstract P763). The PPV was improved somewh…

Relapse prevention in first-episode schizophrenia: role of long-acting injectables

January 14, 2015

…Clin Psychiatry 2014; epublished August 19, 2014; free full text at http://www.psychiatrist.com/jcp/article/Pages/2014/v75n11/v75n1107.aspx [requires registration]). A total of 304 patients were randomized to aripiprazole OM 400 mg or placebo for 12 weeks. All subjects received concomitant oral aripiprazole 10-20 mg/day for 14 days. A significant treatment effect was seen at week 1, and this benefit was maintained at all time points throughout the…

Serotonergic mechanisms in PD: two reports

December 10, 2014

…sis were randomized to pimavanserin 40 mg/day or placebo for six weeks. Concomitant antipsychotic use was not permitted. The primary outcome was change from baseline in the PD-adapted Scale for Assessment of Positive Symptoms (SAPS-PD). Pimavanserin was associated with a greater decrease in SAPS-PD scores compared to placebo (-5.79 vs. -2.73). Pimavanserin was generally well tolerated. Sleep was also improved with the drug. Ten of 95 patients (10….

Future uncertain for active immunotherapies in AD – Part 1

December 10, 2014

…ounced in July 2014 in subjects at risk of developing AD (media release at www.novartis.com/newsroom/media-releases/en/2014/1824651.shtml). To date, BACE1 inhibitors have had a mixed track record. A phase II trial of LY2886721 was terminated due to hepatotoxicity, although it is unclear if liver effects were related to its anti-BACE effects (Lahiri et al. Alzheimers Dement 2014;10(5 Suppl):S411-419). Development of RG7129 has been stopped. However…