Institutes of Wellness grant CA131582 to D.W.S., an institutional
Institutes of Well being grant CA131582 to D.W.S., an institutional grant towards the Wistar Institute (NCI Cancer Core Grant CA010815), as well as the Reproductive Scientist Improvement System (NIH grant 5K12HD00849). We gratefully acknowledge the usage of the Wistar Institute Proteomics Core Facility and Dr. Dionyssios CB2 Antagonist Synonyms Katsaros, University of Turin, Turin, Italy, for delivering patient serum specimens. We gratefully acknowledge the administrative assistance of Mea Fuller.NIH-PA Author Manuscript NIH-PA Author Manuscript NIH-PA Author Manuscript
Shah et al. Alzheimer’s Analysis Therapy 2013, 5:59 alzres.com/content/5/6/RESEARCHOpen AccessThe S-Connect study: results from a randomized, controlled trial of Souvenaid in mild-to-moderate Alzheimer’s diseaseRaj C Shah1*, Patrick J Kamphuis2, Sue Leurgans1, Sophie H Swinkels2,three, Carl H Sadowsky4, Anke Bongers2, Stephen A Rappaport5, Joseph F Quinn6, Rico L Wieggers2, Philip Scheltens7 and David A BennettAbstractIntroduction: Souvenaidcontaining FortasynConnect is often a medical meals made to support synapse synthesis in persons with Alzheimer’s disease (AD). Fortasyn Connect involves precursors (uridine monophosphate; choline; phospholipids; eicosapentaenoic acid; docosahexaenoic acid) and cofactors (vitamins E, C, B12, and B6; folic acid; selenium) for the formation of neuronal membranes. Irrespective of whether Souvenaid slows cognitive decline in treated persons with mild-to-moderate AD has not been addressed. Procedures: Inside a 24-week, double-masked clinical trial at 48 clinical centers, 527 participants taking AD drugs [52 ladies, mean age 76.7 years (Typical Deviation, SD = eight.two), and imply Mini-Mental State Examination score 19.five (SD = 3.1, variety 144)] have been randomized 1:1 to each day, 125-mL (125 kcal), oral intake of the active product (Souvenaid) or an iso-caloric manage. The key outcome of cognition was assessed by the 11-item Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-cog). Compliance was calculated from every day diary recordings of product intake. Statistical analyses had been performed working with mixed models for repeated measures. Results: Cognitive overall performance as assessed by ADAS-cog showed decline over time in both handle and active study groups, with no considerable difference in between study groups (distinction =0.37 points, Regular Error, SE = 0.57, p = 0.513). No group differences in adverse occasion rates were found and no clinically relevant differences in blood safety parameters were noted. All round compliance was higher (94.1 [active] and 94.five [control]), which was confirmed by considerable alterations in blood (nutritional) biomarkers. Conclusions: Add-on intake of Souvenaid through 24 weeks did not slow cognitive decline in persons treated for mild-to-moderate AD. Souvenaid was well tolerated in combination with standard care AD medicines. Trial registration: Dutch Trial Register quantity: NTR1683.Introduction By 2050 the amount of people living with dementia due to Alzheimer’s disease (AD) worldwide is estimated to boost from 36 million to 115 million people [1], with two-thirds of persons affected living in creating countries. Given the worldwide public well being effect of AD, enhanced Estrogen receptor Inhibitor Formulation efforts are needed to develop novel and productive AD interventions which are effortless to deploy and aren’t resource intensive. AD is often a neurodegenerative condition* Correspondence: [email protected] 1 Rush Alzheimer’s Disease Center, Rush University Healthcare Center, 600 South Paulina, Suite 1022, Chicago, IL 60612.