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The S-Connect study: results from a randomized, controlled trial of Souvenaid in mild-to-moderate Alzheimer’s disease

Introduction Souvenaid® containing Fortasyn® Connect is a medical food designed to support synapse synthesis in persons with Alzheimer’s disease (AD). Fortasyn Conne ct includes precursors (uridine monophosphate; choline; phospholipids; eicosopentaenoic acid; docosahexaenoic acid) and cofactors (vitamins E, C, B12, and B6; folic acid; seleni um) for the formation of neuronal membranes. Whether Souvenaid slows cognitive decline in treate d persons with mild-to-moderate AD has not been addressed. Methods In a 24-week, double-masked clinical trial at 48 clinical centers, 527 participants taking AD medications [52% women, mean age 76.7 years (Standard Deviation, SD = 8.2) , and mean Mini-Mental State Examination score 19.5 (SD = 3.1, range 14–24)] were randomized 1:1 to daily, 125-mL (125 kcal), oral intake of the active product (Souvenaid) or an iso-caloric control. The primary outcome of cognition was assessed by the 11-ite m Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-cog). Compliance w as calculated from daily diary recordings of product intake. Statistical analyses were performed using mixed models for repeated measures. Results Cognitive performance as assessed by ADAS-cog showed decli ne over time in both control and active study groups, with no significant difference between stud y groups (difference =0.37 points, Standard Error, SE = 0.57, p = 0.513). No group differences in adverse event rates were found and no clinically relevant differences in blood safe ty parameters were noted. Overall compliance was high (94.1% [active] and 94.5% [control]), whic h was confirmed by significant changes in blood (nutritional) biomarkers. Conclusions Add-on intake of Souvenaid during 24 weeks did not slow cognitive decline in pe rsons treated for mild-to-moderate AD. Souvenaid was well tolerated in c ombination with standard care AD medications.

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The Role of Biomarkers in Clinical Trials for Alzheimer Disease

Biomarkers are likely to be important in the study of Alzheimer disease (AD) for a variety of reasons. A clinical diagnosis of Alzheimer disease is inaccurate even among experienced investigators in about 10% to 15% of cases, and biomarkers might improve the accuracy of diagnosis. Importantly for the development of putative disease-modifying drugs for Alzheimer disease, biomarkers might also serve as indirect measures of disease severity. When used in this way, sample sizes of clinical trials might be reduced, and a change in biomarker could be considered supporting evidence of disease modification. This review summarizes a meeting of the Alzheimer’s Association’s Research Roundtable, during which existing and emerging biomarkers for AD were evaluated. Imaging biomarkers including volumetric magnetic resonance imaging and positron emission tomography assessing either glucose utilization or ligands binding to amyloid plaque are discussed. Additionally, biochemical biomarkers in blood or cerebrospinal fluid are assessed. Currently appropriate uses of biomarkers in the study of Alzheimer disease, and areas where additional work is needed, are discussed.

Reference: Thal LJ, Kantarci K, Reiman EM, Klunk WE, Weiner MW, Zetterberg H, Galasko D, Praticò D, Griffin S, Schenk D, Siemers E. The role of biomarkers in clinical trials for Alzheimer disease. Alzheimer Dis Assoc Disord. 2006;20(1):6-15