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

Raj C. Shah, Patrick J. Kamphuis, Sue Leurgans, Sophie H. Swinkels, Carl H. Sadowsky, Anke Bongers, Stephen A. Rappaport, Joseph F. Quinn, Rico L. Wieggers, Philip Scheltens, David A. Bennett

Research output: Contribution to journalArticle

64 Scopus citations

Abstract

Introduction. Souvenaid® containing Fortasyn® Connect is a medical food designed to support synapse synthesis in persons with Alzheimer's disease (AD). Fortasyn Connect includes 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. Whether Souvenaid slows cognitive decline in treated 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-item Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog). Compliance was 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 decline over time in both control and active study groups, with no significant difference between study 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 safety parameters were noted. Overall compliance was high (94.1% [active] and 94.5% [control]), which was confirmed by significant changes in blood (nutritional) biomarkers. Conclusions: Add-on intake of Souvenaid during 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 medications. Trial registration. Dutch Trial Register number: NTR1683.

Original languageEnglish (US)
Article number59
JournalAlzheimer's Research and Therapy
Volume5
Issue number6
DOIs
StatePublished - Nov 26 2013

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology
  • Cognitive Neuroscience

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    Shah, R. C., Kamphuis, P. J., Leurgans, S., Swinkels, S. H., Sadowsky, C. H., Bongers, A., Rappaport, S. A., Quinn, J. F., Wieggers, R. L., Scheltens, P., & Bennett, D. A. (2013). The S-Connect study: Results from a randomized, controlled trial of Souvenaid in mild-to-moderate Alzheimer's disease. Alzheimer's Research and Therapy, 5(6), [59]. https://doi.org/10.1186/alzrt224