title: The S-Connect study: results from a randomized, controlled trial of Souvenaid in mild-to-moderate Alzheimer's disease.
abstract: BACKGROUND
  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.
  
  
  BACKGROUND
  DUTCH TRIAL REGISTER NUMBER: NTR1683.
authors.affiliation: Rush Alzheimer's Disease Center, Rush University Medical Center, 600 South Paulina, Suite 1022, Chicago, IL 60612, USA.
authors.forename: Raj C
authors.initials: RC
authors.lastname: Shah
authors.affiliation: Nutricia Advanced Medical Nutrition, Nutricia Research, Uppsalalaan 12, PO Box 80141, 3584TC, Utrecht, the Netherlands.
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Kamphuis
authors.affiliation: Rush Alzheimer's Disease Center, Rush University Medical Center, 600 South Paulina, Suite 1022, Chicago, IL 60612, USA.
authors.forename: Sue
authors.initials: S
authors.lastname: Leurgans
authors.affiliation: Nutricia Advanced Medical Nutrition, Nutricia Research, Uppsalalaan 12, PO Box 80141, 3584TC, Utrecht, the Netherlands ; Nutricia Research, Uppsalalaan 12, PO Box 80141, 3584TC, Utrecht, the Netherlands.
authors.forename: Sophie H
authors.initials: SH
authors.lastname: Swinkels
authors.affiliation: Department of Neurology, Nova Southeastern University, 33407 North Congress Avenue, West Palm Beach FL, USA.
authors.forename: Carl H
authors.initials: CH
authors.lastname: Sadowsky
authors.affiliation: Nutricia Advanced Medical Nutrition, Nutricia Research, Uppsalalaan 12, PO Box 80141, 3584TC, Utrecht, the Netherlands.
authors.forename: Anke
authors.initials: A
authors.lastname: Bongers
authors.affiliation: Agewell Health®, 46260 North Meridian Street, Indianapolis IN, USA.
authors.forename: Stephen A
authors.initials: SA
authors.lastname: Rappaport
authors.affiliation: Department of Neurology, Oregon Health and Science University and the Portland VA Medical Center, 3181 Sw Sam Jackson Park Road, Portland OR, USA.
authors.forename: Joseph F
authors.initials: JF
authors.lastname: Quinn
authors.affiliation: Nutricia Advanced Medical Nutrition, Nutricia Research, Uppsalalaan 12, PO Box 80141, 3584TC, Utrecht, the Netherlands.
authors.forename: Rico L
authors.initials: RL
authors.lastname: Wieggers
authors.affiliation: Alzheimer Center, VU University Medical Center, PO Box 7057, 1007MB, Amsterdam, the Netherlands.
authors.forename: Philip
authors.initials: P
authors.lastname: Scheltens
authors.affiliation: Rush Alzheimer's Disease Center, Rush University Medical Center, 600 South Paulina, Suite 1022, Chicago, IL 60612, USA.
authors.forename: David A
authors.initials: DA
authors.lastname: Bennett