TY - JOUR
T1 - The S-Connect study
T2 - Results from a randomized, controlled trial of Souvenaid in mild-to-moderate Alzheimer's disease
AU - Shah, Raj C.
AU - Kamphuis, Patrick J.
AU - Leurgans, Sue
AU - Swinkels, Sophie H.
AU - Sadowsky, Carl H.
AU - Bongers, Anke
AU - Rappaport, Stephen A.
AU - Quinn, Joseph F.
AU - Wieggers, Rico L.
AU - Scheltens, Philip
AU - Bennett, David A.
N1 - Funding Information:
Study design and planning were carried out in conjunction with the sponsor, Nutricia Research, on behalf of Nutricia Advanced Medical Nutrition. The sponsor also provided the study products and funding for the research, data collection and analysis. The corresponding author had final responsibility for the decision to submit for publication. RCS serves on the Board of Directors of the Alzheimer’s Association – Greater Illinois Chapter; serves as a member of the Investigator Consultation Network for Merck Research Laboratories; served on a research advisory panel for Accera, Inc., and a clinical advisory panel for Nutricia, Inc.; receives or recently received research support as Site Principal Investigator or Site Subinvestigator from Ceregene, Inc., Eisai, Inc., Eli Lilly, Inc., Elan Pharmaceuticals, Inc., Genentech, Inc., Merck & Co., Inc., Metabolic Solutions Development Company, Pamlab, L.L.C., and Pfizer, Inc.; and receives research support from the National Institutes of Health (NIH) (P30 AG101061 (Education and Information Transfer Core Leader), U01 AG010483 (Site Investigator), U01AG024904 (Site Co-investigator), U01 AG029824 (Coinvestigator), and P20MD006886 (Community Outreach/ Engagement Core Co-Leader), and from the Illinois Department of Public Health Alzheimer’s Disease Assistance Center. SL reports no financial disclosures relevant to this work. DAB receives research support from the National Institutes of Health, the State of Illinois Excellence in Academic Medicine Act, and Nutricia, Inc.; and has served as a consultant for Nutricia, Inc., Eli Lilly, Inc., and Enzymotic, Ltd. CHS serves on the advisory board and speaker’s bureaus for Novartis International AG, Eli Lilly, Inc., Forest Pharmaceuticals, Inc., and Accera, Inc. JQ receives research support from the NIH(P30 AG008017). SAR serves on the Medical and Scientific Advisory Board of the Alzheimer’s Association – Greater Indiana Chapter and reports no financial disclosures relevant to this work. PS is employed by VU University Medical Center, Amsterdam, which received unrestricted funding from Nutricia Research in the past. PJK, RLW, SHS and AB are employees of Nutricia Research. PS is co-Editor-in-Chief of Alzheimer’s Research & Therapy and receives an annual honorarium for the Alzheimer Center at the VU University Medical Center, Amsterdam.
PY - 2013/11/26
Y1 - 2013/11/26
N2 - 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.
AB - 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.
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U2 - 10.1186/alzrt224
DO - 10.1186/alzrt224
M3 - Article
AN - SCOPUS:84891795217
SN - 1758-9193
VL - 5
JO - Alzheimer's Research and Therapy
JF - Alzheimer's Research and Therapy
IS - 6
M1 - 59
ER -