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Alzheimers Res Ther. 2013 Nov 26;5(6):59. doi: 10.1186/alzrt224. eCollection 2013.

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

Author information

1
Rush Alzheimer's Disease Center, Rush University Medical Center, 600 South Paulina, Suite 1022, Chicago, IL 60612, USA.
2
Nutricia Advanced Medical Nutrition, Nutricia Research, Uppsalalaan 12, PO Box 80141, 3584TC, Utrecht, the Netherlands.
3
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.
4
Department of Neurology, Nova Southeastern University, 33407 North Congress Avenue, West Palm Beach FL, USA.
5
Agewell Health®, 46260 North Meridian Street, Indianapolis IN, USA.
6
Department of Neurology, Oregon Health and Science University and the Portland VA Medical Center, 3181 Sw Sam Jackson Park Road, Portland OR, USA.
7
Alzheimer Center, VU University Medical Center, PO Box 7057, 1007MB, Amsterdam, the Netherlands.

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.

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