The S-Connect study: results from a randomized, controlled trial of Souvenaid in mild-to-moderate Alzheimer's disease
Open accessAbstract
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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There is no compelling evidence that Souvenaid provides additional benefits in patients with AD dementia treated with anti-AD medications.
“There is no compelling evidence that Souvenaid, a prescription nutritional supplement (ie, medical food) containing Fortasyn Connect provides additional benefits in patients with AD dementia treated with anti-AD medications.129”
From The Alzheimer’s Disease Clinical Spectrum (2019) · cites this paper as [129]
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- Authors
- 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.
- Affiliations
- Rush University Medical Center (US)
- Nutricia Research (Netherlands) (NL)
- Nova Southeastern University (US)
- Oregon Health & Science University (US)
- Amsterdam UMC Location Vrije Universiteit Amsterdam (NL)
- Corresponding author
- Shah, Raj C
- Venue
- Alzheimer's Research & Therapy
- Published
- 2013-11-26
- Volume
- 5
- Issue
- 6
- Pages
- 59-59
- ISSN
- 1758-9193 (ISSN-L)
- PMC
- PMC3978853
- OpenAlex
- W1968911552
- Cited by
- 112
- References
- 31
- Citations by year
- 2026: 5 · 2025: 9 · 2024: 7 · 2023: 6 · 2022: 7 · 2021: 7 · 2020: 9 · 2019: 10 · 2018: 4 · 2017: 16 · 2016: 9 · 2015: 14 · 2014: 8 · 2013: 1
- FWCI
- 7.56
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Alzheimer s Research & Therapy (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
- Pure Amsterdam UMC (submittedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Funders
- University of Pennsylvania
- Wake Forest University
- Drexel University
- Rush University
- University of South Carolina
- Saint Louis University
- USF Health Byrd Alzheimer's Institute
- College of Medicine, Drexel University
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Life Sciences › Neuroscience › Neurology › Neurological Disorders and Treatments
- Keywords
- Alzheimer's disease, Souvenaid, medical foods, cognitive decline, uridine monophosphate, choline, phospholipids, omega-3 fatty acids, vitamin supplementation, dietary biomarkers, medication adherence, mild to moderate Alzheimer's disease
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