ArticleAlzheimer's research & therapy2013
The S-Connect study: results from a randomized, controlled trial of Souvenaid in mild-to-moderate Alzheimer's disease.
Article in Alzheimer's research & therapy, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 8 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
45 citing papers in PubMed, 8 syntheses or guidelines pooled it.
- Efficacy of antioxidants as a therapy for Alzheimer's disease: a meta-analysis.Frontiers in nutrition · 2026Pooled it
- The effects of omega-3, DHA, EPA, Souvenaid® in Alzheimer's disease: A systematic review and meta-analysis.Neuropsychopharmacology reports · 2024Pooled it
- Pooled it
- The effects of multi-nutrient formulas containing a combination ofThe British journal of nutrition · 2023Pooled it
- Effects of Selenium Supplementation in Patients with Mild Cognitive Impairment or Alzheimer's Disease: A Systematic Review and Meta-Analysis.Nutrients · 2022Pooled it
- Souvenaid for Alzheimer's disease.The Cochrane database of systematic reviews · 2020Pooled it
- The potential role of nutritional components in improving brain function among patients with Alzheimers disease: a meta-analysis of RCT studies.Neurosciences (Riyadh, Saudi Arabia) · 2020Pooled it
- Omega-3 Fatty Acids and Neurodegenerative Diseases: New Evidence in Clinical Trials.International journal of molecular sciences · 2019Pooled it
- Trial
- 36-month LipiDiDiet multinutrient clinical trial in prodromal Alzheimer's disease.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2021Trial
- The LipiDiDiet trial: what does it add to the current evidence for Fortasyn Connect in early Alzheimer's disease?Clinical interventions in aging · 2019Trial
- 24-month intervention with a specific multinutrient in people with prodromal Alzheimer's disease (LipiDiDiet): a randomised, double-blind, controlled trial.The Lancet. Neurology · 2017Trial
- Effect Size Analyses of Souvenaid in Patients with Alzheimer's Disease.Journal of Alzheimer's disease : JAD · 2017Trial
- Effects of Souvenaid on plasma micronutrient levels and fatty acid profiles in mild and mild-to-moderate Alzheimer's disease.Alzheimer's research & therapy · 2015Trial
- Dietary Patterns, Micronutrient Adequacy, and Metabolic Vulnerability in Alzheimer's Disease: A Critical Narrative Review.Nutrients · 2026Review
- Dietary Nucleotides as Potential Modulators of Inflammatory and Metabolic Pathways with Implications for Insulin Resistance.International journal of molecular sciences · 2026Review
- Effects of oral nutritional supplements plus mature silkworm pill on cognitive function in Korean adults with mild cognitive impairment: a 12-week randomized blinded clinical trial.Frontiers in nutrition · 2025Article
- Unveiling the Therapeutic Potential of Folate-Dependent One-Carbon Metabolism in Cancer and Neurodegeneration.International journal of molecular sciences · 2024Review
- An analysis of omega-3 clinical trials and a call for personalized supplementation for dementia prevention.Expert review of neurotherapeutics · 2024Review
- FORTCARE-MCI study protocol: evaluation of Fortasyn Connect in the management of mild cognitive impairment in primary care.Frontiers in neurology · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionSouvenaid® 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.
methodsIn 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.
resultsCognitive 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.
conclusionsAdd-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 registrationDUTCH TRIAL REGISTER NUMBER: NTR1683.
Identifiers
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.