To evaluate the efficacy and safety of Souvenaid on cognitive function in patients with mild-to-moderate Alzheimer’s disease taking AD medication, over a 24-week period.
The cognitive performance was assessed by the 11-item modified Alzheimer's Disease Assessment Scale-cognition (ADAS-cog).
The S-Connect study is a 24-week randomised, controlled, double-blind trial in 527 patients with mild-to-moderate Alzheimer’s disease: MMSE scores ranging from 14-24. All patients were stable on AChEI and/or NMDAr-antagonist for 4 months prior to baseline and were expected to continue use throughout the study period.
Souvenaid was well tolerated in combination with standard medication for Alzheimer’s disease. Patient compliance was >90% in both groups. No difference was observed between the Souvenaid and control group on the primary outcome measure.
Souvenaid intake over 24 weeks did not improve cognition in these patients who were in a more advanced stage of their disease than in previous trials (Souvenir I and Souvenir II). However, Souvenaid was well tolerated in combination with standard care Alzheimer's medication and overall compliance was very high. It is hypothesized that these patients were too far down the pathological cascade with neuronal damage and synaptic dysfunction that had accumulated to an irreversible degree. The production of synapses requires neurons: the benefit of synaptogenesis in the moderate population, therefore, may be limited due to the more advanced neurodegeneration.
S-Connect baseline characteristics
The baseline characteristics of the patients were comparable between groups .
S-Connect results (ADAS-Cog)
In this study, no significant difference was found between the active and control groups on the ADAS-Cog test. Both groups showed a moderate increase of ADAS-cog scores, suggesting cognitive deterioration in-line with expectations for this population.
S-Connect results (biochemical changes in DHA, EPA, homocysteine and Vitamin E)
A significant uptake of DHA and EPA into the erythrocyte membranes, increased plasma vitamin E levels and decreased homocysteine levels were observed for the active group compared to the control group over the 24 week intervention period (p < 0.001, Mann–Whitney U test).
527 patients with mild-to-moderate Alzheimer’s disease were randomised to the Souvenaid or control group.
The levels of compliance were very high in both groups .
Souvenaid tolerability profile: all reported adverse events (irrespective of relationship to study product)
There was no difference in the incidence of adverse events between groups.
Souvenaid was well tolerated in combination with standard medication for Alzheimer’s disease.
Shah R, Kamphuis P, Leurgans S, Swinkels S, Sadowsky C, Bongers A, et al (2013) The S-Connect study: : results from a randomized, controlled trial of Souvenaid. Alzheimer's Research & Therapy,5:59