|Main Findings of the Souvenaid Clinical Trial Program in Alzheimer's Disease|| |
|Department of Neurology and Alzheimer Center, VU University Medical Center, Amsterdam, The Netherlands|
|Objectives: Synaptic dysfunction is an important characteristic in early Alzheimer's disease (AD), when memory impairment is a key symptom. Souvenaid®1 is a medical food containing the nutrient combination Fortasyn®Connect1, designed to improve synapse formation and function in AD. Fortasyn Connect contains precursors and cofactors for the formation of neuronal membranes, needed for synapse synthesis. |
Methods: The efficacy of Souvenaid is evaluated in the clinical trial program.
Results: Two RCTs of 12- and 24-week duration demonstrated that Souvenaid improved memory performance in drug-naïve mild AD patients ('Souvenir I' and 'Souvenir II'). The 24-week open-label extension following Souvenir II showed a continued improvement of the exploratory memory outcome and that Souvenaid was well-tolerated (compliance ≥95%) throughout 48 weeks. The S-Connect RCT did not show an effect on cognition in mild to moderate AD patients using AD medication. Electroencephalograpy (EEG) measures were included in Souvenir II2 to study neuronal activity. Significant EEG effects suggest that Souvenaid preserves functional connectivity and brain network organisation in mild AD, supporting the hypothesis of changed synaptic activity.
Conclusions: These results suggest that Souvenaid is efficacious in early AD and warrant long-term trials in very early AD phases, like the ongoing 24-month LipiDiDiet study3 in prodromal AD. In other studies, Souvenaid's working mechanism is further studied using magnetoencephalography2 and magnetic resonance spectroscopy. Main and recent findings will be presented.
Annotations: 1Souvenaid and Fortasyn are registered trademarks of N.V. Nutricia. 2Partly funded by NL Food & Nutrition Delta project, FND N°10003.3Funded by the EU FP7 project LipiDiDiet, Grant Agreement N°211696.
Prof. Philip Scheltens, VU University Medical Center , Amsterdam , The Netherlands
Assigned in sessions:
06.03.2013, 11:00-13:00, Clinical, SYM05, SYMPOSIUM 05
NUTRITION BASED TREATMENTS
SUPPORTED BY AN UNRESTRICTED EDUCATIONAL GRANT BY NUTRICIA, Hall B