Marcel G M Olde Rikkert1, Frans R Verhey2, Rafael Blesa3, Christine A F von Arnim4, Anke Bongers5, John Harrison6, John Sijben5, Elio Scarpini7, Maurits F J Vandewoude8, Bruno Vellas9, Renger Witkamp10, Patrick J G H Kamphuis5, Philip Scheltens11. 1. Radboud Alzheimer Centre, Department of Geriatric Medicine, Radboud University Hospital, Nijmegen, The Netherlands. 2. Alzheimer Centre Limburg, Maastricht University Medical Centre, Maastricht, The Netherlands. 3. Department of Neurology, Hospital de la Sta Creu i St. Pau, Barcelona, Spain. 4. Department of Neurology, Ulm University, Ulm, Germany. 5. Nutricia Advanced Medical Nutrition, Nutricia Research, Utrecht, The Netherlands. 6. Metis Cognition Ltd, Kilmington, UK & Imperial College, London, UK. 7. University of Milan, Fondazione Cà Granda, IRCCS Ospedale Policlinico, Milan, Italy. 8. University Department of Geriatrics, Antwerp Hospital Network (ZNA St Elisabeth), University of Antwerp, Belgium. 9. Gerontopole, INSERM U 1027, Toulouse, France. 10. Division of Human Nutrition, Wageningen University, Wageningen, The Netherlands. 11. Alzheimer Center, VU University Medical Center, Amsterdam, The Netherlands.
Abstract
BACKGROUND: The medical food Souvenaid, containing the specific nutrient combination Fortasyn Connect, is designed to improve synapse formation and function in patients with Alzheimer's disease (AD). Two double-blind randomized controlled trials (RCT) with Souvenaid of 12 and 24 week duration (Souvenir I and Souvenir II) showed that memory performance was improved in drug-naïve mild AD patients, whereas no effects on cognition were observed in a 24-week RCT (S-Connect) in mild to moderate AD patients using AD medication. Souvenaid was well-tolerated in all RCTs. OBJECTIVE: In this 24-week open-label extension (OLE) study to the 24-week Souvenir II RCT, long-term safety and intake adherence of the medical food Souvenaid was evaluated. METHODS:Patients with mild AD (n = 201) received Souvenaid once-daily during the OLE. Main outcome parameters were safety and product intake adherence. The memory domain z-score from a revised neuropsychological test battery was continued as exploratory parameter. RESULTS: Compared to the RCT, a similar (low) incidence and type of adverse events was observed, being mainly (68.3%) of mild intensity. Pooled data (RCT and OLE) showed that 48-week use of Souvenaid was well tolerated with high intake adherence (96.1%). Furthermore, a significant increase in the exploratory memory outcome was observed in both the active-active and control-active groups during Souvenaid intervention. CONCLUSION:Souvenaid use for up to 48-weeks was well tolerated with a favorable safety profile and high intake adherence. The findings in this OLE study warrant further investigation toward the long-term safety and efficacy of Souvenaid in a well-controlled, double-blind RCT.
RCT Entities:
BACKGROUND: The medical food Souvenaid, containing the specific nutrient combination Fortasyn Connect, is designed to improve synapse formation and function in patients with Alzheimer's disease (AD). Two double-blind randomized controlled trials (RCT) with Souvenaid of 12 and 24 week duration (Souvenir I and Souvenir II) showed that memory performance was improved in drug-naïve mild ADpatients, whereas no effects on cognition were observed in a 24-week RCT (S-Connect) in mild to moderate ADpatients using AD medication. Souvenaid was well-tolerated in all RCTs. OBJECTIVE: In this 24-week open-label extension (OLE) study to the 24-week Souvenir II RCT, long-term safety and intake adherence of the medical food Souvenaid was evaluated. METHODS:Patients with mild AD (n = 201) received Souvenaid once-daily during the OLE. Main outcome parameters were safety and product intake adherence. The memory domain z-score from a revised neuropsychological test battery was continued as exploratory parameter. RESULTS: Compared to the RCT, a similar (low) incidence and type of adverse events was observed, being mainly (68.3%) of mild intensity. Pooled data (RCT and OLE) showed that 48-week use of Souvenaid was well tolerated with high intake adherence (96.1%). Furthermore, a significant increase in the exploratory memory outcome was observed in both the active-active and control-active groups during Souvenaid intervention. CONCLUSION:Souvenaid use for up to 48-weeks was well tolerated with a favorable safety profile and high intake adherence. The findings in this OLE study warrant further investigation toward the long-term safety and efficacy of Souvenaid in a well-controlled, double-blind RCT.
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