|Title||Tolerability and safety of souvenaid in patients with mild Alzheimer's disease : Results of multi-center, 24-week, open-label extension study|
|Author(s)||Olde Rikkert, Marcel G.M.; Verhey, Frans R.; Blesa, Rafael; Arnim, Christine A.F. Von; Bongers, Anke; Harrison, John; Sijben, John; Scarpini, Elio; Vandewoude, Maurits F.J.; Vellas, Bruno; Witkamp, Renger; Kamphuis, Patrick J.G.H.; Scheltens, Philip|
|Source||Journal of Alzheimers Disease 44 (2015)2. - ISSN 1387-2877 - p. 471 - 480.|
Chair Nutrition and Pharmacology (HNE)
|Publication type||Refereed Article in a scientific journal|
|Keyword(s)||Alzheimer's disease - clinical trial - dietary management - intervention studies - long-term - medical nutrition therapy - memory - patient adherence - safety|
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.