Staff Publications

Staff Publications

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    'Staff publications' is the digital repository of Wageningen University & Research

    'Staff publications' contains references to publications authored by Wageningen University staff from 1976 onward.

    Publications authored by the staff of the Research Institutes are available from 1995 onwards.

    Full text documents are added when available. The database is updated daily and currently holds about 240,000 items, of which 72,000 in open access.

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Record number 498368
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.
DOI http://dx.doi.org/10.3233/JAD-141305
Department(s) Chair Nutrition and Pharmacology (HNE)
VLAG
Publication type Refereed Article in a scientific journal
Publication year 2015
Keyword(s) Alzheimer's disease - clinical trial - dietary management - intervention studies - long-term - medical nutrition therapy - memory - patient adherence - safety
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.

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