Tolerability and safety of souvenaid in patients with mild Alzheimer's disease: Results of multi-center, 24-week, open-label extension study

Marcel G.M. Olde Rikkert, Frans R. Verhey, Rafael Blesa, Christine A.F. Von Arnim, Anke Bongers, John Harrison, John Sijben, Elio Scarpini, Maurits F.J. Vandewoude, Bruno Vellas, Renger Witkamp, Patrick J.G.H. Kamphuis, Philip Scheltens

Research output: Contribution to journalArticleAcademicpeer-review

35 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)471-480
Number of pages10
JournalJournal of Alzheimers Disease
Volume44
Issue number2
DOIs
Publication statusPublished - 2015

Keywords

  • Alzheimer's disease
  • clinical trial
  • dietary management
  • intervention studies
  • long-term
  • medical nutrition therapy
  • memory
  • patient adherence
  • safety

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