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 journalArticlepeer-review

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 Alzheimer's 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

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Geriatrics and Gerontology
  • Clinical Psychology
  • Medicine(all)

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