Tolerability and safety of souvenaid in patients with mild Alzheimer's disease: results of multi-center, 24-week, open-label extension study
Articolo
Data di Pubblicazione:
2015
Citazione:
Tolerability and safety of souvenaid in patients with mild Alzheimer's disease: results of multi-center, 24-week, open-label extension study / M.G.M. Olde Rikkert, F.R. Verhey, R. Blesa, C.A.F. Von Arnim, A. Bongers, J. Harrison, J. Sijben, E. Scarpini, M.F.J. Vandewoude, B. Vellas, R. Witkamp, P.J.G.H. Kamphuis, P. Scheltens. - In: JOURNAL OF ALZHEIMER'S DISEASE. - ISSN 1387-2877. - 44:2(2015), pp. 471-480. [10.3233/JAD-141305]
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.
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
Alzheimer's disease; clinical trial; dietary management; intervention studies; long-term; medical nutrition therapy; memory; patient adherence; safety
Elenco autori:
M.G.M. Olde Rikkert, F.R. Verhey, R. Blesa, C.A.F. Von Arnim, A. Bongers, J. Harrison, J. Sijben, E. Scarpini, M.F.J. Vandewoude, B. Vellas, R. Witkamp, P.J.G.H. Kamphuis, P. Scheltens
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