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Tolerability and Safety of Souvenaid in Patients with Mild Alzheimer's Disease: Results of Multi-Center, 24-Week, Open-Label Extension Study

Article type: Research Article

Authors: Olde Rikkert, Marcel G.M.a; * | Verhey, Frans R.b | Blesa, Rafaelc | von Arnim, Christine A.F.d | Bongers, Ankee | Harrison, Johnf | Sijben, Johne | Scarpini, Eliog | Vandewoude, Maurits F.J.h | Vellas, Brunoi | Witkamp, Rengerj | Kamphuis, Patrick J.G.H.e | Scheltens, Philipk

Affiliations: [a] Radboud Alzheimer Centre, Department of Geriatric Medicine, Radboud University Hospital, Nijmegen, The Netherlands | [b] Alzheimer Centre Limburg, Maastricht University Medical Centre, Maastricht, The Netherlands | [c] Department of Neurology, Hospital de la Sta Creu i St. Pau, Barcelona, Spain | [d] Department of Neurology, Ulm University, Ulm, Germany | [e] Nutricia Advanced Medical Nutrition, Nutricia Research, Utrecht, The Netherlands | [f] Metis Cognition Ltd, Kilmington, UK & Imperial College, London, UK | [g] University of Milan, Fondazione Cà Granda, IRCCS Ospedale Policlinico, Milan, Italy | [h] University Department of Geriatrics, Antwerp Hospital Network (ZNA St Elisabeth), University of Antwerp, Belgium | [i] Gerontopole, INSERM U 1027, Toulouse, France | [j] Division of Human Nutrition, Wageningen University, Wageningen, The Netherlands | [k] Alzheimer Center, VU University Medical Center, Amsterdam, The Netherlands

Correspondence: [*] Correspondence to: Marcel Olde Rikkert, MD, PhD, Radboud Alzheimer Center, Department of Geriatric Medicine, Radboud University Hospital, P.O. Box 9101, 6500 HB Nijmegen, The Netherlands. Tel.: +31 24 361 67 72; Fax: +31 24 361 74 08; E-mail: [email protected].

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

DOI: 10.3233/JAD-141305

Journal: Journal of Alzheimer's Disease, vol. 44, no. 2, pp. 471-480, 2015

Accepted 2 September 2014
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Published: 22 January 2015
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Supplementary Materials:

Supplementary Material.

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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