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Efficacy of Souvenaid in Mild Alzheimer's Disease: Results from a Randomized, Controlled Trial

Article type: Research Article

Authors: Scheltens, Philipa; * | Twisk, Jos W.R.b | Blesa, Rafaelc | Scarpini, Eliod | von Arnim, Christine A.F.e | Bongers, Ankef | Harrison, Johng; h | Swinkels, Sophie H.N.f | Stam, Cornelis J.i | de Waal, Hannekea | Wurtman, Richard J.j | Wieggers, Rico L.f | Vellas, Brunok | Kamphuis, Patrick J.G.H.f

Affiliations: [a] Alzheimer Center, VU University Medical Center, Amsterdam, The Netherlands | [b] Department of Clinical Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands | [c] Hospital de la Sta Creu i St. Pau, Barcelona, Spain | [d] Ospedale Maggiore Policlinico IRCCS, University of Milan, Milan, Italy | [e] Department of Neurology, Ulm University, Ulm, Germany | [f] Nutricia Advanced Medical Nutrition, Danone Research, Centre for Specialised Nutrition, Wageningen, The Netherlands | [g] Metis Cognition Ltd, Kilmington, UK | [h] Imperial College, London, UK | [i] Department of Clinical Neurophysiology, VU University Medical Center, Amsterdam, The Netherlands | [j] Department of Brain and Cognitive Sciences, Massachusetts Institute of Technology, Cambridge, MA, USA | [k] Gerontopole, INSERM U 1027, Toulouse, France

Correspondence: [*] Correspondence to: Prof. Philip Scheltens, Department of Neurology and Alzheimer Center, VU University Medical Center, De Boelelaan 1117, Amsterdam 1081 HV, The Netherlands. Tel.: +31 20 444 0816; Fax: +31 20 4440715; E-mail: [email protected].

Keywords: Alzheimer's disease, dietary management, medical food, membrane phosphatide synthesis, nutritional intervention, randomized clinical trial, synapse formation, synaptic activity

DOI: 10.3233/JAD-2012-121189

Journal: Journal of Alzheimer's Disease, vol. 31, no. 1, pp. 225-236, 2012

Accepted 1 June 2012
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Published: 5 July 2012
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Supplementary Materials:

Supplementary Materials.

Abstract

Souvenaid aims to improve synapse formation and function. An earlier study in patients with Alzheimer's disease (AD) showed that Souvenaid increased memory performance after 12 weeks in drug-naïve patients with mild AD. The Souvenir II study was a 24-week, randomized, controlled, double-blind, parallel-group, multi-country trial to confirm and extend previous findings in drug-naïve patients with mild AD. Patients were randomized 1 : 1 to receive Souvenaid or an iso-caloric control product once daily for 24 weeks. The primary outcome was the memory function domain Z-score of the Neuropsychological Test Battery (NTB) over 24 weeks. Electroencephalography (EEG) measures served as secondary outcomes as marker for synaptic connectivity. Assessments were done at baseline, 12, and 24 weeks. The NTB memory domain Z-score was significantly increased in the active versus the control group over the 24-week intervention period (p = 0.023; Cohen's d = 0.21; 95% confidence interval [−0.06]–[0.49]). A trend for an effect was observed on the NTB total composite z-score (p = 0.053). EEG measures of functional connectivity in the delta band were significantly different between study groups during 24 weeks in favor of the active group. Compliance was very high (96.6% [control] and 97.1% [active]). No difference between study groups in the occurrence of (serious) adverse events. This study demonstrates that Souvenaid is well tolerated and improves memory performance in drug-naïve patients with mild AD. EEG outcomes suggest that Souvenaid has an effect on brain functional connectivity, supporting the underlying hypothesis of changed synaptic activity.

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