Efficacy of souvenaid in mild alzheimer's disease : Results from a randomized, controlled trial
Scheltens, Philip (Amsterdam University Medical Center (UMC))
Twisk, Jos W.R. (Amsterdam University Medical Center (UMC))
Blesa, Rafael (Institut d'Investigació Biomèdica Sant Pau)
Scarpini, Elio (University of Milan)
Von Arnim, Christine A.F. (Ulm University (Alemanya))
Bongers, Anke (Centre for Specialised Nutrition (Països Baixos))
Harrison, John (Imperial College London)
Swinkels, Sophie H.N. (Centre for Specialised Nutrition (Països Baixos))
Stam, Cornelis J. (Amsterdam University Medical Center (UMC))
De Waal, Hanneke (Amsterdam University Medical Center (UMC))
Wurtman, Richard J. (Massachusetts Institute of Technology)
Wieggers, Rico L. (Centre for Specialised Nutrition (Països Baixos))
Vellas, Bruno (Gerontopole (Toulouse, França))
Kamphuis, Patrick J.G.H. (Centre for Specialised Nutrition (Països Baixos))
Universitat Autònoma de Barcelona

Data:	2012
Resum:	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. © 2012 - IOS Press and the authors. All rights reserved.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Alzheimer's disease ; Dietary management ; Medical food ; Membrane phosphatide synthesis ; Nutritional intervention ; Randomized clinical trial ; Synapse formation ; Synaptic activity
Publicat a:	Journal of Alzheimer's disease, Vol. 31 Núm. 1 (2012) , p. 225-236, ISSN 1875-8908

DOI: 10.3233/JAD-2012-121189
PMID: 22766770

12 p, 556.5 KB

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