Efficacy of a medical food in mild Alzheimer's disease: A randomized, controlled trial

Abstract

Objective

To investigate the effect of a medical food on cognitive function in people with mild Alzheimer's disease (AD).

Methods

A total of 225 drug-naïve AD patients participated in this randomized, double-blind controlled trial. Patients were randomized to active product, Souvenaid, or a control drink, taken once-daily for 12 weeks. Primary outcome measures were the delayed verbal recall task of the Wechsler Memory Scale–revised, and the 13-item modified Alzheimer's Disease Assessment Scale–cognitive subscale at week 12.

Results

At 12 weeks, significant improvement in the delayed verbal recall task was noted in the active group compared with control (P = .021). Modified Alzheimer's Disease Assessment Scale–cognitive subscale and other outcome scores (e.g., Clinician Interview Based Impression of Change plus Caregiver Input, 12-item Neuropsychiatric Inventory, Alzheimer's disease Co-operative Study–Activities of Daily Living, Quality of Life in Alzheimer's Disease) were unchanged. The control group neither deteriorated nor improved. Compliance was excellent (95%) and the product was well tolerated.

Conclusions

Supplementation with a medical food including phosphatide precursors and cofactors for 12 weeks improved memory (delayed verbal recall) in mild AD patients. This proof-of-concept study justifies further clinical trials.

Keywords: Alzheimer's disease, Nutritional intervention, Synapse formation, Membrane phosphatide synthesis, B vitamins, Omega-3 fatty acids, Nucleotides, Uridine, Phospholipids, Choline, Antioxidants, ADAS-cog, delayed verbal recall, Medical food, Dietary management, Randomized clinical trial, Dementia

a Alzheimer Center, VU University Medical Center, Amsterdam, The Netherlands

b Danone Research, Centre for Specialised Nutrition, Wageningen, The Netherlands

c Alzheimer Centre Limburg, Maastricht University Medical Centre, The Netherlands

d Alzheimer Centre Nijmegen, Radboud University Medical Centre Nijmegen, The Netherlands

e Department of Brain and Cognitive Sciences, Massachusetts Institute of Technology, Cambridge, MA, USA

f Memory Assessment and Research Centre, Moorgreen Hospital, Southampton, United Kingdom

g Department of Health Sciences, VU University Medical Center, Amsterdam, The Netherlands

h Department of Psychiatry, Klinikum Rechts der Isar, Technische Universität München, Germany

Corresponding author. Tel.: 31-20-444-0742; Fax: 31-20-444-0715.

Potential conflicts of interest: P. Scheltens is employed by VU University Medical Center, Amsterdam. The Alzheimer Center VU University Medical Center receives unrestricted funding from Danone Research. He is a member of the Nutricia Advisory Board; P.J.G.H. Kamphuis is an employee of Danone Research; F.R.J. Verhey is employed by the Department of Psychiatry and Neuropsychology of the Maastricht University Medical Centre. He is a member of the Nutricia Advisory Board; M.G.M. Olde Rikkert is employed by the Geriatric Department of the Radboud University Medical Centre Nijmegen. He is a member of the Nutricia Advisory Board; R.J. Wurtman is employed by The Massachusetts Institute of Technology, which owns patents on uridine, omega-3 fatty acids, and choline to treat brain diseases by enhancing synapses. He is consultant to the Danone Company and advises on research related to such uses; D. Wilkinson has no conflicts of interest to declare; J.W.R. Twisk has no conflicts of interest to declare; A. Kurz has no conflicts of interest to declare.

Contributors: Investigators: P. Scheltens, M.G.M. Olde Rikkert, F. Verhey, P. Dautzenberg, R.J. van Marum, L. Boelaarts, J.P.J. Slaets, D.C.M. Verheijen, S. Stevens, A. Weverling, E. Sanders, A. Kurz, H. Gertz, V. Holthoff, J. Schröder, H. Jahn, R. Horn, M. Ribbat, G. Reifschneider, K. Oehler, R. Schellenberg, K. Steinwachs, R. Vandenberghe, P.P. de Deyn, N. de Klippel, M. Petrovic, Ph. Bourgeois, Ph. PPMGA Tack, D. Wilkinson, T.K. Malstrom; Steering committee: M.J. van der Mooren (Chairman), P. Scheltens, P.J.G.H. Kamphuis; Independent data monitoring committee: I.G. McKeith, K. Rockwood, J.H. Koeman, J.W.R. Twisk.

PII: S1552-5260(09)02329-2

doi:10.1016/j.jalz.2009.10.003

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