Food and Behaviour Research

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

Scheltens P, Kamphuis PJ, Verhey FR, Olde Rikkert MG, Wurtman RJ, Wilkinson D, Twisk JW, Kurz A. (2010) Alzheimers Dement. 6(1) 1-10.e1. 

Web URL: View this and related abstracts via PubMed here

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.

2010 The Alzheimer's Association. All rights reserved.

FAB RESEARCH COMMENT:

Dietary supplementation with a combination of vitamins, minerals and omega-3 fatty acids led to significant benefits over placebo treatment in patients with early-stage Alzheimer's disease in this pilot human clinical trial.

The formulation being tested was specifically designed to include the wide range of nutrients needed for membrane synthesis and repair (via the so-called 'Kennedy pathway'). 

These initial findings are consistent with those already obtained from pre-clinical studies, but larger trials are now needed to see if these benefits can be confirmed.

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