By Emma Hitt, PhD
SINGAPORE -- March 27, 2009 -- Use of an investigational multinutrient medical food containing omega-3 fatty acids and antioxidants appears to increase memory compared with an isocaloric control drink after 12 weeks of once-daily consumption in patients with mild Alzheimer's disease, according to research presented here at the 24th Conference of Alzheimer's Disease International (ADI).
Patrick JGH Kamphuis, MD, Danone Research Centre for Specialized Nutrition, Wageningen, the Netherlands, presented the findings here on March 27 at an oral session.
"The medical food contains uridine-5'-monophosphate, omega-3 fatty acids, choline/phospholipids, B vitamins, and antioxidants, and has been designed to improve the formation of synapses," Dr. Kamphuis noted during his talk.
"Several preclinical studies have demonstrated that specific combinations of these agents may stimulate synapse formation," he added.
Dr. Kamphuis and colleagues at University Medical Centre in Amsterdam and Massachusetts Institute of Technology, Cambridge, Massachusetts, conducted a randomised, double-blind, multicentre trial with 212 patients at 28 sites.
Patients were randomised to receive the medical food at a dose of 125 mL once daily or an isocaloric control drink once daily, both for 12 weeks with an additional optional follow-up period of 12 weeks.
A total of 160 patients completed the entire 24 weeks. Patients had a "probable" Alzheimer's diagnosis with a Mini-Mental State Exam (MMSE) score of 20 to 26 and had not received previous treatment for Alzheimer's disease.
Patients were assessed at 12 weeks for delayed verbal memory using the Wechsler Memory Scale-Revised and with the 13-item Alzheimer's Disease Assessment Scale-cognitive subscale (ADA-cog-13).
There were no differences in rates of serious adverse events or dropout rates due to adverse events between the 2 groups.
Overall compliance was 95% for the medical food group and 93% for the control group over the 24-week period.
The medical food was also found to increase docosahexaenoic acid levels (P < .001) and to reduce homocysteine plasma levels (P < .001) compared with control.
In addition, a significant change from baseline at 12 weeks was seen in patients with mild Alzheimer's disease (P = .026) and in patients with very mild Alzheimer's disease (P = .011), as measured by changes in the delayed verbal memory score.
However, there was no difference in the ADA-cog-13 scores between the groups.
According to Dr. Kamphuis, "The medical food had a good safety profile and was well tolerated."
"A second randomised, clinical trial is underway," he said.
Funding for this study was provided by Danone.
[Presentation title: The Efficacy of a Medical Food (Souvenaid(R)) in Alzheimer's Disease: Results First Randomized Controlled Trial and Design Future Trials. Abstract LIS-PS02]
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