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| |  Medical Food Product Gets Mixed Results in Alzheimer's Trial: Presented at ICAD By Ed Susman VIENNA, Austria -- July 16, 2009 -- An experimental medical food (Souvenaid) showed mixed results in a randomised, controlled, double-blind clinical trial among patients with Alzheimer's disease, researchers stated here at the Alzheimer's Association 2009 International Conference on Alzheimer's Disease (ICAD). The researchers reported statistically significant improvements in a memory test, but failed to differentiate from control patients in cognitive member tests. "[Medical food] improves memory in patients with mild Alzheimer's disease," said Philip Scheltens, MD, VU University Medical Center, Amsterdam, the Netherlands, in a poster presentation on July 15. "[The medical food] also has a good safety and tolerability profile." He noted that overall, 97% of patients stayed on the medical food, while 95% of the control patients remained in the 12-week duration study, and 94% of the medical food patients and 93% of the control population stayed on for an addition 12-week extension. In the study, Dr. Scheltens and colleagues enrolled 212 patients diagnosed with early or very early-stage Alzheimer's disease at 28 sites in the Netherlands, Belgium, Germany and the United States. They were testing the food product known as Fortasyn Connect, a drink formulated to contain ingredients in 6 functional categories: uridine-5'-monophosphate; omega-3 fatty acids; choline; phospholipids; B vitamins, and antioxidants. In the Alzheimer's Disease Assessment Scale-cognition (ADAS-cog) subscale, Dr. Scheltens said there was no significant difference between the groups. Overall, in the Wechsler Memory Scale-Revised test, the researchers observed statistically significant improvements (P = .021), with about 40% of the patients improving compared with 25% of the control patients. In just the very mild cases, the improvement was more profound, with about 49% of the patients on the experimental medical food demonstrating improvement compared with about 25% of the control patients. The patients in the study were about evenly divided between men and women, and the subjects were about 74 years of age. Of the 212 patients in the study, 106 were assigned to each of the 2 arms of the trial. The baseline ADAS-cog scores were about 24 for each group; the Wechsler scores were 1.0 for the medical food group of patients and 2.0 for the control group. That difference was not significant (P = .299). Dr. Scheltens reported no differences in serious adverse side effect between the 2 groups; there were no clinically relevant differences in blood safety parameters; and the number of dropouts was similar in each group. Funding for this study was provided by Danone. [Presentation title: The Efficacy of a Medical Food (Souvenaid) in Alzheimer's Disease: Results First Trial and Design of Future Trials. P4-349]
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