A new study touting the benefits of a nutrient cocktail in preventing Alzheimer's disease is drawing fire from experts who say the results are being misrepresented.
The drink, known as Souvenaid, was developed by the French company Danone, known as Dannon in the U.S., and was based on research done at the Massachusetts Institute of Technology. It is not currently on the market.
To conduct the study, researchers in the Netherlands gave Souvenaid, which includes B vitamins, phospholipids and antioxidants, to 225 patients with Alzheimer's disease. After 12 weeks, the cocktail appeared to show a slight benefit to patients who had taken it versus those in a placebo group.
The researchers said that the "proof-of-concept study justifies further clinical trials." Indeed, several such studies are currently under way.
However, numbers in the study indicated a reasonably high probability that some of the results could be due to chance, and some of the drink's apparent benefits seemed to disappear quickly, critics say.
"I see little evidence to support the use of this beverage to improve memory in [Alzheimer's disease patients]," said Dr. Paul Aisen, a noted Alzheimer's disease expert and professor at the University of California, San Diego. "It was a small study of treatment-naïve [Alzheimer's] patients lasting only 12 weeks." By 24 weeks, the memory differences seen after 12 weeks had disappeared.
The study was published in the most recent issue of the journal Alzheimer's & Dementia.
Experts also pointed out that some of the memory tests failed to show any improvement in people using the cocktail.
"This is a study which I would look at as negative," said Dr. Constantine Lyketsos, director of the Neuropsychiatry Service at Johns Hopkins Medical Institution. "The major outcome measures showed no effect at any time point."
Dr. Richard Besser, senior medical editor for ABC News, noted some troubling aspects of the study that related to its potential marketing, including conflicts of interest by the authors.
"They hold the patent on the nutritional cocktail and some serve on the advisory board for Dannon. The study was funded by Dannon," he said.
Other experts, too, were critical of the study.
"While everyone would clearly like to have some safe and easy to take method to stave off Alzheimer's disease, there are several features of this study that should raise concerns," said Dr. Clifford Saper, chairman of the Department of Neurology at Beth Israel Deaconess Medical Center in Boston. "They would include the involvement of the commercial sponsors at every level of this study, including writing the first draft of the paper; and the relatively low level of improvement on a single test out of a large battery of examinations."
Study co-author Dr. Richard Wurtman of MIT in Boston said he didn't think the sponsor was overly involved, but added he -- as a basic scientist -- was himself not deeply involved in the clinical aspect of the trial.
And in an e-mail, study author Dr. Philip Scheltens of VU University Medical Center in Amsterdam, the Netherlands, said the trial is "a proof of concept that urges further study, which we are doing."
He added that the study was indeed analyzed by the sponsor, but also by an external statistician, who is also a co-author of the paper.
Meeting a Need
There has been a strong desire for an effective Alzheimer's drug, given the number of people who suffer from the ailment -- a number that will grow if demographic trends continue.
"There is a tremendous unmet need since existing drugs offer only symptomatic benefits," said Dr. Murali Doraiswamy, chief of the division of biological psychiatry at Duke Medical Center.
However, he cautioned, "At this point I would not recommend that anyone get excited by this or start medicating themselves with these ingredients till we have results from more definitive studies. At best, this study offers some grounds for further testing."
He noted that while the ingredients had been suspected of having brain benefits in the past, "none of the ingredients have been shown to work in prior large scale trials of people with Alzheimer's."
Also, Doraiswamy said, a trial would need to be significantly longer for a product to be seriously considered.
"The typical standard for a definitive FDA trial is six-month duration," Doraiswamy said.
MedPage Today's Michael Smith contributed to this report.