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CAMBRIDGE, Mass. —Researchers at the Massachusetts Institute of Technology (MIT) have released results of a recent clinical trial of a treatment for Alzheimer's disease. The treatment in question is a nutrient mixture that has been shown to improve memory in patients with early Alzheimer's by promoting new connections between neurons. The results of the trial appeared in the July 10 online edition of the Journal of Alzheimer's Disease.
Alzheimer's causes the loss of synapses, the connections between neurons. However, the new supplement mixture, Souvenaid, serves to stimulate new synapse growth, according to Dr. Richard Wurtman, a professor emeritus of brain and cognitive sciences at MIT and the inventor of Souvenaid.
The mixture consists of three naturally occurring dietary compounds: choline, uridine and DHA, an omega-3 fatty acid. Choline is present in meat, eggs and nuts, and omega-3 fatty acids can be found in foods such as fish, eggs, flaxseed and meat from grass-fed animals. As for uridine, the compound is naturally produced by the liver and kidney and is also found in some foods as an element of RNA. The nutrients are the forerunners to the lipid molecules that, in combination with certain proteins, comprise brain-cell membranes, which form synapses.
Wurtman notes that synapses usually have a lifespan of roughly six to 12 months, and the brain is constantly replacing them at essentially the same rate as they are lost. He likens the issue of synapse loss to that of a half-full bathtub, in which the drain is open and the faucet is on. Provided the output and input match, as with the loss and production of synapses in a healthy brain, the 'water' level remains the same. In seeking to raise the level, Wurtman notes that the options consist of plugging the drain—stopping the loss of synapses—or turning the water on higher.
The former, he notes, is the avenue most Alzheimer's disease researchers have pursued in the past, seeking to target amyloid a beta, which is known to be associated with the disease. It could still hold promise, "but it's been kind of disappointing in the last few years because now there are at least four different drugs that do lower amyloid, and they don't seem to help patients," says Wurtman, which is why his research has run towards trying to increase synapse formation in lieu of slowing synapse loss.
As for whether the use of Souvenaid can match or outpace that rate of degradation, Wurtman notes that it such a thing cannot be precisely measured, but it is possible to look at markers for numbers of synapses and see that after one week, two weeks or a month, the levels have increased.
He originally came up with the idea for targeting synapse loss roughly 10 years ago, and found that in animal studies, the cocktail served to increase the number of dendritic spines, small outcroppings of neural membranes in brain cells which are necessary for forming synapses between neurons. After the animal studies, Philip Scheltens, director of the Alzheimer Center at VU University Medical Center in Amsterdam, led a clinical trial in Europe in which Souvenaid was tested in 225 patients with mild Alzheimer's. The participants drank either Souvenaid or a control beverage every day for three months, and the first study, covered in 2008, resulted in 40 percent of patients taking Souvenaid seeing improvement in a test of verbal memory, while only 24 percent of patients receiving the control beverage improved.
Scheltens also oversaw the new study, in which 259 patients were followed for six months, as principal investigator. Patients in both the Souvenaid and placebo groups improved their verbal-memory performance for the first three months of the study, but while the placebo patients deteriorated in the second three months, the Souvenaid patients saw continued improvement. No serious side effects were seen. The use of EEG on patients showed that the brains of patients receiving the supplements began shifting from dementia patterns to those of more normal brain function, and since EEG patterns reflect synapse activity, the researchers noted that the results suggest an increase in synaptic function after treatment.
The mixture is not effective in those with severe dementia, Wurtman notes, which was confirmed in a previous study at Rush Medical School in Chicago. By the time dementia is particularly advanced, the brain is small and patients have lost many neurons, and as such cannot create new synapses. Those taking part in the study had very early onset Alzheimer's, averaging about 25 on a dementia scale from 1 to 30, with 30 being normal.
An additional study in prodromal patients—those who do not have Alzheimer's but are starting to exhibit memory loss—is currently in progress. Wurtman notes that there is a great deal of interest in looking at the applications of Souvenaid in other conditions as well, such as Parkinson's disease and stroke.
Nutricia, the specialized healthcare division of Danone (Dannon in the United States), sponsored both trials. While MIT has patented the nutrient mixture used in the study, Nutricia holds the exclusive license for the patent. Nutricia is currently testing and marketing Souvenaid, noted that plans for commercial release of the mixture are not finalized, but it is expected to be available in Europe first.