He originally came up with the idea for targeting synapseloss roughly 10 years ago, and found that in animal studies, the cocktailserved to increase the number of dendritic spines, small outcroppings of neuralmembranes in brain cells which are necessary for forming synapses betweenneurons. After the animal studies, Philip Scheltens, director of the AlzheimerCenter at
VU University Medical Center in Amsterdam, led a clinical trial inEurope in which Souvenaid was tested in 225 patients with mild Alzheimer's. Theparticipants drank either Souvenaid or a control beverage every day for threemonths, and the first study, covered in 2008, resulted in 40 percent ofpatients taking Souvenaid seeing improvement in a test of verbal memory, whileonly 24 percent of patients receiving the control beverage improved.
Scheltens also oversaw the new study, in which 259 patientswere followed for six months, as principal investigator. Patients in both theSouvenaid and placebo groups improved their verbal-memory performance for thefirst three months of the study, but while the placebo patients deteriorated inthe second three months, the Souvenaid patients saw continued improvement. Noserious side effects were seen. The use of EEG on patients showed that thebrains of patients receiving the supplements began shifting from dementiapatterns to those of more normal brain function, and since EEG patterns reflectsynapse activity, the researchers noted that the results suggest an increase insynaptic 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 Schoolin Chicago. By the time dementia is particularly advanced, the brain is smalland patients have lost many neurons, and as such cannot create new synapses. Thosetaking part in the study had very early onset Alzheimer's, averaging about 25on a dementia scale from 1 to 30, with 30 being normal.
An additional study in prodromal patients—those who do nothave Alzheimer's but are starting to exhibit memory loss—is currently inprogress. Wurtman notes that there is a great deal of interest in looking atthe applications of Souvenaid in other conditions as well, such as Parkinson'sdisease and stroke.
Nutricia, the specialized healthcare division of
Danone(Dannon in the United States), sponsored both trials. While MIT has patentedthe nutrient mixture used in the study, Nutricia holds the exclusive licensefor the patent. Nutricia is currently testing and marketing Souvenaid, notedthat plans for commercial release of the mixture are not finalized, but it isexpected to be available in Europe first.