A New Option for Alzheimer’s Patients

Multi-nutrient drink from Nutricia/Danone shows promise amid ongoing research.

By
Joanna Cosgrove
Online Editor

According to the Alzheimer’s Association, as many as 5.2 million people in the U.S. are currently living with Alzheimer’s, and an estimated 10 million Baby Boomers will develop Alzheimer’s in their lifetime. The disease is the sixth-leading cause of death and the direct and indirect costs of Alzheimer’s and other dementias to Medicare, Medicaid and businesses amount to more than $148 billion each year (2008 Alzheimer’s Disease Facts and Figures).

Armed with such sobering statistics, researchers have been hard at work in search of new treatments to slow the progression of the disease and, if possible, a cure. Although science hasn’t revealed a therapy to eradicate Alzheimer’s, a promising new beverage is currently under development by Nutricia Advanced Medical Nutrition and being researched by Danone Research, part of Groupe Danone, at the company’s Centre for Specialised Nutrition, based in Wageningen, The Netherlands.

The product is called Souvenaid and is defined by the company as “a once-a-day multi-nutrient drink including Fortasyn Connect, a synergistic combination of active nutrients, for patients with Alzheimer’s disease.” Steve Graves, marketing director for Souvenaid, says the name was selected to give a sense and reminder of the core benefit that Souvenaid brings to someone living with Alzheimer’s, namely that of improved memory.

“Much of the conceptual work and early pre-clinical work was done at the Massachusetts Institute of Technology (MIT) under Professor Richard Wurtman, and supported principally by the National Institutes of Health (NIH),” explained professor Philip Scheltens, MD, PhD, of the Alzheimer Center of the VU University Medical Centre in Amsterdam.

“Souvenaid is designed to work on multiple pathways within the brain and to support the formation of synapses,” added Mr. Graves. “Souvenaid is the outcome of 10 years of research and pre-clinical development into the potential effects of nutrients on neurological disease.”

Signs of Promise

This past July, the results of a first stage clinical trial of Souvenaid were presented to the International Congress on Alzheimer’s disease (ICAD) in Chicago. The results indicated that Souvenaid may offer a new option in the management of people with mild Alzheimer’s disease.

People with Alzheimer’s disease exhibit a significant loss of brain synapses, resulting in the loss of cognitive function.Pre-clinical research conducted at MIT has shown specific combinations of certain nutrients interact to enhance brain cell outgrowth, synapse formation and neurotransmitter release; they’ve also been shown to improve cognitive function in several experimental models. Souvenaid was designed to improve synapse formation and synaptic transmission via “the synergistic action of a combination of nutrients” (Fortasyn Connect). This specific combination of nutrients has also been shown to reduce amyloid production as well as toxicity.

The randomized, double-blind, controlled trial led by professor Scheltens and sponsored by Danone Research, assessed the efficacy and safety of Souvenaid over 12 weeks. The results demonstrated that Souvenaid improves memory in patients with mild Alzheimer’s, has a good safety profile and is well tolerated.

A total of 212 people with mild Alzheimer’s disease who had not previously received Alzheimer’s disease medication participated in the Souvenaid study. The primary outcome measures were a delayed verbal memory task (derived from Wechsler Memory Scale-revised) and the 13-item Modified ADAS-cog. The researchers found a statistically significant benefit in mild and very mild Alzheimer’s patients on the delayed verbal memory task in the Souvenaid group. The unadjusted analyses showed no significant effect on the modified ADAS-cog. However, the baseline modified ADAS-cog score was a predictor for the intervention effect. Thus, patients with a higher baseline score showed a greater effect of Souvenaid on cognition. The researchers noted that there was no decline in modified ADAS-cog and verbal memory in the control group during the 12 weeks of the study.

“We’re very excited by these results and we look forward to further research on this product,” professor Scheltens said. “This is an innovative, completely different approach and we believe that medical nutrition products such as Souvenaid can be a valuable part of Alzheimer’s disease management. We’re committed to a high level of scientific rigor in the next trial to further test Souvenaid.”

Souvenaid is not yet on the market, but Mr. Graves explained that he and his colleagues “are encouraged by the results of the first clinical trial and will continue to invest to build the pyramid of evidence.” He added that a second clinical trial designed to confirm initial findings is expected to start shortly.