SouvenaidTM, a multi-nutrient drink, is designed to improve cognitive function, and is the result of ten years of research and development into the potential role of nutrients in neurological diseases.
Pre-clinical research using a technique invented by Massachusetts Institute of Technology (MIT) has shown that specific combinations of nutrients can increase synapse formation. Now a double-blind, controlled study with SouvenaidTM, including these nutrients, has shown it may help patients with mild Alzheimer’s Disease.
Proof of Concept Clinical Trial of SouvenaidTM: A Medical Nutrition Approach to Mild Alzheimer’s
People with Alzheimer’s exhibit a significant loss of brain synapses, and this loss correlates with the loss of cognitive function. Pre-clinical research using a technique invented by Massachusetts Institute of Technology (MIT) has shown that specific combinations of nutrients can increase synapse formation. Now a double-blind, controlled study with SouvenaidTM, including these nutrients, has shown it may help patients with mild Alzheimer’s Disease.
SouvenaidTM, developed by Danone Research – Centre for Specialised Nutrition, is designed to improve synapse formation and synaptic transmission via the synergistic action of a combination of nutrients (specifically, it contains uridine monophosphate, choline, the omega-3 fatty acids (EPA, DHA), phospholipids, B vitamins and antioxidants). Pre-clinical research has shown that specific combinations of certain nutrients interact to enhance brain cell outgrowth, synapse formation, and neurotransmitter release and also improved cognitive function in several pre-clinical models. This specific combination of nutrients showed also reduced amyloid production and toxicity in the pre-clinical models.
At ICAD 2008, Philip Scheltens, MD, PhD, of the Alzheimer Center of the VU University Medical Centre, Amsterdam, the Netherlands reported the results of a randomised, double-blind, controlled 12-week trial, sponsored by Danone Research, to assess the safety and effect of SouvenaidTM on memory and cognitive performance in people with mild Alzheimer’s (MMSE 20-26, mean=23.9) who had never taken any Alzheimer’s drugs.
Two hundred twelve (212) people with mild Alzheimer’s were recruited for the trial at 28 sites mainly in the Netherlands, Germany, and Belgium, with a single site in the U.S.; 106 were assigned to SouvenaidTM, a 125 ml (125 kcal) once-a-day drink, and 106 to control in the 12-week study. Primary outcome measures were a delayed verbal memory task derived from the Wechsler Memory Scale-revised and the 13-item modified ADAS-cog. Secondary outcomes included the MMSE, 23-item Alzheimer’s Disease Cooperative Study – Activities of Daily Living Inventory (ADCS-ADL), 12-item Neuropsychiatric Inventory (NPI), Clinician’s Interview Based Impression of Change plus Caregiver Input (CIBIC-plus) and Quality of Life in Alzheimer’s Disease (QOL-AD). A separate analysis was performed on a pre-specified subgroup of very mild Alzheimer’s (MMSE>23). In an optional, double-blind, 12-week extension phase, patients continued to receive the same study product (85 percent of the week 12 completers continued into the extension phase).
The investigators found a statistically significant benefit in mild Alzheimer’s patients on the delayed verbal memory task in the SouvenaidTM group, and also a significant effect in the subgroup of very mild patients. 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 SouvenaidTM on cognition. The investigators noted that there was no decline in modified ADAS-cog and verbal memory in the control group during the 12 weeks of the study.
According to the investigators, SouvenaidTM was well tolerated (compliance=94 percent) and showed a good safety profile. The drop-out rate in the study was low – 6.6 percent in first 12 weeks, 4.8 percent in the 12-week extension. They found no significant difference in adverse effects between the study groups throughout the study period.
“We’re very excited by these results and we look forward to further research on this product,” Scheltens said. “This is an innovative, completely different approach and we believe that medical foods such as SouvenaidTM 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 SouvenaidTM.”
“SouvenaidTM is a medical food product backed by 10 years of research. Much of the conceptual work and early pre-clinical work was done at MIT under Professor Richard Wurtman, and supported principally by the National Institutes of Health,” Scheltens added.