Medical Food Linked to Memory Improvement in Mild Alzheimer’s
Administration of a medical food designed to improve synaptic dysfunction is associated with continuous memory improvement in patients with mild Alzheimer’s disease (AD), new research shows.
Presented here at the Alzheimer’s Association International Conference (AAIC) 2012, results from an open-label extension (OLE) trial of a medical nutrition product (Souvenaid, Nutricia/Danone) showed that memory performance continued to improve in drug-naïve patients with mild AD for up to 48 weeks.
At 48 weeks, memory of participants in the group randomly assigned to receive active treatment and who continued to receive Souvenaid in the OLE part of the study improved even further.
“There was no ceiling effect,” he said.
Furthermore, study participants who were in the placebo group in the randomized controlled period of the trial and who were switched to the active treatment in the OLE study also experienced significant memory improvement. The findings also show that Souvenaid is “very safe and well tolerated”
Developed by researchers at the Massachusetts Institute of Technology, in Boston, Souvenaid is a medical nutrition test product designed to support synapse formation.
“It is medical nutrition, and we think it may offer a new approach — a dietary management approach, if you like — for people with very early AD,” Dr. Scheltens told reporters attending a press briefing.
Synapse loss, he said, is an early event in the AD process. By providing the nutritional precursors and cofactors for synapse formation, researchers hope to support the formation and function of synapses.
The once-a-day drink contains a patented nutrient combination with the following ingredients:
· Eicospentaenoic acid, 300 mg
· Docosahexaenoic acid, 1200 mg
· Phospholipids 106 mg
· Choline, 400 mg
· Uridine monophosphate, 625 mg
· Vitamin E (alpha-tocopherol), 40 mg
· Selenium, 60 µg
· Vitamin B12, 3 µg
· Vitamin B6, 1 µg
· Folic acid, 400 µg
Approximately 30% of the patients who went into the open-label follow-up actually began therapy on cholinesterase inhibitors. The researchers found no difference in the effect of Souvenaid with our without these drugs. The effect size of Souvenaid was on the order of cholinesterase inhibitors, which are 1 of 2 classes of drugs used to treat AD symptoms. There were virtually no side effects associated with Souvenaid, the medical food had a more favorable risk/benefit ratio vs cholinesterase inhibitors.
Souvenaid will launch in Europe sometime this fall. It requires a diagnosis of mild AD and a prescription from a physician. It is as yet uncertain whether its cost will be reimbursed by insurers. Exactly when it will be launched in the United States is not clear.
Reported in Mescape Psychiatry
Analysis by Dr. Reinhardt:
Big Pharma has worked out a clever way of increasing profits, with the FDA’s acceptance of medical Food. “The term medical food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) is a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” (FDA)
While continually denying the effectiveness of nutritional health, they are marketing to physicians their own patented combinations. Physicians will be convinced that somehow their formulas are “special” and will prescribe, prescribe, prescribe. Pricing will, of course, provide an astounding profit, since insurance companies and Medicare will be forced into paying.
Souvenaid’s effect to “support synapse formation” can be matched over the counter by taking:
1. Vitamin B Complex
2. Fish oil (omega 3’s)
4. Vitamin E (but please use the more active gamma form rather than the synthetic alpha)
5. Brewer’s yeast (Uridine monophosphate) and
6. Lecithin (Phospholipids and Choline
Taking these 6 capsules rather than the pretend drug will save you a flotilla of money, help control medical costs, and save your body from exposure to the many artificial flavors, colors, corn sweetener, defoaming agents, stabilizers, and preservatives that are sure to be in the final Frankenstein product.
It should be noted that the nutrient levels offered in Souvenaid fall far short of what nutrition scientists are adequate. A good quality of B Complex will contain at least 100 µg of Vitamin B12, not Souvenaid’s 3 µg. The RDA of Vitamin B6 is 2 mg, and most brands have much more; Souvinaiud falls far short with only 1 µg. Souvinaid’s 40 mg of synthetic Vitamin E falls short of natural, gamma- Vitamin E, typically taken at 100 mg or 400 iu of mixed forms. Souvinaid’s Omega 3 levels are almost 3 times less than recommended.
The price for Souvinaid has not yet been released. Using Axona, another “Medical Food” as a guide, you can expect to pay about $110.00 per month, plus the cost of the doctor’s visit, assuming you do not double up on dosage to satisfy your nutrient needs.
If you do not mind taking 6 capsules per day as oppposed to an artificially flavored drink, you can buy the six over the counter supplements for around $18.14 per month!