DSM’s Quali-E slows disease
DSM’s Quali-E Vitamin E delayed functional decline in patients with mild to moderate Alzheimer’s Disease (AD) by 19% or a clinically meaningful delay in progression of 6.2 months over the follow-up period compared to placebo. Further, daily high dose (2000 IU/day) supplementation of Vitamin E for a long period of time (2.3 years) did not raise safety concerns.
Supplementation with high levels of Vitamin E (2000 IU/d of DL-alpha tocopheryl acetate) among patients with mild to moderate Alzheimer’s Disease resulted in slower functional decline when compared with placebo according to a new study, entitled “Effects of Vitamin E and Memantine on Functional Decline in Alzheimer’s Disease” released in the prestigious Journal of the American Medical Association.
This study, independently designed by the Department of Veterans Affairs Cooperative Studies Program, was a double-blind, placebo-controlled, randomized clinical trial involving 613 patients with mild to moderate Alzheimer’s Disease. Participants received either 2000 IU/d of Vitamin E, 20 mg/d of memantine (a drug under investigation for its role in the treatment of dementia and Alzheimer’s), the combination of both, or placebo. DSM Nutritional Products provided the Vitamin E (Quali-E) for this study.
Within the Vitamin E only group, Vitamin E supplementation delayed the rate of clinical progression of Alzheimer’s Disease by 19% or 6.2 months over the follow-up period and reduced the amount of caregiver time by nearly two hours per day. The placebo group lost approximately 3 units more on the ADCS-ADL inventory than the Vitamin E supplemented group. According to the study authors, “a loss of this magnitude could translate into either the complete loss of being able to dress or bathe independently”. Decline of function in Alzheimer’s Disease is increasingly recognized as an important determinant of patient quality of life, and has significant social and economic costs. In addition, the study, one of the largest and longest clinical trials in patients with mild to moderate Alzheimer’s Disease, did not observe any significant safety concerns (including mortality) as had been suggested by a 2005 meta-analysis of supplementation trials with 400 IU or higher of Vitamin E.
It should be noted that the vitamin E group was superior to the drug which was investigated in parallel in decelerating progression of Alzheimer Disease – and actually the author of the editorial commented the on findings:
Vitamin E is an essential antioxidant nutrient that helps protect cell membranes by neutralizing free radicals, and also helps to maintain the immune system, support the health of red blood cells, and maintain a healthy circulatory system. Vitamin E is found in all body tissues and is important for their health and proper functioning. Currently, more than 90% of Americans and 75% of British people do not consume enough vitamin E from food. The current Recommended Dietary Allowance (RDA) for vitamin E for healthy adults is 15 mg/day (33 IU of dl-alpha-tocopherol).