A Minnesota researcher has found that vitamin E in large doses can significantly slow the progression of life-altering symptoms during the mild to moderate stages of Alzheimer’s disease — a finding that could lead to savings of untold millions of dollars in caregiving costs.
The five-year study, published Tuesday in the Journal of the American Medical Association (JAMA), was centered at the Minneapolis Veterans Medical Center.
The researchers decided they didn’t need to quantify the precise savings, “because vitamin E [is] so cheap that if there was any benefit, it would be sort of obvious,” said the principal investigator, Dr. Maurice W. Dysken, 71, of Minneapolis.
Caring for the 5.2 million Americans living with all forms of dementia cost $203 billion in 2013, according to the Alzheimer’s Association, including $142 billion in outlays by the taxpayer-funded Medicare and Medicaid programs.
In Minnesota alone there were about 243,000 people caring for more than 95,000 dementia patients over age 65, the association estimates.
With the population aging, those numbers are likely to rise substantially.
Dysken’s findings, taken together with previous research, indicates that vitamin E should be considered for Alzheimer’s and other dementia patients, according to a leading researcher at Mayo Clinic in Rochester.
“It’s not going to be a wonder drug by any means, but it gives us another option for people who are symptomatic with the disease,” said Dr. Ronald Peterson. “If people stay more functional for a longer period of time, that’s positive.”
The $11 million, randomized study was conducted at 14 medical centers around the county from August 2007 to September 2012 by the Department of Veterans Affairs (VA) Cooperative Studies Program. It involved 613 patients with mild to moderate Alzheimer’s disease who were assigned to one of four groups.
One group took 2,000 International Units (IU) of vitamin E a day. Another took a drug called memantine, which is approved for use in moderately severe cases. Another took both. And another got a placebo.
Researchers then measured the amount of caregiving patients required as the disease eroded their independent “activities of daily living.” Researchers also used secondary measures, including cognitive and behavioral tests.
“We thought the most important thing to look at was function,” said Dysken, who recently retired after running the Minneapolis VA’s Geriatric Research Education and Clinical Center for 19 years.
The study found that the intensive vitamin E therapy was safe and resulted in a 19 percent improvement in clinical symptom progression as compared with the placebo. That equates to about a six-month delay over the average two-year follow-up period.
Physicians don’t need approval from the Food and Drug Administration to start prescribing therapeutic doses of vitamin E.
“I think the thing they will look at is whether a delay of six months over two years in mild-to-moderate patients is really worthwhile,” Dysken said. “Early in the illness, when patients are functioning well and quality of life is good, I think a patient and caregiver would say ‘yeah, let’s go for it.’ I think much later on in the illness … there’s no need to prolong or delay progression at that point.”
An accompanying editorial in JAMA called the results “modest” but encouraging, and praised the study for its size, duration and absence of commercial motives.
Dr. Denis A. Evans, a professor at Rush University Medical Center in Chicago, wrote that the results would have been more convincing had vitamin E showed improvements on secondary measures, such as cognitive tests, but it did not. In an interview, Evans noted that a 2005 meta-analysis showed “a real possibility” that taking more than 400 IUs of vitamin E could increase the risk of premature death.
“On [the] other hand, this is a lousy disease, and certainly one is entitled to consider taking chances with it,” Evans said. Dysken noted that the meta-analysis was not specific to patients with Alzheimer’s.
Peterson agreed. Most patients in that study had cardiovascular disease. He said the studies each found that high-dose vitamin E therapy was safe for Alzheimer’s patients generally. Even so, the risk should be discussed with patients and caregivers, he said.
The idea for the study grew out of an article published in the New England Journal of Medicine in 1997. Author Mary Sano, director of Alzheimer’s Research at Mount Sinai School of Medicine, reported that 2,000 IU of vitamin E delayed progression of symptoms in patients with moderately severe Alzheimer’s. Dysken wanted to see whether the same was true for patients with mild to moderate symptoms.
Peterson said Dysken’s findings, taken together with Sano’s work, indicate that vitamin E should be considered for Alzheimer’s and other dementia patients.
Don’t know how it works
Asked how vitamin E might be working, Dysken laughed and said he had no idea.
“We describe it of course as an antioxidant, but I’m hard-pressed to give you any reasonably cogent theory about why it might be doing anything in the brains of patients with Alzheimer’s,” he said.
He noted that Peterson of the Mayo Clinic has published a study that found that vitamin E had no significant effect in delaying the conversion from Mild Cognitive Impairment to Alzheimer’s.
“That’s really important to emphasize,” Dysken said. “This [VA] study really shows benefit for patients with the diagnosis. This is not a prevention study.”
Dysken said vitamin E’s effects were equivalent to currently available drugs called acetylcholinesterase inhibitors, which have been shown to slow the progression of symptoms.