Unexpected results from a phase 3 trial exploring the effect of multivitamins and cognition have now been published.
Findings from a phase 3 study show that daily use of multivitamins, but not cocoa, is linked to a significantly slower rate of age-related cognitive decline.
Originally presented last November at the 14th Clinical Trials on Alzheimer disease (CTAD) conference and reported by Medscape Medical News At the time, this is the first large-scale long-term randomized controlled trial examining the effects of cocoa extract and multivitamins on global cognition. The main focus of the trial was cocoa extract, which previous studies suggest may preserve cognitive function. Analysis of the effect of multivitamins was a secondary outcome.
Dr Laura Baker
Showing vitamins, but not cocoa, was beneficial is the exact opposite of what the researchers expected. Still, the results offer an exciting new direction for future studies, said lead researcher Laura D. Baker, PhD, professor of gerontology and geriatric medicine at Wake Forest School of Medicine, Winston-Salem, North Carolina. Medscape Medical News.
“This study prompted us to note a pathway for possible cognitive protection,” Baker said. “Without this study, we never would have pursued that path.”
The full results were Posted online today in Alzheimer’s and Dementia.
unexpected effect
the COSMOS-Mind The study is a substudy of a larger main trial called COSMOS. investigated the effects of cocoa extract and a standard multivitamin-mineral (MVM) on cardiovascular and cancer outcomes in more than 21,000 older participants.
In COSMOS-Mind, researchers tested whether daily intake of cocoa extract versus placebo and a multivitamin-mineral versus placebo improved cognition in older adults.
More than 2,200 participants aged 65 years and older were enrolled and followed for 3 years. They completed tests over the phone at baseline and annually to assess memory and other cognitive abilities.
Results showed that cocoa extract had no effect on global cognition compared with placebo (mean z-score, 0.03; P = .28). However, daily use of multivitamins showed significant benefits in global cognition versus placebo (z mean, 0.07, P = .007).
The beneficial effect was more pronounced in participants with a history of cardiovascular disease (no history 0.06 vs. history 0.14; P = .01).
The researchers found similar protective effects for memory and executive function.
Baker suggested that one possible explanation for the positive effects of multivitamins could be the increase in essential micronutrients and minerals they provided.
“With nutrient deficient diets plus a high prevalence of cardiovascular disease, diabetes, and other medical comorbidities that we know affect the bioavailability of these nutrients, we may be dealing with older adults who are suboptimal in terms of essential micronutrients and minerals. ,” she said.
“Even suboptimal levels of essential micronutrients and minerals can have significant consequences for brain health,” he added.
more research needed
As intriguing as the results may be, more work is needed before the findings can affect nutritional guidance, according to Maria C. Carrillo, PhD, chief scientific officer of the Alzheimer’s Association.
“While these results encourage the Alzheimer’s Association, we are not ready to recommend the widespread use of a multivitamin supplement to reduce the risk of cognitive decline in older adults,” Carrillo said in a statement.
“For now, and until more data is available, people should talk to their health care providers about the benefits and risks of all dietary supplements, including multivitamins,” he added.
Baker agreed, noting that the study was not designed to measure multivitamin use as a primary outcome. Additionally, nearly 90% of the participants were non-Hispanic white, which is not representative of the general demographics of the population.
The researchers are now designing another, larger trial that would include a more diverse group of participants. It will be specifically aimed at learning more about how and why multivitamins appear to offer a protective effect on cognition, Baker noted.
The study was funded by the National Institute on Aging at the National Institutes of Health. Baker and Carrillo report no relevant financial conflicts of interest.
Alzheimer’s dementia. Published online on September 14, 2022. Text complete
Kelli Whitlock Burton is a reporter for Medscape Medical News who covers psychiatry and neurology.
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