Nutritional Intervention Studied in Cognitively Healthy Older Adults

The feasibility of a fully virtual study testing the potential effects of Souvenaid -- a once-daily multi-nutrient drink -- on cognition in healthy aging adults was discussed during a presentation the recent Alzheimer's Association International Conference.

In this exclusive MedPage Today interview, Christian J. Camargo, MD, of the University of Miami Miller School of Medicine in Florida, walks us through the trial design.

Following is a transcript of his remarks:

The REACTION trial is short for the Reducing the Effects of Aging on Cognition with Therapeutic Intervention of an Oral Multi-Nutrient. The idea behind the study is that we are taking an oral, multi-nutrient intervention -- it's actually a drink. The main ingredients are three fundamental precursors, essential precursors, that are necessary for the formation of synapses, these are the connections that exist between the brain cells, and by providing the essential precursors, the idea is that you strengthen the connections between brain cells. And that hopefully by strengthening the connectivity between brain cells, that you might actually somehow improve, and hopefully strengthen, brain function.

Here, the novelty of the study is that this is being done in healthy aging adults. The concept of this and this particular intervention, the commercialization version is sold in Europe as Souvenaid.

This has been previously done in Alzheimer's disease at different stages. There has been some exciting evidence that when this study has been applied compared to placebo in early-stage Alzheimer's disease in European trials, that individuals that take this compared to placebo have decreased atrophy, compared to placebo, in the structures that relate to memory, and have better cognitive scores compared to placebo, again, over the course of several years. That's what inspired me to do this study at even earlier stages, which is people who don't even have any clinical Alzheimer's disease, just normal aging adults.

I took individuals age 55 to 89 years old. This is a community-based sample, meaning we're not looking at individuals that meet criteria for Alzheimer's disease. We're simply looking at normal, healthy aging adults. Individuals did not meet criteria for clinical dementia, but were otherwise healthy, did not have any major neurological or other health conditions, who could be basically our parents, our uncles, or a lot of the times, even us, because like I said, 55 to 89. And we basically randomized them to either receive the intervention of interest versus placebo.

This is a feasibility study. It's a relatively small, 30 to intervention, 30 to placebo. And I reported the baseline results, which is essentially just our enrollment data for where we were up until February of earlier this year.

The novelty of it is that we were able to adapt very quickly to the coronavirus environment. We were hit by COVID, as many investigators were, right in the middle of our conducting it. And I'm happy to say that we were able to adapt the study into a fully virtual design. The only in-person interaction that we had to do for this study was the actual handoff of the interventional product, which like I said, is a nutrient drink. And that was the only handoff. This study, as we're doing right now with Zoom, was primarily conducted with this sort of teleplatform for the neuropsychological -- in other words, the sort of cognitive and memory and other assessments were done via virtual and video assessment.

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