Nestlé Health Science kicks off clinical trial on mild cognitive impairment
14 Jun 2024 --- Nestlé Health Science is investigating the benefits of a specialized ketogenic product, BrainXpert, on mild cognitive impairment (MCI). This nutritional product is intended to be used as a food for special medical purposes or medical food to support cognitive function for people with MCI. The trial recently randomized its first participant and will continue to enroll people across around 30 sites.
According to the company, when people age or have MCI, their brains are less able to use glucose as an energy source, which may negatively affect brain function. The brain uses around 20% of a person’s total daily energy requirement to maintain all functions, such as supporting memory and thinking. Glucose is a key energy source for the brain.
The trial will investigate whether BrainXpert could be an alternative fuel source to glucose and provide brain cell support. It will include approximately 380 people with MCI from seven countries: Italy, Spain, France, Germany, Switzerland, the UK and the US.
“This is the largest nutritional placebo-controlled interventional trial of its kind and signals the commitment of Nestlé Health Science to advance the understanding of the management of people with MCI,” says Anna Mohl, CEO of Nestlé Health Science. “This trial may transform how MCI is managed.”
BrainXpert contains medium-chain triglycerides, which can be used as an alternative brain energy source, and B vitamins, which support brain cell functionality.
Cognitive-supporting nutrition
MCI shows itself as a decline in memory and thinking problems that are more pronounced than expected at a person’s age. The condition affects around 20% of people over 65 and 40% over 90. Even though people with MCI can typically maintain daily activities, they have an increased risk of developing dementia.
Earlier this year, a report published by the Gerontological Society of America revealed that as much as 40% of dementia diagnoses can be averted by modifying eating behavior. Meanwhile, cognition-boosting ingredients are emerging as consumers of all ages looking to enhance their brain power.
Hans-Juergen Woerle, MD, chief scientific and medical officer of Nestlé Health Science, explains: “MCI is an intermediate clinical state between healthy aging and dementia. Expanding our understanding of how to better optimize, or preserve, cognitive function is instrumental to enable independent living and increase health span.”
Participants in the COGNIKET-MCI trial will be assessed with several cognitive tests, such as the Preclinical Alzheimer Cognitive Composite, which can capture subtle cognitive decline. For the first 12 months, trial participants will enter a randomized placebo-control phase, followed by a six-month open-label part.
The trial will also evaluate how BrainXpert can impact accelerated cognitive decline, progression to dementia, quality of life and sleep quality.
It will expand on an earlier, successful, smaller trial. The trial, designed in collaboration with an academic group of MCI experts from Europe and North America, is expected to conclude in 2026–2027.
Edited by Jolanda van Hal
