Nestlé Health Science, a unit of Nestlé, has launched the COGNIKET-MCI trial of its nutritional product BrainXpert in people with mild cognitive impairment (MCI).
The trial featuring nearly 380 people is being conducted in Italy, Spain, Germany, France, Switzerland, the US, and the UK.
It aims to investigate BrainXpert’s potential benefits as a specialised ketogenic product, serving as an alternative energy source to glucose and supporting brain cell function.
The study builds upon the previous BENEFIC trial held in 2020s. It will be a collaborative effort with MCI experts from Europe and North America.
BrainXpert has been developed by Nestlé Health Science for special medical purposes to aid cognitive function in individuals with MCI.
It features ingredients such as medium-chain triglycerides that can be used as an alternative brain energy source. BrainXpert also has B-vitamins and other ingredients to support the functionality of brain cells.
Participants of the COGNIKET-MCI trial will undergo various cognitive assessments throughout the trial. These include the Preclinical Alzheimer Cognitive Composite (PACC), which is capable of detecting subtle cognitive changes.
Initially, participants will go through a randomised placebo-controlled phase for 12 months, followed by an open-label part for the subsequent period of six months.
In addition, COGNIKET-MCI will evaluate BrainXpert’s effects on accelerated cognitive decline, dementia progression, quality of life, and quality of sleep.
Nestlé Health Science CEO Anna Mohl said: “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 management of people with MCI.
“This trial may transform how MCI is managed.”
According to Nestlé Health Science, randomisation of patients has begun in the trial, which will continue recruiting individuals across nearly 30 sites. The completion of the trial is anticipated in 2026-2027.
