Seven-country mild cognitive impairment trial underway

COGNIKET-MCI trial investigates how BrainXpert can provide cognitive support for people living with mild cognitive impairment

Mild cognitive impairment, a decline in memory and thinking problems that are more pronounced than expected at the person’s age, affects about 20% of people over 65 years old¹, and around 40% of people over the age of 90². While people with the condition can generally maintain daily activities, people with mild cognitive impairment (MCI) can have an increased risk of developing dementia³.

The brain uses a substantial amount, of a person’s total daily energy requirement, approximately 20%, in order to maintain all functions required, including those supporting memory and thinking. Glucose is a key source of energy for the brain, but as people age, and particularly people with MCI, the ability of the brain to use glucose becomes reduced^4,5, which may lead to a negative effect on brain function.

Nestlé Health Science is conducting a trial with approximately 380 people with MCI in seven countries – Italy, Spain, France, Germany, Switzerland, the UK, and USA

– to investigate the benefits of a specialized ketogenic product which could be an alternative fuel source to glucose, as well as provide brain cell support. The COGNIKET MCI trial (NCT06347315)⁶ will expand on 2020’s BENEFIC⁷ trial and has been designed in collaboration with an academic group of leading MCI experts from Europe and North America.

The ketogenic product being used in the trial is BrainXpert, a nutritional product developed by Nestlé Health Science, which is intended to be used as a food for special medical purpose, or medical food, to support cognitive function for people with MCI. It contains ingredients that can be used as an alternative brain energy source (medium chain triglycerides), and ingredients that support brain cell functionality (B-vitamins)^7,8.

The participants will be assessed with several cognition tests throughout the trials, including the Preclinical Alzheimer Cognitive Composite (PACC), which can capture subtle cognitive decline. They will enter a randomized placebo-control phase for the first 12 months, and then enter an open-label part for the subsequent six months.

The trial will also look at how BrainXpert can impact accelerated cognitive decline, progression to dementia, quality of life, and sleep quality.

“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,” said Anna Mohl, CEO of Nestlé Health Science. “This trial may transform how MCI is managed.”

Hans-Juergen Woerle, MD, Chief Scientific & Medical Officer of Nestlé Health Science commented that, “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.”

The trial randomized the first participant on June 7^th 2024 and will continue to enroll across approximately 30 sites. It is expected to conclude in 2026-2027. The results will be reported at scientific meetings, in scientific papers, and communicated to global community managing patients with MCI.

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About Nestlé Health Science

Nestlé Health Science, a leader in the science of nutrition, is a globally managed business unit of Nestlé. We are committed to redefining the management of health, offering an extensive portfolio of science-based consumer health, medical nutrition, pharmaceutical therapies, and vitamin and supplement brands. Our extensive research network provides the foundation for products that empower healthier lives through nutrition. Headquartered in Switzerland, we have more than 12,000 employees around the world, with products available in more than 140 countries. www.nestlehealthscience.com

Media contact:
Jacquelyn.Campo@nestle.com

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2. Plassman B et al. Prevalence of Cognitive Impairment without Dementia in the United States. Ann Intern Med. 2008;148:427–434
3. Tschanz JT, et al: Cache County Investigators: Conversion to dementia from mild cognitive disorder: the Cache County Neurology 2006; 67:229–234
4. Croteau E et A cross-sectional comparison of brain glucose and ketone metabolism in cognitively healthy older adults, mild cognitive impairment and early Alzheimer’s disease. Exp. Gerontol. 2018;107:18–26
5. Cunnane SC et Brain energy rescue: an emerging therapeutic concept for neurodegenerative disorders of ageing. Nature Reviews Drug Discovery 2020;19:609–633
6. https://classic.clinicaltrials.gov/ct2/show/NCT06347315?term=cogniket&draw=2&rank=1
7. Fortier M, et al. A ketogenic drink improves cognition in mild cognitive impairment: Results of a 6-month RCT. Alzheimers 2021; 17:543-552.
8. Li S et The preventive efficacy of vitamin B supplements on the cognitive decline of elderly adults: a systematic review and meta-analysis. BMC Geriatrics 2021;21:367