What is BrainXpert studying for mild cognitive impairment?

BrainXpert is being studied to see if a nutritional supplement containing ketogenic medium-chain triglycerides and B-vitamins can affect cognitive function in older adults with mild cognitive impairment. The trial is led by Société des Produits Nestlé and aims to understand how this intervention might influence memory and thinking skills.

Who may be eligible for this mild cognitive impairment clinical trial?

Adults aged 60 years or older with a clinical diagnosis of mild cognitive impairment and memory complaints longer than 3 months may be eligible. Participants must have a reliable informant and be able to comply with study requirements. The trial is open to all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this mild cognitive impairment clinical trial?

Study-related care, including the study supplement and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 60Years +

All Genders

ID06347315

COGNIKET-MCI Trial Study of Ketogenic Medium-chain Triglycerides and B-vitamins on Cognitive Functioning in Older Adults With Mild Cognitive Impairment

Led by Société des Produits Nestlé (SPN) · Updated on 2025-08-14

380

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of a nutritional intervention combining ketogenic medium-chain triglycerides kMCT and B-vitamins on cognitive functioning in older adults diagnosed with mild cognitive impairment MCI. This multi-center, multi-country, randomized, double-blind, placebo-controlled pivotal trial aims to study whether this dietary supplement can influence cognitive performance in participants aged 60 years and older who have memory complaints and meet specific diagnostic criteria for MCI. Participants will be randomly assigned to receive either BrainXpert, a dietary supplement powder containing 15 g of kMCT and B-vitamins B3, B6, B9folic acid, and B12, or a placebo powder consisting of high-oleic acid sunflower oil without added vitamins. Both interventions come in powder sachetsstickpacks of 25 g. The trial includes multiple visits over an 18-month period, with key assessments at 12 and 18 months to monitor cognitive changes and safety. During the study, participants and their trial informants will attend scheduled clinic visits to undergo cognitive tests including the Preclinical Alzheimers Cognitive Composite PACC, Montreal Cognitive Assessment MoCA, Wechsler Memory Scale, and Mini-Mental State Examination MMSE. Researchers will also monitor safety and tolerability through emergent adverse event tracking. The trial requires participants to comply with protocol procedures, including discontinuing certain medications before and during the study, and to have an informant who can provide reliable information throughout the trial duration.

CONDITIONS

Brief Title

Evaluation of the Effects of a Nutritional Intervention of Ketogenic Medium-chain Triglycerides and B-vitamins on Cognitive Functioning in Older Adults With Mild Cognitive Impairment (COGNIKET-MCI)

Who Can Participate

Age: 60Years +

All Genders

Eligibility Criteria

You may qualify if you...

Have signed the informed consent form.
Be aged 60 years or older at screening.
Have memory or cognitive complaints lasting more than 3 months.
Have a clinical diagnosis of mild cognitive impairment with specific neuropsychological test results.
Have full autonomy for daily living based on IADL-Lawton scale scores.
Have an available trial informant willing to attend key clinic visits.
Trial informant must have sufficient contact with the participant.
Participants and informants must have adequate reading, writing, vision, and hearing abilities.
Have a Clinical Dementia Rating (CDR) global score of 0 to 0.5 at screening.
Sexually active females of childbearing potential must use two highly effective contraceptive methods or remain abstinent during and 30 days after the trial.
Females of childbearing potential must have a negative pregnancy test before randomization.
Be able to comply with protocol requirements.
Willing and able to stop prohibited medications before and during the trial as required.

You will not qualify if you...

Diagnosis of major neurocognitive disorder or dementia at enrollment.
Mild cognitive impairment related to specific causes like concussion, COVID-19, or other neurodegenerative diseases.
History of COVID-19 within 120 days before screening or recent vaccination.
Recent changes or planned use of medications affecting cognition.
Likely need for prohibited medications during the trial.
History of alcohol or substance use disorder that may interfere with participation.
Symptoms of depression or anxiety above specified thresholds.
Known active infections like HIV, hepatitis B or C.
History of epilepsy or seizures except specific childhood or withdrawal seizures.
Poor general health or recent significant weight loss or infection.
Cancer diagnosis in past 2 years excluding certain skin or early-stage cancers.
Significant kidney disease or uncontrolled hypertension.
Uncontrolled thyroid disease.
Recent or planned surgery requiring general anesthesia.
Poorly regulated diabetes or certain diabetes treatments.
Vitamin B12 deficiency or current high-dose B-vitamin supplementation.
Very high triglyceride levels.
Inability to comply with protocol procedures.
Personal or hierarchical connection to research team.
Shift work involving night shifts.
Pregnancy or breastfeeding.
Following ketogenic or similar diets or taking ketone-related supplements.
Allergy or intolerance to study ingredients such as milk proteins.

Research Team

Monique Bunyan

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here