COGNIKET-MCI Trial
Research type
Research Study
Full title
COGNIKET-MCI Trial: A prospective, randomized, double-blind, placebo-controlled, multi-center, multi-country, pivotal trial to study the effects of a nutritional intervention of ketogenic medium-chain triglycerides (kMCT) and B-vitamins on cognitive functioning in older adults with Mild Cognitive Impairment
IRAS ID
334010
Contact name
Karim Jamali
Contact email
Sponsor organisation
Nestlé Health Science
Duration of Study in the UK
1 years, 10 months, 23 days
Research summary
Mild Cognitive Impairment (MCI) is an intermediate clinical state between healthy aging and dementia. Research on how to best manage MCI is ongoing, and current management of MCI is based on a holistic, multidisciplinary approach depending on the underlying cause.
Société des Produits Nestlé has developed a nutritional formulation, called BrainXpert intended for dietary management of people with MCI. BrainXpert is made up of molecules that your body converts to energy-substrates for the brain (called “ketones”) and B vitamins (B3, B6, B9/folic acid, and B12), which are important co-factors for normal cell functioning, including the brain. It is thought the combination of these two principles will enhance the effects on cognitive function, hereby resulting in improved brain energy metabolism.The main purpose of this trial is to learn about the efficacy of BrainXpert and understand its long-term tolerability, when compared with placebo, when taken twice daily over 12 months in older adults with mild cognitive impairment.
This trial has a screening visit and 2 intervention periods: a 52-week blinded intervention period and a 26-week open-label intervention period. During the intervention period participants will have 3 onsite visits (V1, V2, V3), and only 1 onsite visit (V4) during the open-label period. The overall duration of treatment with nutritional formulation is approximately 18 months.
During the blinded intervention period, participant will have an equal chance (1 in 2) of receiving either BrainXpert or placebo. After Visit 3, the open-label intervention period will begin, and all participants will receive BrainXpert. For the first 2 weeks in both the intervention and open-label periods, participants dosage will be gradually increased from 1 tablespoon to 4 tablespoons (i.e., 1 sachet/stick pack).
The goal is to have 380 trial participants taking part in this trial globally, and approximately 32 taking part in UK.
REC name
Wales REC 6
REC reference
24/WA/0018
Date of REC Opinion
23 Jan 2024
REC opinion
Favourable Opinion