Crowborough

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.