Crowborough

Researchers are evaluating the safety and effectiveness of combining KarXT and KarX-EC as a treatment for psychosis associated with Alzheimers disease. This Phase 3 randomized, double-blind, placebo-controlled trial aims to address psychotic symptoms such as hallucinations and delusions in patients aged 55 to 90 diagnosed with Alzheimers disease according to recent criteria. The study is sponsored by Bristol-Myers Squibb and uses a parallel group design to compare the investigational drug combination against placebo. Participants will be randomly assigned to receive either the combination of KarXT plus KarX-EC or a matching placebo, with specified doses given on set days. The treatment period lasts approximately 14 weeks, during which safety and efficacy are closely monitored. The trial assesses changes from baseline in neuropsychiatric symptoms and other clinical measures using standardized scales and questionnaires. During the study, participants will undergo various assessments including clinical evaluations, laboratory tests, brain imaging review, and symptom rating scales such as the Neuropsychiatric Inventory-Clinician and Clinical Global Impressions-Severity. Researchers will also monitor adverse events and other health indicators up to about week 14. The total participation duration spans from screening through treatment completion and safety follow-up to evaluate the overall impact and safety profile of the treatments.

Researchers are studying the effects of a nutritional intervention combining ketogenic medium-chain triglycerides kMCT and B-vitamins on cognitive function in older adults diagnosed with mild cognitive impairment MCI. This randomized, double-blind, placebo-controlled trial aims to evaluate how this nutritional approach impacts cognitive performance over a 12-month period. The study is sponsored by Socit des Produits Nestl and involves multiple centers and countries. Participants will be randomly assigned to receive either BrainXpert, a dietary supplement containing 15 g of kMCT and B-vitamins in powder form, or a placebo consisting of a calorie-equivalent, non-ketogenic high-oleic acid sunflower oil powder. Both are provided in sachetstickpack format without preservatives, flavors, sweeteners, or colorants. The intervention is administered daily during the study period. During the trial, participants and their informants will attend clinic visits at baseline, 12 months, and 18 months. Cognitive function will be assessed using tools such as the Preclinical Alzheimers Cognitive Composite PACC, Montreal Cognitive Assessment MoCA, Wechsler Memory Scale, and Mini-Mental State Examination MMSE. Safety and tolerability will also be monitored throughout the 12 months. The study includes adherence assessments and requires participants to comply with study procedures and medication restrictions.