The study enrolled 54 people with mild-to-moderate cognitive impairment in a six-month randomised, double-blind, placebo-controlled trial. Participants continued their usual medication and received either GeNeurofil™ or placebo three times daily.
The authors report favourable changes in CDR, MMSE and Zung scores and reductions in plasma neurofilament light and phosphorylated tau compared with placebo. Combining psychometric measures with biomarkers makes the design noteworthy for brain-health development.
For R&D, the message is not that definitive efficacy has been established. It is that a nutraceutical formulation can be assessed through a broader endpoint architecture than subjective perception alone.
The paper describes the trial as exploratory and preliminary. Sample size, retrospective registration and the need for independent replication require restraint before translating the findings into claims, populations or different formulations.
Brain health remains a high-interest industrial field; the study illustrates the value of connecting cognitive outcomes with biomarkers without pre-empting confirmatory trials.
A 54-participant feasibility pilot, retrospectively registered. Larger, preregistered and independently replicated studies are required.
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Read the original source · European Journal of Clinical Nutrition ↗