Background/Objectives: Mild cognitive impairment (MCI) is characterized by a decline in cognitive functions while the ability to perform daily activities remains intact. This pathological condition is a recognized as risk factor for dementia-related disorders, and the current lack of therapies is the critical issue. Our preclinical studies indicated that a formulation (named GeNeurofil™) exhibited a synergistic neuroprotective effect in an animal model of amyloid beta toxicity. Therefore, the present study aimed to evaluate the efficacy of GeNeurofil™ in patients with mild cognitive impairment. Subjects/Methods: A six-months, randomized, double-blind, placebo-controlled pilot trial (retrospectively registered on ISRCTN registry-number ISRCTN11405046-01/07/2026) was performed enrolling 54 patients with mild to moderate MCI (Clinical Dementia Rating Scale ranging from 0.5 to 2). Patients, concurrently maintained under their usual medications, received either the GeNeurofil™ (0.7 mL × 3/day) or an identical placebo (0.7 mL × 3/day) for six months. The psychometric assessments were performed using the Mini Mental State Examination (MMSE) tests and depressive symptoms were evaluated with the Zung Test. Plasma samples were analyzed for NfL and p-TAU. Results: After six months of treatment, GeNeurofil™ supplementation improved CDR, MMSE, and Zung scores. Furthermore, the treatment reduced plasmatic levels of light neurofilaments (NfL) and phosphorylated Tau protein (p-TAU) compared to placebo. Conclusion: Our findings indicate that six months of supplementation with GeNeurofilTM might represent a helpful adjuvant strategy for cognitive impairment. GeNeurofil™ nutraceutical supplementation demonstrates a favorable safety profile, however given the exploratory nature of this pilot feasibility trial, these preliminary findings will further followed by confirming definitive clinical efficacy in larger clinical trials.
The impact of GeNeurofil™ nutraceutical supplementation on psychometric assessment and biomarkers of neurodegeneration in cognitive impaired patients: a pilot study
Trabace, Luigia;Morgese, Maria Grazia;Tucci, Paolo;Agosti, Lisa Pia;
2026-01-01
Abstract
Background/Objectives: Mild cognitive impairment (MCI) is characterized by a decline in cognitive functions while the ability to perform daily activities remains intact. This pathological condition is a recognized as risk factor for dementia-related disorders, and the current lack of therapies is the critical issue. Our preclinical studies indicated that a formulation (named GeNeurofil™) exhibited a synergistic neuroprotective effect in an animal model of amyloid beta toxicity. Therefore, the present study aimed to evaluate the efficacy of GeNeurofil™ in patients with mild cognitive impairment. Subjects/Methods: A six-months, randomized, double-blind, placebo-controlled pilot trial (retrospectively registered on ISRCTN registry-number ISRCTN11405046-01/07/2026) was performed enrolling 54 patients with mild to moderate MCI (Clinical Dementia Rating Scale ranging from 0.5 to 2). Patients, concurrently maintained under their usual medications, received either the GeNeurofil™ (0.7 mL × 3/day) or an identical placebo (0.7 mL × 3/day) for six months. The psychometric assessments were performed using the Mini Mental State Examination (MMSE) tests and depressive symptoms were evaluated with the Zung Test. Plasma samples were analyzed for NfL and p-TAU. Results: After six months of treatment, GeNeurofil™ supplementation improved CDR, MMSE, and Zung scores. Furthermore, the treatment reduced plasmatic levels of light neurofilaments (NfL) and phosphorylated Tau protein (p-TAU) compared to placebo. Conclusion: Our findings indicate that six months of supplementation with GeNeurofilTM might represent a helpful adjuvant strategy for cognitive impairment. GeNeurofil™ nutraceutical supplementation demonstrates a favorable safety profile, however given the exploratory nature of this pilot feasibility trial, these preliminary findings will further followed by confirming definitive clinical efficacy in larger clinical trials.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
