Evaluation of Clinical Meaningfulness of Fortasyn Connect in Terms of “Time Saved” - 21/11/24
Abstract |
Assessment of meaningfulness in randomized clinical trials (RCTs) in Alzheimer’s disease (AD) is challenging, particularly in early disease. Converting clinical outcomes to disease progression time allows assessment of treatment effects using a metric that is understandable and meaningful: time. We demonstrate time savings assessments using meta time component tests (TCTs) in the LipiDiDiet multinutrient RCT. Dietary patterns are important for dementia prevention, likely due to individual cumulative nutrient effects. LipiDiDiet used a multinutrient (Fortasyn Connect) formulation in patients with prodromal AD, benefitting cognition (5-item composite NTB, effect 0.089), cognition and function (CDR-SB, −0.605), and slowing hippocampal atrophy (0.122 cm3). Meaningfulness of point differences is unclear. However, a combination TCT showed 9-month disease time savings at 24 months (38% slowing of disease time): 9.0, 10.5, and 7.2 months for NTB, CDR-SB, and hippocampal volume, underscoring the value of TCTs in AD RCTs and the need for continued validation of this approach.
Il testo completo di questo articolo è disponibile in PDF.Key words : Time saved, Alzheimer’s disease and mild cognitive impairment, Fortasyn Connect, Souvenaid, clinical relevance and meaningfulness, nutritional supplements
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Vol 11 - N° 4
P. 992-997 - Agosto 2024 Ritorno al numeroBenvenuto su EM|consulte, il riferimento dei professionisti della salute.