EffEct of a mEdical food on body mass indEx and activitiEs of daily living in patiEnts with alzhEimEr’s disEasE: sEcondary analysEs from a randomizEd, controllEd trial

to investigate the effect of a medical food (souvenaid) on body mass index (Bmi) and functional abilities in patients with mild alzheimer’s disease (ad). Design/setting/participants/intervention /measurements: these analyses were performed on data from a 12-week, double-blind, randomized, controlled, multicenter, proof-of-concept study with a similarly designed and exploratory 12-week extension period. Patients with mild ad (mini-mental state examination score of 20–26) were randomized to receive either the active product or an iso-caloric control product. While primary outcomes included measures of cognition, the 23-item alzheimer’s disease cooperative study-activities of daily living (adcs-adl) scale was included as a secondary outcome. Both adcs-adl and Bmi were assessed at baseline and Weeks 6, 12 and 24. data were analyzed using a repeated-measures mixed model. Results: Overall, data suggested an increased Bmi in the active versus the control group at Week 24 (itt: p = 0.07; PP: p = 0.03), but no treatment effect on adcs-adl was observed. However, baseline Bmi was found to be a significant treatment effect modifier (itt: p = 0.04; PP: p = 0.05), and an increase in adcs-adl was observed at Week 12 in patients with a ‘low’ baseline Bmi (itt: p = 0.02; PP: p = 0.04). Conclusions: these data indicate that baseline Bmi significantly impacts the effect of souvenaid on functional abilities. in addition, there was a suggestion that souvenaid increased Bmi.