Aims

Objectives: LipiDiDiet¹ is a 6-year, double-blind, parallel-group, multi-center, randomized controlled clinical trial, investigating the specific multinutrient combination Fortasyn Connect in prodromal AD. The main aim of the present post-hoc analysis was to explore the effects of a 3-year multinutrient intervention on cognition and global function, and its subdomains, as captured by ADCOMS, a composite shown to be sensitive to change in individuals with prodromal AD, using data from the LipiDiDiet trial.

Methods

Methods: Of the study population of 311, 138 active and 140 control participants were applicable for ADCOMS analysis. ADCOMS was calculated using the selected items and corresponding partial least squares coefficients and the change from baseline was the outcome. LS-means over 36 months were calculated using a linear mixed model for longitudinal data that included baseline as a covariate, continuous time, and site and subject ID as a random effect.

Results

Results: A significant benefit of the active intervention was observed using the ADCOMS score over 36 months (P=0.045; 36% slowing). Changes were primarily driven by the CDR-SB (P=0.024; 36% slowing). In addition, ADAS-cog and MMSE showed trends consistent with improvement (P>0.05; 7 and 70% slowing, respectively). Sensitivity models showed similar results.

Conclusions

Conclusions: In this post-hoc analysis of the LipiDiDiet study data, the active group showed significantly less clinical decline over 36 months as measured by ADCOMS, confirming long-lasting beneficial effects of the multinutrient in a prodromal AD population. These analyses further validate ADCOMS in early AD.

¹EUFP7 N°211696 LipiDiDiet