Alzheimer’s Disease Composite Score: a Post-Hoc Analysis Using Data from the LipiDiDiet Trial in Prodromal Alzheimer’s Disease
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As research evolves in prodromal AD, the need to validate sufficiently sensitive outcome measures, e.g. the Alzheimer’s Disease Composite Score (ADCOMS) is clear. In the LipiDiDiet randomized trial in prodromal AD, cognitive decline in the study population was much less than expected in the timeframe studied. While the primary composite endpoint was insufficiently sensitive to detect a difference in the modified intention to treat population, the per-protocol population showed less decline in the active than the control group, indicating better treatment effects with regular product intake. These results were further strengthened by significant benefits on secondary endpoints of cognition and function, and brain atrophy. The present post-hoc analysis investigated whether ADCOMS could detect a difference between groups in the LipiDiDiet population (138 active, 140 control). The estimated mean change in ADCOMS from baseline (standard error) was 0.085 (0.018) in the active and 0.133 (0.018) in the control group; estimated mean treatment difference −0.048 (95% confidence intervals −0.090, −0.007; p=0.023), or 36% less decline in the active group. This suggests ADCOMS identified the cognitive and functional benefits observed previously, confirming the sensitivity of this composite measure.
Key wordsAlzheimer’s disease prodromal cognitive function nutrients Souvenaid Fortasyn
We thank all participants enrolled in the study and their families; all members of the LipiDiDiet clinical study group; all investigators and on-site study staff for their efforts in the conduct of the field work.
Funding: The research leading to these results was mainly funded by the European Commission under the 7th framework program of the European Union (grant agreement number 211696). Additional funding was provided by the EU Joint Program — Neurodegenerative Disease Research (MIND-AD grant); Kuopio University Hospital, Finland (EVO/VTR grant); and Academy of Finland (grant 287490). These funders had no role in the design and conduct of the study; in the collection, analysis, and interpretation of data; in the preparation of the manuscript; or in the review or approval of the manuscript. This post-hoc analysis was funded by Danone Nutricia Research and performed by Pentara Corporation. The corresponding author had final responsibility for the decision to submit for publication.
Ethical standards: The study was approved by ethics committees of all sites and done in accordance with the Declaration of Helsinki and International Conference on Harmonization Good Clinical Practice guidelines.
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