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Alzheimer's Disease Composite Score: a Post-Hoc Analysis Using Data from the LipiDiDiet Trial in Prodromal Alzheimer's Disease

Journal article
Authors S. B. Hendrix
H. Soininen
A. M. J. van Hees
N. Ellison
P. J. Visser
A. Solomon
A. Attali
Kaj Blennow
M. Kivipelto
T. Hartmann
Published in Jpad-Journal of Prevention of Alzheimers Disease
Volume 6
Issue 4
Pages 232-236
ISSN 2274-5807
Publication year 2019
Published at Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry
Pages 232-236
Language en
Links dx.doi.org/10.14283/jpad.2019.33
Keywords Alzheimer's disease, prodromal, cognitive function, nutrients, Souvenaid, Fortasyn, criteria
Subject categories Neurosciences

Abstract

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.

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