Alzheimer’s Disease Composite Score: a Post-Hoc Analysis Using Data from the LipiDiDiet Trial in Prodromal Alzheimer’s Disease - 21/11/24

Doi : 10.14283/jpad.2019.33 
Suzanne B. Hendrix 1, , H. Soininen 2, 3, A.M.J. van Hees 4, N. Ellison 1, P.J. Visser 5, 6, A. Solomon 2, 7, 8, A. Attali 4, K. Blennow 9, 10, M. Kivipelto 2, 7, 8, T. Hartmann 11, 12
1 Pentara Corporation, 2180 Claybourne Avenue, 84109, Salt Lake City, UT, USA 
2 Department of Neurology, Institute of Clinical Medicine, University of Eastern Finland and Kuopio University Hospital, Kuopio, Finland 
3 Neurocenter, Department of Neurology, Kuopio University Hospital, Kuopio, Finland 
4 Danone Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, the Netherlands 
5 Department of Psychiatry and Neuropsychology, Alzheimer Center Limburg, University of Maastricht, Maastricht, the Netherlands 
6 Department of Neurology, Alzheimer Center, VU University Medical Center, Amsterdam, the Netherlands 
7 Department of Clinical Geriatrics, NVS, Karolinska Institutet, Huddinge, Sweden 
8 Clinical Trials Unit, Department of Geriatric Medicine, Karolinska University Hospital, 14152, Huddinge, Sweden 
9 Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, The Sahlgrenska Academy at University of Gothenburg, Mölndal, Sweden 
10 Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden 
11 Deutsches Institut für Demenz Prävention (DIDP), Medical Faculty, Saarland University, Homburg, Germany 
12 Department of Experimental Neurology, Saarland University, Homburg, Germany 

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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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Key words : Alzheimer’s disease, prodromal, cognitive function, nutrients, Souvenaid, Fortasyn


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 A correction to this article is available at s42414-019-0001-5
 An erratum to this article is available online at s42414-019-0001-5.
 An erratum to this article is available online at s42414-019-0001-5.


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Vol 6 - N° 4

P. 232-236 - Ottobre 2019 Ritorno al numero
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