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Randomized Controlled Trial
. 2023;10(3):464-470.
doi: 10.14283/jpad.2023.29.

Combined Evidence for a Long-Term, Clinical Slowing Effect of Multinutrient Intervention in Prodromal Alzheimer's Disease: Post-Hoc Analysis of 3-Year Data from the LipiDiDiet Trial

S B Hendrix  1 , H Soininen, A Solomon, P J Visser, A M J van Hees, D S Counotte, J Nicodemus-Johnson, S P Dickson, K Blennow, M Kivipelto, T Hartmann
Affiliations
Randomized Controlled Trial

Combined Evidence for a Long-Term, Clinical Slowing Effect of Multinutrient Intervention in Prodromal Alzheimer's Disease: Post-Hoc Analysis of 3-Year Data from the LipiDiDiet Trial

S B Hendrix et al. J Prev Alzheimers Dis. 2023.

Abstract

The LipiDiDiet randomized clinical trial is evaluating the long term effects of a multinutrient intervention (Fortasyn Connect) compared with control in participants with prodromal AD. In this post-hoc analysis we used the Alzheimer's Disease Composite Score (ADCOMS) as a measure of cognition and global function, together with a global statistical test (GST) and Bayesian hierarchical modelling (BHM) to evaluate the totality of evidence for an effect of the intervention over 36 months. The analysis includes 67 participants (39 active, 28 control) with change from baseline data after 36 months intervention. All outcome measures showed a statistically significant effect for the intervention: ADCOMS (P =0.045), GST (P <0.001), and BHM (P =0.008 based on 3 outcomes and P <0.001 including all primary and secondary quantitative clinical outcomes). Fortasyn Connect was associated with significantly less clinical decline over 36 months, suggesting the long-lasting beneficial effects of the multinutrient in prodromal AD.

Keywords: Cognitive function; Fortasyn Connect; Souvenaid; nutrients.

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Conflict of interest statement

SBH is founder, owner and an employee of Pentara Corporation, and consults with dozens of companies in the Alzheimer’s space. She has received consulting fees through Pentara from Nutricia related to this work. HS reports grants from Kuopio University Hospital, Finland (EVO/VTR grant), and Academy of Finland grant 287490, during the conduct of the study, and personal fees from the Steering committee of the Evoke study conducted by Novo Nordisk, outside the submitted work. HS is the Lead medical PI of LipiDiDiet. AS reports a grant from the Academy of Finland (grant 287490), during the conduct of the study. PJV reports grants from the European Commission under the 7th framework program of the European Union (grant agreement number 211696), during the conduct of the study. AMJH and DSC are employees of Danone Nutricia Research. JNJ is a full time employee of Pentara Corporation, a company that consults with dozens of companies in the Alzheimer’s space, including Nutricia. SPD is a full time employee of Pentara Corporation, a company that consults with dozens of companies in the Alzheimer’s space, including Nutricia. KB served as a consultant at advisory boards for Acumen, ALZPath, BioArctic, Biogen, Eisai, Julius Clinical, Lilly, Novartis, Ono Pharma, Prothena, Roche Diagnostics, and Siemens Healthineers; has served at data monitoring committees for Julius Clinical and Novartis; has given lectures, produced educational materials and participated in educational programs for Biogen, Eisai and Roche Diagnostics; and is a co-founder of Brain Biomarker Solutions in Gothenburg AB (BBS), which is a part of the GU Ventures Incubator Program, outside the work presented in this paper. MK reports grants from the EU Joint Program BMBF 01ED1509 MIND-AD and the EU Joint Program BMBF 01ED2003 EU-FINGERS, during the conduct of the study; advisory boards for Combinostics, Biogen, and BioArtic; speaker for Biogen, Roche, Nestle, and Nutricia, and reports other grant support from CIMED, Stiftelse Stockholms Sjukhem, ALF. TH reports grants from the European Commission grant agreement number 211696, EU Joint Program BMBF 01ED1509 (MIND-AD), EU Joint Program BMBF 01ED2003 (EU-FINGERS), and Danone Nutricia Research to LipiDiDiet Consortium (month 25-96), during the conduct of the study. TH is the coördinator of LipiDiDiet.

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