Abstract
| Original language | English |
|---|---|
| Pages (from-to) | 29-40 |
| Number of pages | 12 |
| Journal | Alzheimer's and Dementia |
| Volume | 17 |
| Issue number | 1 |
| Early online date | 2020 |
| DOIs | |
| Publication status | Published - Jan 2021 |
Keywords
- Alzheimer's disease
- atrophy
- cognition
- dietary intervention
- function
- hippocampus
- mild cognitive impairment
- nutrition
- omega 3
- prodromal
- randomized controlled clinical trial
- therapy
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In: Alzheimer's and Dementia, Vol. 17, No. 1, 01.2021, p. 29-40.
Research output: Contribution to journal › Article › Academic › peer-review
TY - JOUR
T1 - 36-month LipiDiDiet multinutrient clinical trial in prodromal Alzheimer's disease
AU - Soininen, Hilkka
AU - Solomon, Alina
AU - Visser, Pieter Jelle
AU - Hendrix, Suzanne B.
AU - Blennow, Kaj
AU - Kivipelto, Miia
AU - Hartmann, Tobias
N1 - Funding Information: The research leading to these results was mainly funded by the European Commission under the seventh framework programme of the European Union (grant agreement no. 211696); Danone Nutricia Research funded part of the 36‐months study; additional funding for this study was provided by the EU Joint Programme– Neurodegenerative Disease Research (JPND) MIND‐AD grant to MK, HS, TH; EU Joint Programme– Neurodegenerative Disease Research (JPND) EURO‐FINGERS grant to MK, TH; Kuopio University Hospital, Finland (EVO/VTR grant; HS); Alzheimerfonden Sweden; Swedish Research Council; Stockholm City Council (ALF grant); Center for Innovative Medicine (CIMED) at Karolinska Institute, Sweden; Stiftelsen Stockholms sjukhem, Sweden; European Research Council (grant 804371); and Academy of Finland grants (317465, 287490). The European Commission had no role in study design, data collection, analysis and interpretation, writing of the report, or the decision to submit for publication. Danone Nutricia Research had no role in study design, data collection, and the decision to submit for publication, and as part of the LipiDiDiet consortium was involved in 36‐month data analysis and writing of the current report. All decisions taken on design, analysis, interpretation, and decision to submit for publication were made by the LipiDiDiet Trial Steering Committee, excluding Danone Nutricia Research. HS, AS, PJV, SBH, KB, MK, and TH had full access to all the data in the study. The corresponding author had final responsibility for the decision to submit for publication. We sincerely thank all participants enrolled in the study and their families. We thank Nico Rozendaal, Jose de Bont, Anja Kerksiek, and all investigators and on‐site study staff for their efforts in the conduct of the field work and all preclinical researchers for their design contributions. A full list of collaborators is provided in the supporting information. Editorial support and language correction were provided by Tim Kelly (Medi‐Kelsey Limited), funded by Danone Nutricia Research. Funding Information: The research leading to these results was mainly funded by the European Commission under the seventh framework programme of the European Union (grant agreement no. 211696); Danone Nutricia Research funded part of the 36-months study; additional funding for this study was provided by the EU Joint Programme? Neurodegenerative Disease Research (JPND) MIND-AD grant to MK, HS, TH; EU Joint Programme? Neurodegenerative Disease Research (JPND) EURO-FINGERS grant to MK, TH; Kuopio University Hospital, Finland (EVO/VTR grant; HS); Alzheimerfonden Sweden; Swedish Research Council; Stockholm City Council (ALF grant); Center for Innovative Medicine (CIMED) at Karolinska Institute, Sweden; Stiftelsen Stockholms sjukhem, Sweden; European Research Council (grant 804371); and Academy of Finland grants (317465, 287490). The European Commission had no role in study design, data collection, analysis and interpretation, writing of the report, or the decision to submit for publication. Danone Nutricia Research had no role in study design, data collection, and the decision to submit for publication, and as part of the LipiDiDiet consortium was involved in 36-month data analysis and writing of the current report. All decisions taken on design, analysis, interpretation, and decision to submit for publication were made by the LipiDiDiet Trial Steering Committee, excluding Danone Nutricia Research. HS, AS, PJV, SBH, KB, MK, and TH had full access to all the data in the study. The corresponding author had final responsibility for the decision to submit for publication. We sincerely thank all participants enrolled in the study and their families. We thank Nico Rozendaal, Jose de Bont, Anja Kerksiek, and all investigators and on-site study staff for their efforts in the conduct of the field work and all preclinical researchers for their design contributions. A full list of collaborators is provided in the supporting information. Editorial support and language correction were provided by Tim Kelly (Medi-Kelsey Limited), funded by Danone Nutricia Research. Publisher Copyright: © 2020 The Authors. Alzheimer's & Dementia published by Wiley Periodicals, Inc. on behalf of Alzheimer's Association Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/1
Y1 - 2021/1
N2 - Introduction: The LipiDiDiet trial investigates the effects of the specific multinutrient combination Fortasyn Connect on cognition and related measures in prodromal Alzheimer's disease (AD). Based on previous results we hypothesized that benefits increase with long-term intervention. Methods: In this randomized, double-blind, placebo-controlled trial, 311 people with prodromal AD were recruited using the International Working Group-1 criteria and assigned to active product (125 mL once-a-day drink) or an isocaloric, same tasting, placebo control drink. Main outcome was change in cognition (Neuropsychological Test Battery [NTB] 5-item composite). Analyses were by modified intention-to-treat, excluding (ie, censoring) data collected after the start of open-label active product and/or AD medication. Results: Of the 382 assessed for eligibility, 311 were randomized, of those 162 participants completed the 36-month study, including 81 with 36-month data eligible for efficacy analysis. Over 36 months, significant reductions in decline were observed for the NTB 5-item composite (−60%; between-group difference 0.212 [95% confidence interval: 0.044 to 0.380]; P = 0.014), Clinical Dementia Rating-Sum of Boxes (−45%; P = 0.014), memory (−76%; P = 0.008), and brain atrophy measures; small to medium Cohen's d effect size (0.25–0.31) similar to established clinically relevant AD treatment. Discussion: This multinutrient intervention slowed decline on clinical and other measures related to cognition, function, brain atrophy, and disease progression. These results indicate that intervention benefits increased with long-term use.
AB - Introduction: The LipiDiDiet trial investigates the effects of the specific multinutrient combination Fortasyn Connect on cognition and related measures in prodromal Alzheimer's disease (AD). Based on previous results we hypothesized that benefits increase with long-term intervention. Methods: In this randomized, double-blind, placebo-controlled trial, 311 people with prodromal AD were recruited using the International Working Group-1 criteria and assigned to active product (125 mL once-a-day drink) or an isocaloric, same tasting, placebo control drink. Main outcome was change in cognition (Neuropsychological Test Battery [NTB] 5-item composite). Analyses were by modified intention-to-treat, excluding (ie, censoring) data collected after the start of open-label active product and/or AD medication. Results: Of the 382 assessed for eligibility, 311 were randomized, of those 162 participants completed the 36-month study, including 81 with 36-month data eligible for efficacy analysis. Over 36 months, significant reductions in decline were observed for the NTB 5-item composite (−60%; between-group difference 0.212 [95% confidence interval: 0.044 to 0.380]; P = 0.014), Clinical Dementia Rating-Sum of Boxes (−45%; P = 0.014), memory (−76%; P = 0.008), and brain atrophy measures; small to medium Cohen's d effect size (0.25–0.31) similar to established clinically relevant AD treatment. Discussion: This multinutrient intervention slowed decline on clinical and other measures related to cognition, function, brain atrophy, and disease progression. These results indicate that intervention benefits increased with long-term use.
KW - Alzheimer's disease
KW - atrophy
KW - cognition
KW - dietary intervention
KW - function
KW - hippocampus
KW - mild cognitive impairment
KW - nutrition
KW - omega 3
KW - prodromal
KW - randomized controlled clinical trial
KW - therapy
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85090829659&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/32920957
U2 - https://doi.org/10.1002/alz.12172
DO - https://doi.org/10.1002/alz.12172
M3 - Article
C2 - 32920957
SN - 1552-5260
VL - 17
SP - 29
EP - 40
JO - Alzheimer's and Dementia
JF - Alzheimer's and Dementia
IS - 1
ER -