36‐month LipiDiDiet multinutrient clinical trial in prodromal Alzheimer's disease

Abstract

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%; This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

Research diagnostic criteria for Alzheimer’s disease: findings from the LipiDiDiet randomized controlled trial

“…The study was likely underpowered to detect these differences. Another explanation for these findings is that the changes, especially in NTB, were modest overall and lower than expected during the first 2 years of the LipiDiDiet trial [17] but closer to the expectation after 3 years [35]. Here, we observed that the changes were fairly small even among those with both abnormal Aβ and neuronal injury markers.…”

Concentrates of buttermilk and krill oil improve cognition in aged rats

“…Hence, there is justification for the use of supplements, either in the form of nutraceuticals or functional foods, to slow cognitive decline [2]. Some products are, indeed, available in the market and have been tested with equivocal results [30]. It must be underscored that there are several hurdles to overcome when fatty acids are tested in the cardiovascular or neurological arenas [31].…”

“…Fear conditioningConditioning and testing took place in a rodent observation cage using a shock generator (model LI100-26 Shocker, LETICA I.C., Madrid, Spain). The observation cage(30 x 37 x 25 cm) was placed in a sound-attenuating chamber. The side walls of the observation cage were constructed of stainless steel and the back walls and doors were constructed ofclear Plexiglass.…”

Redox lipidomics to better understand brain aging and function

“…The FINGER study is a randomised controlled trial with a multidomain intervention consisting of a 2 years intervention including diet, exercise, cognitive training and vascular risk monitoring, which demonstrated that this multidomain approach could improve or maintain cognitive functioning in at-risk elderly people [115]. Two years later, a 24-month multicentre trial in which prodromal Alzheimer's patients received a specific multinutrient showed that they had better results on the cognitive-functional measurements and less brain atrophy as assessed by magnetic resonance imaging (MRI) [116].…”