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

Soininen H, Solomon A, Visser P, Hendrix S, Blennow K, Kivipelto M, Hartmann T (2020) Alzheimer's & Dementia (2020)  DOI: 10.1002/alz.12172 

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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%; 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.

 

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For the related news articles on this, and the previous report from this trial, please see:


The special nutritional formulation used in this trial has a long research history.  Its original development was theory-driven - as it includes all of the different vitamins, minerals, and essential fatty acids that are known to be needed to build or repair cell membranes.

Before its adoption for the EU LipidiDiet programme, this combination of micronutrients had already shown some promise for slowing age-related cognitive decline in earlier small clinical trials involving patients with early-stage dementia, after significant benefits for memory and cognition were first established in animal studies modelling Alzheimer's disease.

For details of previous studies using this broad-spectrum nutrient formulation, see: