05 NOVEMBER 2020
Nutricia welcomes publication of LipiDiDiet clinical trial results of Souvenaid®
FOR HEALTHCARE PROFESSIONAL MEDIA ONLY
Press Release – Amsterdam, The Netherlands (November 5, 2020)
Nutricia welcomes publication in Alzheimer’s & Dementia of the 3 year LipiDiDiet clinical trial results of Souvenaid® (Fortasyn™Connect)* in prodromal Alzheimer’s disease
Nutricia, part of world-leading food, beverage and nutrition company Danone, today announced publication in the peer-reviewed journal of the Alzheimer’s Association – Alzheimer’s & Dementia – of the results after 36 months from the LipiDiDiet clinical trial, which addresses prodromal Alzheimer’s disease – the early stage of the disease, also referred to as mild cognitive impairment (MCI). This clinical trial has been evaluating the effects of a nutritional intervention (the drink Souvenaid®, containing a combination of nutrients called Fortasyn™Connect) on cognition and related measures in prodromal Alzheimer’s disease. After 36 months, the results of the trial showed this nutritional intervention slowed the decline on clinical and other measures related to cognition, function, brain atrophy, and disease progression. The results also indicate that the benefits of this intervention increased with long-term use.
“36‐month LipiDiDiet multinutrient clinical trial in prodromal Alzheimer's disease” was published online ahead of print in Alzheimer’s & Dementia. The LipiDiDiet clinical trial is being carried out by the LipiDiDiet Research Consortium made up of world leading researchers in neurology, led by Consortium Co-Ordinator and co-author Professor Dr. Tobias Hartmann, Department of Experimental Neurology, Saarland University, Germany: “Through research, we’re increasingly learning that early intervention is key, and in the LipiDiDiet study our consortium has been studying the potential long-term effects of certain nutrients on the brain of patients with prodromal Alzheimer’s Disease. The 36-month data clearly shows it’s possible to have a significant impact on the early stage of the disease. Importantly, we found the effect to be long-lasting and to improve the longer participants stayed in the trial.”
About the LipiDiDiet Research Consortium
The LipiDiDiet Research Consortium conducting the LipiDiDiet clinical trial was established to assess the impact of nutritional lipids on neuronal and cognitive performance in aging, Alzheimer’s disease and vascular dementia1. The LipiDiDiet clinical trial is the longest ever randomised, double-blind, controlled trial conducted in patients with mild cognitive impairment (MCI). 311 people were included in the study over a period of 36 months: one group was given the nutritional intervention Souvenaid® (Fortasyn™Connect) (a 125mL once-a-day drink), and a second group was given an isocaloric, same tasting, placebo control drink. The main objective of the study is to assess a change in cognition, using a number of neuropsychological tests called the NTB 5 item composite.
About the LipiDiDiet 3 Year Clinical Trial Results
Over 36 months (i.e. 3 years), significant reductions in decline were observed between the intervention and the control group for the NTB 5-item composite, CDR-SB (a set of tests assessing cognition & functional abilities), memory, and hippocampal, ventricular and whole brain atrophy (measured by MRI brain scans). Commenting on behalf of Nutricia, the developer of the nutritional intervention Souvenaid® (Fortasyn™Connect), Dr. Patrick Kamphuis, Senior Medical Affairs Director at Nutricia said, “These results show there is now an evidence-based nutritional option available to doctors to recommend for people with mild cognitive impairment, and furthermore the effects are both considerable in scale and long-lasting. We’re pleased to share this news with the Alzheimer’s community.”
About prodromal Alzheimer’s disease
Alzheimer’s disease (AD) is a progressive neurodegenerative disorder. Generally, the neuropathologic features of AD begin 15 to 20 years before obvious cognitive symptoms. The prodromal stage of AD is often referred to as mild cognitive impairment (MCI) due to AD. Individuals in the prodromal AD stage will exhibit obvious short-term memory deficits. Family members will often report that the individual at the prodromal AD stage will ask the same question over again as if they had not asked it before. They may misplace items more frequently and have more difficulty learning something new. Formal memory testing will typically reveal a reduced wordlist learning curve, lower-than-expected free delayed recall, false positive intrusions on word recall, and not clueing as well on word recognition testing. Often the individual will not recall the date correctly. Language skills, working memory, and sense of direction are generally intact, but there is usually some decline in problem solving and decision-making skills2.
About Souvenaid® (Fortasyn™Connect )*
Souvenaid® contains a combination of nutrients, called Fortasyn™Connect, designed to meet the specific nutritional needs of people in the early stages of Alzheimer’s disease. These include omega-3 polyunsaturated fatty acids (fish oil), uridine monophosphate and choline, together with phospholipids, B vitamins and other nutrients at levels difficult to achieve from normal dietary intake alone.
Since 1896, Nutricia has pioneered nutritional solutions that help people live longer, more joyful and healthier lives. Building on more than a century of research and innovation, Nutricia has harnessed the power of life-changing and life-saving nutrition to create a leading specialized nutrition portfolio that can change a health trajectory for life. With its nutritional solutions, Nutricia supports healthy growth and development during the first 1000 days and helps to address some of the world’s biggest health challenges; pre-term birth, faltering growth, food allergy, rare metabolic diseases, age-related conditions and chronic disease, such as frailty, cancer, stroke and early Alzheimer’s disease. As part of Danone, Nutricia embraces the company’s “One Planet. One Health” vision reflecting that the health of people and the health of the planet are interconnected and therefore seeks to protect and nourish both.
For more information visit www.nutricia.com