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| 30.10.2017, E.U. funded research consortium “LipiDiDiet” finds a way to impact Alzheimer’s Disease before it’s too late: data published in The Lancet Neurology
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30 October 2017, Full results from the European LipiDiDiet clinical trial were published online today in The Lancet Neurology1. The trial showed that in people with prodromal Alzheimer’s (the pre-dementia stage of this disease), consumption of a once-daily medical nutrition drink, whilst not improving a specific neuropsychological test battery (NTB)*, did result in a significant stabilisation of everyday cognitive and functional performance, as well as reduced brain shrinkage. The drink contains “Fortasyn Connect”, a specific combination of essential fatty acids, vitamins and other nutrients**. The pioneering clinical trial is part of a large European Union funded project and involved 311 patients across 11 sites in four countries (Finland, Germany, the Netherlands and Sweden). The trial involved patients with prodromal Alzheimer’s (often referred to as Mild Cognitive Impairment or MCI). Patients were randomised to receive either the nutritional intervention or an iso-caloric control drink for 24 months. The study’s primary endpoint, impact on NTB, was not met. The decline in the NTB of the control group was less than anticipated rendering this analysis statistically underpowered. However, key secondary endpoints showed significant advantages for nutrient-treated patients with 45% less worsening in the Clinical Dementia Rating-Sum of Box (CDR-SB). This measure is especially important because it tracks the patient’s disease progression based on performance in managing everyday life, such as handling household emergencies, handling financial transactions or forgetting a major event. Furthermore, there was less brain atrophy in the active group, with 26% difference for the hippocampus and 16% for the ventricular volume. Progressive brain degeneration is typical for Alzheimer’s, with hippocampal damage being responsible for many of the associated memory deficits. Over the 24-month period the incidence of any adverse events were similar between the active and control groups. Professor Hilkka Soininen, Professor in Neurology MD, PhD from the University of Eastern Finland, who headed the clinical trial as part of the LipiDiDiet project, said: "Today's results, published in The Lancet Neurology, are extremely valuable as they bring us closer to understanding the impact of nutritional interventions on prodromal Alzheimer’s, which we are now better at diagnosing but unable to treat due to a lack of approved pharmaceutical options. The LipiDiDiet study illustrates that this nutritional intervention can help to conserve brain tissue and also memory and patients' ability to perform everyday tasks – possibly the most troubling aspects of the disease.” The LipiDiDiet trial is now the third clinical trial on this nutritional intervention to show favourable effects on memory performance. The two previous clinical trials involved patients with mild Alzheimer’s dementia and reported that daily intake of the nutritional intervention improved memory performance and increased measures of synaptic and functional connectivity in the brain. Professor Tobias Hartmann, the project’s coordinator, said: “While this nutritional intervention is not a cure for Alzheimer’s, it effectively shows that the earlier in the disease process we intervene, the greater the advantage for the patient. Importantly, reduced atrophy in the patient’s brain shows that the benefit extends beyond symptomatic effects, something never before achieved." Fortasyn Connect is the combination of active nutrients in a once daily 125ml medical nutrition drink (called Souvenaid). The multi-nutrient combination is supported by almost 20 years of extensive research, based on initial preclinical research by Professor Kiliaan (Radboud University, the Netherlands), by the LipiDiDiet and LipiDiDiet projects, coordinated by Professor Hartmann (Saarland University, Germany) and funded by the European Union FP5 and FP7 research programs, and by Professor Wurtman (formerly at the Massachusetts Institute of Technology, U.S.A) supported principally by the National Institutes of Health. 47 million people have Alzheimer’s or a related dementia for which there is currently no cure.2 Alzheimer’s has a long pre-dementia (or predementia) phase with first signs of cognitive decline appearing several years before the onset of dementia. Many patients with the early symptoms of the disease can now be diagnosed in advance of dementia fully manifesting. The number of people living with Alzheimer’s dementia is expected to double every 20 years, reaching 74.7 million in 2030 and 131.5 million in 2050.
* The neuropsychological test battery (NTB) is a composite of different tests. In this case it included learning, recalling and recognising 10 high-frequency, high-imagery nouns, to recollect as many words that belong to the animals category and a letter digit substitution test. ** Fortasyn Connect contains a combination of nutrients including omega-3 fatty acids, choline, uridine monophosphate, phospholipids, antioxidants and B vitamins. It is a Food for Special Medical Purpose (FSMP), clinically proven for the dietary management of early Alzheimer’s disease.
For further media information or to be put in touch with Professor Soininen or Professor Hartmann, please contact: Jake Davis, +44 7843 448 252, jake.davis(at)havas.com or Imaan Petra, +44 7515 391 844, imaan.petra(at)havas.com
References
30 October 2017, Full results from the European LipiDiDiet clinical trial were published online today in The Lancet Neurology1. The trial showed that in people with prodromal Alzheimer’s (the pre-dementia stage of this disease), consumption of a once-daily medical nutrition drink, whilst not improving a specific neuropsychological test battery (NTB)*, did result in a significant stabilisation of everyday cognitive and functional performance, as well as reduced brain shrinkage. The drink contains “Fortasyn Connect”, a specific combination of essential fatty acids, vitamins and other nutrients**. The pioneering clinical trial is part of a large European Union funded project and involved 311 patients across 11 sites in four countries (Finland, Germany, the Netherlands and Sweden). The trial involved patients with prodromal Alzheimer’s (often referred to as Mild Cognitive Impairment or MCI). Patients were randomised to receive either the nutritional intervention or an iso-caloric control drink for 24 months. The study’s primary endpoint, impact on NTB, was not met. The decline in the NTB of the control group was less than anticipated rendering this analysis statistically underpowered. However, key secondary endpoints showed significant advantages for nutrient-treated patients with 45% less worsening in the Clinical Dementia Rating-Sum of Box (CDR-SB). This measure is especially important because it tracks the patient’s disease progression based on performance in managing everyday life, such as handling household emergencies, handling financial transactions or forgetting a major event. Furthermore, there was less brain atrophy in the active group, with 26% difference for the hippocampus and 16% for the ventricular volume. Progressive brain degeneration is typical for Alzheimer’s, with hippocampal damage being responsible for many of the associated memory deficits. Over the 24-month period the incidence of any adverse events were similar between the active and control groups. Professor Hilkka Soininen, Professor in Neurology MD, PhD from the University of Eastern Finland, who headed the clinical trial as part of the LipiDiDiet project, said: "Today's results, published in The Lancet Neurology, are extremely valuable as they bring us closer to understanding the impact of nutritional interventions on prodromal Alzheimer’s, which we are now better at diagnosing but unable to treat due to a lack of approved pharmaceutical options. The LipiDiDiet study illustrates that this nutritional intervention can help to conserve brain tissue and also memory and patients' ability to perform everyday tasks – possibly the most troubling aspects of the disease.” The LipiDiDiet trial is now the third clinical trial on this nutritional intervention to show favourable effects on memory performance. The two previous clinical trials involved patients with mild Alzheimer’s dementia and reported that daily intake of the nutritional intervention improved memory performance and increased measures of synaptic and functional connectivity in the brain. Professor Tobias Hartmann, the project’s coordinator, said: “While this nutritional intervention is not a cure for Alzheimer’s, it effectively shows that the earlier in the disease process we intervene, the greater the advantage for the patient. Importantly, reduced atrophy in the patient’s brain shows that the benefit extends beyond symptomatic effects, something never before achieved." Fortasyn Connect is the combination of active nutrients in a once daily 125ml medical nutrition drink (called Souvenaid). The multi-nutrient combination is supported by almost 20 years of extensive research, based on initial preclinical research by Professor Kiliaan (Radboud University, the Netherlands), by the LipiDiDiet and LipiDiDiet projects, coordinated by Professor Hartmann (Saarland University, Germany) and funded by the European Union FP5 and FP7 research programs, and by Professor Wurtman (formerly at the Massachusetts Institute of Technology, U.S.A) supported principally by the National Institutes of Health. 47 million people have Alzheimer’s or a related dementia for which there is currently no cure.2 Alzheimer’s has a long pre-dementia (or predementia) phase with first signs of cognitive decline appearing several years before the onset of dementia. Many patients with the early symptoms of the disease can now be diagnosed in advance of dementia fully manifesting. The number of people living with Alzheimer’s dementia is expected to double every 20 years, reaching 74.7 million in 2030 and 131.5 million in 2050.
* The neuropsychological test battery (NTB) is a composite of different tests. In this case it included learning, recalling and recognising 10 high-frequency, high-imagery nouns, to recollect as many words that belong to the animals category and a letter digit substitution test. ** Fortasyn Connect contains a combination of nutrients including omega-3 fatty acids, choline, uridine monophosphate, phospholipids, antioxidants and B vitamins. It is a Food for Special Medical Purpose (FSMP), clinically proven for the dietary management of early Alzheimer’s disease.
For further media information or to be put in touch with Professor Soininen or Professor Hartmann, please contact: Jake Davis, +44 7843 448 252, jake.davis(at)havas.com or Imaan Petra, +44 7515 391 844, imaan.petra(at)havas.com
References
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| 10.03.2016, Lipid-based diets effectively combat Alzheimer's disease in mouse model
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A Clinical Trial investigating the effects of Fortasyn Connect (Souvenaid) in Prodromal Alzheimer’s Disease: Results of the LipiDiDiet study H. Soininen, P.J. Visser, M. Kivipelto, T. Hartmann for the LipiDiDiet study group (2016), presentation held at 14th International Athens/Springfield Symposium on Advances in Alzheimer Therapy, March 10, 2016 |
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| 01.05.2015, Vascular effects of oxysterols and oxyphytosterols in apoE -/- mice.
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ATHEROSCLEROSIS, 2015 May; 240(1):73-9. Oliver Weingärtner, Constanze Husche, Hans-Frieder Schött, Timo Speer, Michael Böhm, Charlotte M. Miller, Florence O. McCarthy, Jogchum Plat, Dieter Lütjohann, and Ulrich Laufs In this study, we investigated the effects of oxidized cholesterol and oxidized sitosterol in mice. The major novel finding in this study is that the i.p. application of plant sterols or their oxidation products result in elevated plasma levels and increases sterol concentrations in the arterial wall. Interestingly, application of non-oxidized cholesterol or sitosterol increases their respective plasma concentrations but does not give rise to increased oxysterol or oxyphytosterol concentrations suggesting that endogenous oxidation does not play a major role in this context. Finally, only the elevation of 7β-OH-sitosterol resulted in increased ROS production in the arterial wall, but this did not affect endothelial cell quantification, endothelial cell migration, endothelial function, and early atherosclerotic lesion development. |
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| 22.04.2015, Long-term treatment with Ginkgo biloba extract EGb 761 improves symptoms and pathology in a transgenic mouse model of Alzheimer's disease.
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Brain Behav Immun. 2015 May;46:121-31. Liu X, Hao W, Qin Y, Decker Y, Wang X, Burkart M, Schötz K, Menger MD, Fassbender K, Liu Y. Inflammation in the brain is the main hallmark of Alzheimer’s disease (AD) and contributes to the disease pathogenesis. The extract from leaves of Ginkgo trees has been mixed with docosahexaenoic acid (DHA) an important omega-3 fatty acid and sold as a nutritional product for the prevention of AD. With this publication the LipiDiDiet researchers show how Ginkgo biloba extract reduces the inflammation in the AD brain. |
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| 01.04.2015, Leisure-time physical activity from mid- to late life, body mass index, and risk of dementia
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Alzheimers Dement. 2015 Apr;11(4):434-443 Tolppanen AM, Solomon A, Kulmala J, Kareholt I, Ngandu T, Rusanen M, Laatikainen T, Soininen H, Kivipelto M. The study investigated the associations between leisure-time physical activity from mid- to late life, the risk of dementia, and the role of body mass index, sex and APOE during 28-year follow-up. Moderate and low levels of midlife physical activity were associated with higher risk of dementia in comparison with the most active category. The benefits were more pronounced among men, overweight individuals, and APOE ε4 non-carriers. Maintaining high levels of physical activity or increasing physical activity after midlife was associated with lower dementia risk. |
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