LONDON, October 31, 2017 /PRNewswire/ --
Full results from the European LipiDiDiet clinical trial were published online today in The Lancet Neurology(http://www.thelancet.com/journals/lancet/article/PIIS1474-4422(17)30332-0/fulltext?elsca1=tlxpr). 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 Boxes (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. 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.
LipiDiDiet is an innovative project whose remit is dementia prevention related research. The initiative benefits from funding provided by the 7th Framework Programme (FP7- 211696) of the European Commission, and follows on from previous projects in the field of dementia. The initiative is managed by an independent consortium of 19 research partners throughout Europe. The project's predecessor, LipiDiet, was incorporated within the 5th EU research programme in 2002.
Since its establishment, evidence has been accumulated to support the hypothesis that certain nutritional molecules are beneficial in reducing disease progression in Alzheimer's. This stimulated further research which led to the birth of the LipiDiDiet project.
LipiDiDiet Consortium Members
- Karolinska Institutet, Sweden
- University of Bonn, Germany
- European Research and Project Office GmbH, Germany
- Heidelberg University Hospital, Germany
- University Hospital of Tuebingen, Germany
- Saarland University, Germany
- University of Eastern Finland
- University of Szeged, Hungary
- Stichting Katholieke Universiteit - Radboud University Nijmegen Medical Center, the Netherlands
- University of Gothenburg, Sweden
- VU University Medical Center, The Netherlands
- Central Institute for Mental Health, Germany
- University Hospital Regensburg, Germany
- Academy of Sciences of the Czech Republic - Institute of Physiology, Czech republic
- Nutricia Research
- Tel Aviv University, Israel
For further information on the European LipiDiDiet study and consortium, visit: http://www.lipididiet.eu
1. Soininen H, Solomon A, Visser PJ, Hendrix SB, Blennow K, Kivipelto M, and Hartmann T on behalf of the LipiDiDiet clinical study group (2017). 24-month intervention with a specific multinutrient in patients with prodromal Alzheimer's disease (LipiDiDiet): a randomised, double-blind, controlled trial. The Lancet Neurology. Retrieved from http://www.thelancet.com/journals/lancet/article/PIIS1474-4422(17)30332-0/fulltext?elsca1=tlxpr.
2. The World Alzheimer Report 2015: 'The Global Impact of Dementia'. Alzheimer's Disease International (ADI). Accessed March 2016 via: http://www.worldalzreport2015.org
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SOURCE LipiDiDiet Consortium