"Toplineresults of the first randomised clinical trial in the world to investigate the effects of a nutritional intervention in very early AD predementia  Topline results from the European LipiDiDiet clinical trial were presented today as part of a latebreaking presentation at the Advances in Alzheimers Therapy AAT congress. They showed that in people with very early AD predementia a oncedaily nutritional drink designated a food for special medical purposes can help to reduce brain shrinkage  particularly in the hippocampal brain area the part of the brain that helps store shortterm memories for longterm retrieval. And for those who start the intervention early and consumed it regularly it can help to conserve memory and the ability to think and perform everyday tasks. The drink contains Fortasyn Connect a specific combination of fatty acids vitamins and other nutrients. This is the first time a randomised doubleblind clinical trial has shown that a nutritional intervention can help to conserve the ability of patients with very early AD predementia to carry out everyday tasks such as paying bills or finding your way around as measured by the Clinical Dementia RatingSum of Boxes CDRSB  a combined measure for the ability to think and perform everyday tasks. This is important because those with very early AD predementia currently have no approved available pharmacological options. The study did not find a significant benefit in broad cognitive function the study primary endpoint. Cognitive decline over the study period was less than originally expected when it was designed ten years ago so differences found between the two groups were too small to be statistically significant. Project coordinator Professor Tobias Hartmann Saarland University Germany explained that this is the most likely reason the primary endpoint was not met. 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 Todays results are extremely valuable as they bring us closer to understanding the impact of nutritional interventions on very early AD predementia 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. We look forward to the results of subsequent analyses and the six year extension study which will provide further insights. The clinical trial headed by Professor Hilkka Soininen is part of a large EC project LipiDiDiet to explore the therapeutic and preventative impact of nutrition on neuronal and cognitive performance in ageing AD and vascular dementia. LipiDiDiet is funded by the seventh Framework Programme FP of the European Commission EC and coordinated by Professor Hartmann Saarland University in Germany. Fortasyn Connect was selected by a consortium of leading researchers from  European institutes for this month randomised controlled doubleblind multicentre study involving  patients  on the basis of its results in a previous EU project LipiDiet. Nearly  million people have Alzheimers or a related dementia for which there is currently no cure. This number is expected to double every  years reaching . million in  and . million in .   Study details   The trial was the first to investigate the impact of Fortasyn Connect on patients with very early AD predementia who were randomised to receive either Fortasyn Connect or an isocaloric control drink once daily. The primary outcome parameter was selected to assess the effect on cognitive function a broad measure of thinking during  months intake of Fortasyn Connect compared with a control product. This was a cognitive composite score consisting of the CERAD word immediate recall delayed recall and recognition category fluency and letter digit substitution test. Secondary outcome parameters were brain volumes total hippocampal wholebrain  ventricular volumes the Clinical Dementia Rating Sum of Boxes CDRSB Neuropsychological Test Battery composite scores episodic memory executive functionworking memory composite and a complete composite score consisting of  subtests progression to AD dementia blood and CSF biomarkers tolerance and safety. No significant difference was observed for the cognitive composite score. Predefined analyses showed significant differences between active and control study groups for hippocampal and wholebrain atrophy and favourable effects for CDR Sum of Boxes and episodic memory both were most pronounced in patients with high baseline cognition with regular intake. Analyses are ongoing for progression to AD dementia and blood and CSF biomarkers. Tobias Hartmann the projects coordinator said We have known for a while that diet can reduce the risk of developing dementia. Indeed certain nutrients have been found to have a neuroprotective effect on the brain. However translating this into an effective intervention hasnt been easy because single nutrients simply arent powerful enough to fight a disease like Alzheimers alone. Todays clinical trial results have shown that the key is combining certain nutrients in order to increase their effect. This is exciting because it shows that in the absence of effective drug options we really have found something that can help slow down some of the most distressing symptoms in very early AD predementia especially in those who started the intervention early. Indeed those patients who have lost the least cognitive function have the most to gain.   Notes to editors   About LipiDiDiet  LipiDiDiet is an innovative project whose remit is dementia prevention related research. The initiative benefits from funding provided by the th Framework Programme FP  of the European Commission and follows on from previous projects in the field of dementia. The projects predecessor LipiDiet was incorporated within the th EU research programme in . Since its establishment evidence has been accumulated to support the hypothesis that certain nutritional molecules are beneficial in reducing disease progression in Alzheimers. This stimulated further research which led to the birth of the LipiDiDiet project. For more information about the LipiDiDiet study click here http   About Fortasyn Connect  Souvenaid is a once a day ml drink containing Fortasyn Connect  a combination of nutrients including omega 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 Alzheimers disease. Souvenaid is backed by  years of extensive research based on initial preclinical research by Prof. Kiliaan Radboud University the Netherlands by the LipiDiet project coordinated by Prof. Hartmann Saarland University Germany and funded by the European Union FP research programme and by Prof. Wurtman formerly at the Massachusetts Institute of Technology U.S.A supported principally by the National Institutes of Health. LipiDiDiet Consortium members   Saarland University Germany  University of Eastern Finland  University of Szeged Hungary  Tel Aviv University Israel  Stichting Katholieke Universiteit  Radboud University Nijmegen Medical Center The Netherlands  University of Gothenburg Sweden  Nutricia Research The Netherlands  Karolinska Institutet Sweden  Academy of Sciences of the Czech Republic  Institute of Physiology  VU University Medical Center The Netherlands  University of Bonn Germany  European Research and Project Office GmbH Germany  Heidelberg University Hospital Germany  University Hospital of Tbingen Germany  Central Institute for Mental Health Germany  University Hospital Regensburg Germany For further information on the European LipiDiDiet study and consortium visit http   References  . A Clinical Trial investigating the effects of Fortasyn Connect Souvenaid in Prodromal Alzheimers Disease Results of the LipiDiDiet study H. Soininen P.J. Visser M. Kivipelto T. Hartmann for the LipiDiDiet study group  presentation held at th International AthensSpringfield Symposium on Advances in Alzheimer Therapy March   . The World Alzheimer Report  The Global Impact of Dementia. Alzheimers Disease International ADI. Accessed March  via http Background information for the media on the LipiDiDiet Project and Study   Introduction to the LipiDiDiet Project  LipiDiDiet is an innovative project which was set up in  to address the impact of nutritional lipids on neuronal and cognitive performance in aging Alzheimers disease AD and Vascular Dementia. Its remit is twofold  the clinical and epidemiological assessment of the value of nutritional support in people at risk of developing AD and to conduct basic research to better understand and improve the possible therapeutic and preventive effects of nutrition in AD and Vascular Dementia. The projects predecessor LipiDiet was incorporated within the th EU research programme in . During its years of activity preclinical and epidemiological evidence was accumulated to support the hypothesis that certain nutritional molecules could be beneficial in reducing disease progression in Alzheimers. This stimulated further research which led to the birth of the LipiDiDiet project. About the European LipiDiDiet Study   As part of the LipiDiDiet project the first randomised clinical trial to investigate the effects of a medical food Fortasyn Connect Souvenaid in patients with very early AD predementia has just been completed. The trial was funded by the seventh Framework Programme FP of the European Commission EC and run by an independent consortium of  research partners throughout Europe. Professor Hilkka Soininen Professor in Neurology MD PhD from the University of Eastern Finland headed the clinical trial as part of the LipiDiDiet project. The study coordinator is Tobias Hartmann Professor for Experimental Neurology at the Saarland University Homburg Germany. For more information on the LipiDiDiet research partners please visit http For more information on the European Commission funded research projects please visit httpcordis.europa.eu European LipiDiDiet Study Rationale   It is well known that diet has a significant impact on cognitive function and cognitive decline. However whilst clinical trial results on single nutrient based interventions have been largely disappointing  epidemiological studies indicate that dietary patterns e.g. Mediterranean or healthy Nordic Diet are more effective in maintaining cognitive function and risk reduction than single nutrients. Extensive preclinical investigation which took place as part the LipiDiDiet project indicated that the nutrient combination in Fortasyn Connect has effects on multiple biological pathways that contribute to an overall neuroprotective effect. In addition earlier randomised controlled trials RCTs with the product have shown an improved memory performance in drugnave mild AD patients along with a good safety profile. LipiDiDiet Consortium members   Saarland University  University of Eastern Finland  University of Szeged  Tel Aviv University  Stichting Katholieke Universiteit  Radboud University Nijmegen Medical Center  University of Gothenburg    Nutricia Research  Karolinska Institutet  Academy of Sciences of the Czech Republic  Institute of Physiology  VU University Medical Center  University of Bonn  European Research and Project Office GmbH  Heidelberg University Hospital  University Hospital of Tuebingen  Central Institute for Mental Health  University Hospital Regensburg For further information on the European LipiDiDiet study and consortium visit http  SOURCE LipiDiDiet Consortium"