|A Clincial Trial Investigating the Effects of Souvenaid® in Prodromal Alzheimer's Disease: Progress and Baseline Characteristics of the Lipididiet Study|| |
|P.J. Visser1,2, H. Soininen3, M. Kivipelto3,4, Y. Freund-Levi5, P.J.G.H. Kamphuis6, R.L. Wieggers6, T. Hartmann7,8|
|1Department of Psychiatry and Neuropsychology, Alzheimer Center Limburg, University of Maastricht, Maastricht, 2Department of Neurology, Alzheimer Center, VU University Medical Center, Amsterdam, The Netherlands, 3Department of Neurology, University of Eastern Finland and Kuopio University Hospital, Kuopio, Finland, 4Karolinska Institutet Alzheimer Disease Research Center, Aging Research Center and Karolinska University Hospital, 5Department of NVS, Section of Clinical Geriatrics, Karolinska Institutet, Karolinska University Hospital, Huddinge, Sweden, 6Nutricia Advanced Medical Nutrition, Danone Research, Centre for Specialised Nutrition, Wageningen, The Netherlands, 7Deutsches Institut für DemenzPrävention (DIDP), Neurodegeneration and Neurobiology, 8Experimental Neurology, Homburg, Germany|
|Objectives: Souvenaid®, containing the specific nutrient combination Fortasyn™ Connect1, is designed to support synapse formation and function in patients with Alzheimer's disease (AD). Two randomised controlled trials (RCTs) have shown that Souvenaid improves memory performance in drug-naïve mild AD patients (MMSE 20-26 and MMSE≥20), indicating that Souvenaid may have positive effects in (very) early AD as well. The 'LipiDiDiet' study2 is one of the first RCTs in prodromal AD, investigating the effects of Souvenaid on cognition. |
Methods: The LipiDiDiet study is a 24-month, double-blind, parallel-group RCT investigating the effects of Souvenaid in 300 prodromal AD patients (criteria Dubois, 2007). Primary outcome measure is cognitive functioning as assessed by a Neuropsychological Test Battery. Baseline characteristics of the study population are analysed.
Results: So far, randomised patients with available data (n=213, 47.9% male) had a mean age of 71.8±6.9 y, MMSE total score 26.6±2.0, ADAS-cog score 19.7±7.8, CSF β-amyloid 1-42/1-40x10 ratio 1.89±0.71, CSF total tau 465.5±269.6 pg/ml, CSF phosphorylated tau 74.5±35.6 pg/ml and MTA score 1.64±1.00 (MRI evidence for medial temporal lobe atrophy).
Conclusions: Baseline characteristics of the study population included in the LipiDiDiet study so far conform to the criteria for the target population of prodromal AD, with evidence for underlying AD pathology. Characteristics of the total study population will be presented at the conference. First results of the study are expected in 2015.
1Souvenaid is a registered trademark of N.V. Nutricia. Fortasyn is a trademark of N.V. Nutricia.
2Funded by the EU FP7 project LipiDiDiet, Grant Agreement N°211696.
Dr. Pieter Jelle Visser, University of Maastricht , Maastricht , The Netherlands
Assigned in sessions:
06.03.2013, 11:00-13:00, Clinical, SYM05, SYMPOSIUM 05
NUTRITION BASED TREATMENTS
SUPPORTED BY AN UNRESTRICTED EDUCATIONAL GRANT BY NUTRICIA, Hall B