24-month intervention with a specific multinutrient in people with prodromal Alzheimer's disease (LipiDiDiet): a randomised, double-blind, controlled trial

The Lancet Neurology - Tập 16 Số 12 - Trang 965-975 - 2017
Hilkka Soininen1,2, Alina Solomon3,4,1, Pieter Jelle Visser5,6, Suzanne Hendrix7, Kaj Blennow8,9, Miia Kivipelto3,4,1, Tobias Hartmann10, Ilona Hallikainen, Merja Hallikainen, Seppo Helisalmi, Tarja Lappalainen, Yawu Liu, Teemu Paajanen, Lars‐Olof Wahlund, Yvonne Freund‐Levi, Niels Andreasen, Göran Hagman, Stina Lindblom, Klaus Faßbender, Markus J. Riemenschneider, Marcus O.W. Grimm, Aline Klees-Rollmann, Maxine Luley, Epameinondas Lyros, Robert Schomburg, Jennifer Kennel, Daniela Ramelli, Lutz Frölich, Lucrezia Hausner, Christoph Laske, Thomas Leyhe, Christian Mychajliw, Niklas Koehler, Stephan Schiekofer, Hans H. Klünemann, Johannes Schröder, Dieter Lütjohann, Philip Scheltens, Ineke van Rossum, Nienke M.E. Scheltens, Daniela Bertens, Mara ten Kate, Frederik Barkhof, J.M.L. Henselmans, Gerwin Roks, Anneke M.J. van Hees, Noel Ellison
1Department of Neurology, Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland
2Neurocenter, Department of Neurology, Kuopio University Hospital, Kuopio, Finland
3Clinical Trials Unit, Department of Geriatric Medicine, Karolinska University Hospital, Huddinge, Sweden
4Department of Clinical Geriatrics, Department of Neurobiology, Care Sciences and Society, Karolinska Institute, Huddinge, Sweden
5Department of Neurology, Alzheimer Center, Amsterdam Neuroscience, VU University Medical Center, Amsterdam, Netherlands
6Department of Psychiatry and Neuropsychology, Alzheimer Center Limburg, University of Maastricht, Maastricht, Netherlands
7Pentara Corporation, Salt Lake City, UT, USA
8Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden
9Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, The Sahlgrenska Academy at University of Gothenburg, Mölndal, Sweden
10German Institute for Dementia Prevention (DIDP), Medical Faculty, and Department of Experimental Neurology, Saarland University, Homburg, Germany

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Aisen, 2011, Report of the task force on designing clinical trials in early (predementia) AD, Neurology, 76, 280, 10.1212/WNL.0b013e318207b1b9

Scheltens, 2016, Alzheimer's disease, Lancet, 388, 505, 10.1016/S0140-6736(15)01124-1

Dubois, 2007, Research criteria for the diagnosis of Alzheimer's disease: revising the NINCDS-ADRDA criteria, Lancet Neurol, 6, 734, 10.1016/S1474-4422(07)70178-3

Dubois, 2014, Advancing research diagnostic criteria for Alzheimer's disease: the IWG-2 criteria, Lancet Neurol, 13, 614, 10.1016/S1474-4422(14)70090-0

Albert, 2011, The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease, Alzheimers Dement, 7, 270, 10.1016/j.jalz.2011.03.008

Ngandu, 2015, A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial, Lancet, 385, 2255, 10.1016/S0140-6736(15)60461-5

Andrieu, 2017, Effect of long-term omega 3 polyunsaturated fatty acid supplementation with or without multidomain intervention on cognitive function in elderly adults with memory complaints (MAPT): a randomised, placebo-controlled trial, Lancet Neurol, 16, 377, 10.1016/S1474-4422(17)30040-6

Scarmeas, 2009, Mediterranean diet and mild cognitive impairment, Arch Neurol, 66, 216

Smith, 2010, Homocysteine-lowering by B vitamins slows the rate of accelerated brain atrophy in mild cognitive impairment: a randomized controlled trial, PLoS One, 5, e12244, 10.1371/journal.pone.0012244

van Wijk, 2014, Targeting synaptic dysfunction in Alzheimer's disease by administering a specific nutrient combination, J Alzheimers Dis, 38, 459, 10.3233/JAD-130998

de Wilde, 2003, Dietary fatty acids alter blood pressure, behavior and brain membrane composition of hypertensive rats, Brain Res, 988, 9, 10.1016/S0006-8993(03)03320-1

Wurtman, 2006, Synaptic proteins and phospholipids are increased in gerbil brain by administering uridine plus docosahexaenoic acid orally, Brain Res, 1088, 83, 10.1016/j.brainres.2006.03.019

de Wilde, 2011, Neuroprotective effects of a specific multi-nutrient intervention against Abeta42-induced toxicity in rats, J Alzheimers Dis, 27, 327, 10.3233/JAD-2011-110635

Savelkoul, 2012, A specific multi-nutrient formulation enhances M1 muscarinic acetylcholine receptor responses in vitro, J Neurochem, 120, 631, 10.1111/j.1471-4159.2011.07616.x

Broersen, 2013, A specific multi-nutrient diet reduces alzheimer-like pathology in young adult AbetaPPswe/PS1dE9 mice, J Alzheimers Dis, 33, 177, 10.3233/JAD-2012-112039

Koivisto, 2014, Special lipid-based diets alleviate cognitive deficits in the APPswe/PS1dE9 transgenic mouse model of Alzheimer's disease independent of brain amyloid deposition, J Nutr Biochem, 25, 157, 10.1016/j.jnutbio.2013.09.015

Zerbi, 2014, Multinutrient diets improve cerebral perfusion and neuroprotection in a murine model of Alzheimer's disease, Neurobiol Aging, 35, 600, 10.1016/j.neurobiolaging.2013.09.038

Holguin, 2008, Dietary uridine enhances the improvement in learning and memory produced by administering DHA to gerbils, FASEB J, 22, 3938, 10.1096/fj.08-112425

Jansen, 2013, Effects of specific multi-nutrient enriched diets on cerebral metabolism, cognition and neuropathology in AbetaPPswe-PS1dE9 mice, PLoS One, 8, e75393, 10.1371/journal.pone.0075393

Cansev, 2015, A specific multi-nutrient enriched diet enhances hippocampal cholinergic transmission in aged rats, Neurobiol Aging, 36, 344, 10.1016/j.neurobiolaging.2014.07.021

Janickova, 2015, Lipid-based diets improve muscarinic neurotransmission in the hippocampus of transgenic APPswe/PS1dE9 Mice, Curr Alzheimer Res, 12, 923, 10.2174/1567205012666151027130350

de Wilde, 2017, Lower brain and blood nutrient status in Alzheimer's disease: results from meta-analyses, Alzheimers Dement, 3, 416, 10.1016/j.trci.2017.06.002

Scheltens, 2010, Efficacy of a medical food in mild Alzheimer's disease: a randomized, controlled trial, Alzheimers Dement, 6, 1, 10.1016/j.jalz.2009.10.003

Scheltens, 2012, Efficacy of Souvenaid in mild Alzheimer's disease: results from a randomized, controlled trial, J Alzheimers Dis, 31, 225, 10.3233/JAD-2012-121189

de Waal, 2014, The effect of Souvenaid on functional brain network organisation in patients with mild Alzheimer's disease: a randomised controlled study, PLoS One, 9, e86558, 10.1371/journal.pone.0086558

Shah, 2013, The S-Connect study: results from a randomized, controlled trial of Souvenaid in mild-to-moderate Alzheimer's disease, Alzheimers Res Ther, 5, 59, 10.1186/alzrt224

Olde Rikkert, 2015, Tolerability and safety of Souvenaid in patients with mild Alzheimer's disease: results of multi-center, 24-week, open-label extension study, J Alzheimers Dis, 44, 471, 10.3233/JAD-141305

Cummings, 2017, Effect size analyses of Souvenaid in patients with Alzheimer's disease, J Alzheimers Dis, 55, 1131, 10.3233/JAD-160745

Harrison, 2007, A neuropsychological test battery for use in Alzheimer disease clinical trials, Arch Neurol, 64, 1323, 10.1001/archneur.64.9.1323

Hamel, 2015, The trajectory of cognitive decline in the pre-dementia phase in memory clinic visitors: findings from the 4C-MCI study, Psychol Med, 45, 1509, 10.1017/S0033291714002645

Ellis, 2014, Rates of diagnostic transition and cognitive change at 18-month follow-up among 1,112 participants in the Australian Imaging, Biomarkers and Lifestyle Flagship Study of Ageing (AIBL), Int Psychogeriatr, 26, 543, 10.1017/S1041610213001956

Kamphuis, 2011, Efficacy of a medical food on cognition in Alzheimer's disease: results from secondary analyses of a randomized, controlled trial, J Nutr Health Aging, 15, 720, 10.1007/s12603-011-0105-6

Vellas, 2015, Endpoints for pre-dementia AD trials: a report from the EU/US/CTAD Task Force, J Prev Alzheimers Dis, 2, 128

Vellas, 2008, Endpoints for trials in Alzheimer's disease: a European task force consensus, Lancet Neurol, 7, 436, 10.1016/S1474-4422(08)70087-5

Vos, 2015, Prevalence and prognosis of Alzheimer's disease at the mild cognitive impairment stage, Brain, 138, 1327, 10.1093/brain/awv029

Coric, 2015, Targeting prodromal Alzheimer disease with avagacestat: a randomized clinical trial, JAMA Neurol, 72, 1324, 10.1001/jamaneurol.2015.0607