Scheltens Nienke M E, Kuyper Ingrid S, Boellaard Ronald, Barkhof Frederik, Teunissen Charlotte E, Broersen Laus M, Lansbergen Marieke M, van der Flier Wiesje M, van Berckel Bart N M, Scheltens Philip
Alzheimer Center and Department of Neurology, Neuroscience Campus Amsterdam, VU University Medical Center, Amsterdam, The Netherlands.
Department of Radiology and Nuclear Medicine, Neuroscience Campus Amsterdam, VU University Medical Center, Amsterdam, The Netherlands.
Alzheimers Dement (N Y). 2016 Sep 1;2(4):233-240. doi: 10.1016/j.trci.2016.07.004. eCollection 2016 Nov.
Alzheimer's disease is associated with early synaptic loss. Specific nutrients are known to be rate limiting for synapse formation. Studies have shown that administering specific nutrients may improve memory function, possibly by increasing synapse formation. This Dutch study explores the Effect of a specific Nutritional Intervention on cerebral Glucose Metabolism in early Alzheimer's disease (NL-ENIGMA, Dutch Trial Register NTR4718, http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4718). The NL-ENIGMA study is designed to test whether the specific multinutrient combination Fortasyn Connect present in the medical food Souvenaid influences cerebral glucose metabolism as a marker for improved synapse function.
This study is a double-blind, randomized controlled parallel-group single-center trial. Forty drug-naive patients with mild cognitive impairment or mild dementia with evidence of amyloid deposition are 1:1 randomized to receive either the multinutrient combination or placebo once daily. Main exploratory outcome parameters include absolute quantitative positron emission tomography with F-fluorodeoxyglucose (including arterial sampling) and standard uptake value ratios normalized for the cerebellum or pons after 24 weeks.
We expect the NL-ENIGMA study to provide further insight in the potential of this multinutrient combination to improve synapse function.
阿尔茨海默病与早期突触丧失有关。已知特定营养素是突触形成的限速因素。研究表明，给予特定营养素可能改善记忆功能，可能是通过增加突触形成来实现。这项荷兰研究探讨了特定营养干预对早期阿尔茨海默病患者脑葡萄糖代谢的影响（荷兰-ENIGMA，荷兰试验注册编号NTR4718，http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4718）。荷兰-ENIGMA研究旨在测试医学食品Souvenaid中含有的特定多种营养素组合Fortasyn Connect是否会影响脑葡萄糖代谢，以此作为突触功能改善的标志物。
本研究为双盲、随机对照平行组单中心试验。40例未服用过药物、有轻度认知障碍或轻度痴呆且有淀粉样蛋白沉积证据的患者按1:1随机分组，每天接受一次多种营养素组合或安慰剂治疗。主要探索性结局参数包括24周后使用F-氟脱氧葡萄糖进行的绝对定量正电子发射断层扫描（包括动脉采样）以及针对小脑或脑桥标准化的标准摄取值比率。
我们期望荷兰-ENIGMA研究能进一步深入了解这种多种营养素组合改善突触功能的潜力。
