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Combined metabolic activators improve cognitive functions in Alzheimer’s disease patients:a randomised,double-blinded,placebo-controlled phase-II trial

引用

Translational Neurodegeneration 2023年第1期12卷 849-871页

作者： Burak Yulug Ozlem Altay Xiangyu Li Lutfu Hanoglu Seyda Cankaya Simon Lam Halil Aziz Velioglu Hong Yang Ebru Coskun Ezgi Idil Rahim Nogaylar Ahmet Ozsimsek cemil bayram Ismail Bolat Sena Oner Ozlem Ozdemir Tozlu Mehmet Enes Arslan Ahmet Hacimuftuoglu Serkan Yildirim Muhammad Arif Saeed Shoaie Cheng Zhang Jens Nielsen Hasan Turkez Jan Borén Mathias Uhlén Adil Mardinoglu Department of Neurology and Neuroscience Faculty of MedicineAlanya Alaaddin Keykubat UniversityAntalyaTurkey Science for Life Laboratory KTH-Royal Institute of TechnologyStockholmSweden Department of Neurology Faculty of MedicineIstanbul Medipol UniversityIstanbulTurkey Centre for Host-Microbiome Interaction’s Faculty of DentistryOral and Craniofacial SciencesKing’s College LondonLondonUK Department of Women’s and Children’s Health Karolinska InstituteStockholmSweden Functional Imaging and Cognitive-Affective Neuroscience Lab Istanbul Medipol Univer-sityIstanbulTurkey Department of Medical Pharmacology Faculty of Medi-cineAtatürk UniversityErzurumTurkey Department of Pathology Veterinary FacultyAtaturk UniversityErzurumTurkey Department of Molecular Biology and Genetics Faculty of ScienceErzurum Technical UniversityErzurumTur-key School of Pharmaceutical Sciences Zhengzhou UniversityZhengzhouPeople’s Republic of China Department of Biology and Biological Engineering Chalmers University of TechnologyGothenburgSweden Department of Medical Biology Faculty of MedicineAtatürk UniversityErzurumTurkey Department of Molecular and Clinical Medicine University of Gothenburg and Sahlgrenska University HospitalGothenburgSweden.

Background Alzheimer’s disease(AD)is associated with metabolic abnormalities linked to critical elements of *** recently administered combined metabolic activators(CMA)to the AD rat model and observed that CMA improves the AD-associated histological parameters in the *** promotes mitochondrial fatty acid uptake from the cytosol,facilitates fatty acid oxidation in the mitochondria,and alleviates oxidative *** Here,we designed a randomised,double-blinded,placebo-controlled phase-II clinical trial and studied the effect of CMA administration on the global metabolism of AD ***-dose CMA included 12.35 g L-serine(61.75%),1 g nicotinamide riboside(5%),2.55 g N-acetyl-L-cysteine(12.75%),and 3.73 g L-carnitine tartrate(18.65%).AD patients received one dose of CMA or placebo daily during the first 28 days and twice daily between day 28 and day *** primary endpoint was the difference in the cognitive function and daily living activity scores between the placebo and the treatment *** secondary aim of this study was to evaluate the safety and tolerability of CMA.A comprehensive plasma metabolome and proteome analysis was also performed to evaluate the efficacy of the CMA in AD *** We showed a significant decrease of AD Assessment Scale-cognitive subscale(ADAS-Cog)score on day 84 vs day 0(P=0.00001,29%improvement)in the CMA ***,there was a significant decline(P=0.0073)in ADAS-Cog scores(improvement of cognitive functions)in the CMA compared to the placebo group in patients with higher ADAS-Cog *** cognitive functions in AD patients were supported by the relevant alterations in the hippocampal volumes and cortical thickness based on imaging ***,the plasma levels of proteins and metabolites associated with NAD+and glutathione metabolism were significantly improved after CMA *** Our results indicate that treatment of AD patients with CMA can lead to enhanced cognit

关键词： Alzheimer’s disease Combined metabolic activators Multi-omics Systems biology Systems medicine

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