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

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dc.contributor.authorYuluğ, Burak
dc.contributor.authorAltay, Özlem
dc.contributor.authorLi, Xiangyu
dc.contributor.authorHanoğlu, Lütfü
dc.contributor.authorÇankaya, Şeyda
dc.contributor.authorLam, Simon
dc.contributor.authorVelioğlu, Halil Aziz
dc.contributor.authorYang, Hong
dc.contributor.authorCoşkun, Ebru
dc.contributor.authorİdil, Ezgi
dc.contributor.authorNogaylar, Rahim
dc.contributor.authorÖzşimşek, Ahmet
dc.contributor.authorBayram, Cemil
dc.contributor.authorBolat, İsmail
dc.contributor.authorÖner, Sena
dc.contributor.authorTozlu, Özlem Özdemir
dc.contributor.authorArslan, Mehmet Enes
dc.contributor.authorHacımüftüoğlu, Ahmet
dc.contributor.authorYıldırım, Serkan
dc.contributor.authorArif, Muhammad
dc.contributor.authorShoaie, Saeed
dc.contributor.authorZhang, Cheng
dc.contributor.authorNielsen, Jens
dc.contributor.authorTurkez, Hasan
dc.contributor.authorBoren, Jan
dc.contributor.authorUhlen, Mathias
dc.contributor.authorMardinoğlu, Adil
dc.date.accessioned2023-07-28T12:37:35Z
dc.date.available2023-07-28T12:37:35Z
dc.date.issued2023
dc.departmentALKÜ, Fakülteler, Tıp Fakültesi, Dahili Tıp Bilimleri Bölümü
dc.description.abstractAbstract Background Alzheimer’s disease (AD) is associated with metabolic abnormalities linked to critical elements of neurodegeneration. We recently administered combined metabolic activators (CMA) to the AD rat model and observed that CMA improves the AD-associated histological parameters in the animals. CMA promotes mitochondrial fatty acid uptake from the cytosol, facilitates fatty acid oxidation in the mitochondria, and alleviates oxidative stress. Methods Here, we designed a randomised, double-blinded, placebo-controlled phase-II clinical trial and studied the efect of CMA administration on the global metabolism of AD patients. One-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 frst 28 days and twice daily between day 28 and day 84. The primary endpoint was the diference in the cognitive function and daily living activity scores between the placebo and the treatment arms. The 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 efcacy of the CMA in AD patients. Results We showed a signifcant decrease of AD Assessment Scale-cognitive subscale (ADAS-Cog) score on day 84 vs day 0 (P=0.00001, 29% improvement) in the CMA group. Moreover, there was a signifcant 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 scores. Improved cognitive functions in AD patients were supported by the relevant alterations in the hippocampal volumes and cortical thickness based on imaging analysis. Moreover, the plasma levels of
dc.identifier.doihttps://doi.org/10.1186/s40035-023-00336-2
dc.identifier.endpage23en_US
dc.identifier.issue1en_US
dc.identifier.scopusqualityQ1
dc.identifier.startpage1en_US
dc.identifier.urihttps://hdl.handle.net/20.500.12868/2298
dc.identifier.urihttps://www.scopus.com/record/display.uri?eid=2-s2.0-85146871450&origin=resultslist&sort=plf-f&src=s&sid=4c68d1b3b1ca5114c6f907d7c387d6fd&sot=b&sdt=b&s=TITLE-ABS-KEY%28Combined+metabolic+activators+improve+cognitive+functions+in+Alzheimer%E2%80%99s+disease+patients%3A+a+randomised%2C+double-blinded%2C+placebo-controlled+phase-II+trial%29&sl=169&sessionSearchId=4c68d1b3b1ca5114c6f907d7c387d6fd&relpos=0
dc.identifier.volume12en_US
dc.indekslendigikaynakScopus
dc.language.isoen
dc.relation.ispartofTranslational Neurodegeneration
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectAlzheimer’s disease
dc.subjectCombined metabolic activators
dc.subjectMulti-omics
dc.subjectSystems biology
dc.subjectSystems medicine
dc.titleCombined metabolic activators improve cognitive functions in Alzheimer’s disease patients: a randomised, double-blinded, placebo-controlled phase-II trial
dc.typeArticle

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