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    Combined metabolic activators improve cognitive functions in Alzheimer’s disease patients: a randomised, double-blinded, placebo-controlled phase-II trial
    (2023) Yuluğ, Burak; Altay, Özlem; Li, Xiangyu; Hanoğlu, Lütfü; Çankaya, Şeyda; Lam, Simon; Velioğlu, Halil Aziz; Yang, Hong; Coşkun, Ebru; İdil, Ezgi; Nogaylar, Rahim; Özşimşek, Ahmet; Bayram, Cemil; Bolat, İsmail; Öner, Sena; Tozlu, Özlem Özdemir; Arslan, Mehmet Enes; Hacımüftüoğlu, Ahmet; Yıldırım, Serkan; Arif, Muhammad; Shoaie, Saeed; Zhang, Cheng; Nielsen, Jens; Turkez, Hasan; Boren, Jan; Uhlen, Mathias; Mardinoğlu, Adil
    Abstract 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
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    Retraction notice to “Combined metabolic activators improve metabolic functions in the animal models of neurodegenerative diseases” [Life Sci. 314 (2023) 121325] (Life Sciences (2023) 314, (S0024320522010256), (10.1016/j.lfs.2022.121325))
    (Elsevier Inc., 2024) Türkez, Hasan; Altay, Ozlem; Yildirim, Serkan; Li, Xiangyu; Yang, Hong; Bayram, Cemil; Bolat, İsmail
    This article has been retracted: please see Elsevier Policy on Article Withdrawal (http://www.elsevier.com/locate/withdrawalpolicy). This article has been retracted at the request of Editor-in-Chief. The journal was alerted to concerns about the validity of the images shown in Figs. 3, 6 and 7 as also detailed in the following Pubpeer post: https://pubpeer.com/publications/BDEA6585A4941F7F97EB34426937FF. As per the journal policy, the authors were contacted on this matter, and they informed the journal that wrong images were included in the above-mentioned figures by accident. The authors claimed that the unintentional inclusion of the wrong images worsened the results and asked for a corrigendum in April 2023. The authors also offered to submit the raw data and physical pathology slides to be analysed by independent experts. The Editor has declined the authors' offer and decided to retract the article due to these concerns. The authors do not agree with the retraction and have maintained that the retraction of their article is not in line with Elsevier policy. They have included their explanation of the issues in the comments section of the Pubpeer post. © 2024 The Author(s)