Clinical Benefits of Antioxidative Supplement Twendee X for Mild Cognitive Impairment: A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Prospective Interventional Study

Article type: Research Article

Authors: Tadokoro, Koh^{a; 1} | Morihara, Ryuta^{a; 1} | Ohta, Yasuyuki^a | Hishikawa, Nozomi^a | Kawano, Satoko^a | Sasaki, Ryo^a | Matsumoto, Namiko^a | Nomura, Emi^a | Nakano, Yumiko^a | Takahashi, Yoshiaki^a | Takemoto, Mami^a | Yamashita, Toru^a | Ueno, Setsuko^b | Wakutani, Yosuke^b | Takao, Yoshiki^b | Morimoto, Nobutoshi^c | Kutoku, Yumiko^d | Sunada, Yoshihide^d | Taomoto, Katsushi^e | Manabe, Yasuhiro^f | Deguchi, Kentaro^g | Higashi, Yasuto^h | Inufusa, Haruhikoⁱ | You, Fukka^j | Yoshikawa, Toshikazu^k | von Greiffenclau, Markus Matuschka^l | Abe, Koji^{a; *}

Affiliations: [a] Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Okayama, Japan | [b] Department of Neurology, Kurashiki Heisei Hospital, Kurashiki, Japan | [c] Department of Neurology, Kagawa Prefectural Central Hospital, Takamatsu, Japan | [d] Department of Neurology, Kawasaki Medical School, Kurashiki, Japan | [e] Department of Neurosurgery, Ohnishi Neurological Center, Akashi, Japan | [f] Department of Neurology, National Hospital Organization Okayama Medical Center, Okayama, Japan | [g] Department of Neurology, Okayama City Hospital, Okayama, Japan | [h] Department of Neurology, Himeji Central Hospital, Himeji, Japan | [i] Division of Anti-Oxidant Research, Life Science Research Center, Gifu University, Gifu, Japan | [j] Division of Anaerobe Research, Life Science Research Center, Gifu University, Gifu, Japan | [k] Louis Pasteur Center for Medical Research, Kyoto, Japan | [l] European Medical Foundation, TIMA Est., Balzers, Liechtenstein

Correspondence: [*] Correspondence to: Prof. Koji Abe, Department of Neurology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan. Tel.: +81 86 235 7365; Fax: +81 86 235 7368; E-mail: [email protected].

Note: [1] These authors contributed equally to this work.

Abstract: Oxidative stress is part of the entire pathological process that underlies the development of Alzheimer’s disease (AD), including the mild cognitive impairment (MCI) stage. Twendee X (TwX) is a supplement containing a strong antioxidative mix of eight antioxidants, which has been shown to have a clinical and therapeutic benefit in AD model mice. Here, we conducted a multicenter, randomized, double-blind, and placebo-controlled prospective interventional study to evaluate the efficacy of TwX in mitigating MCI. The primary outcomes were differences in Mini-Mental State Examination (MMSE) and Hasegawa Dementia Scale-revised (HDS-R) scores between baseline and six months for placebo and TwX groups. Seventy-eight subjects with MCI were randomized into placebo (n = 37) and TwX (n = 41) groups. MMSE scores at six months differed significantly between the TwX and placebo groups (p = 0.018), and HDS-R scores for the TwX group exhibited a significant improvement at six months relative to baseline (p = 0.025). The TwX group did not show any change in affective or activities of daily living scores at six months. The present study indicates that strong antioxidative supplement TwX is clinical beneficial for cognitive function in subjects with MCI.

Keywords: Dementia, dietary supplement, mild cognitive impairment, oxidative stress, randomized controlled trial

DOI: 10.3233/JAD-190644

Journal: Journal of Alzheimer's Disease, vol. 71, no. 3, pp. 1063-1069, 2019