Effects of water-soluble mangosteen extract on cognitive function and neuropsychiatric symptoms in patients with mild to moderate Alzheimer's disease (WECAN-AD): A randomized controlled trial.

Abstract

IntroductionThe water‐soluble mangosteen pericarp extract's (WME) effect was investigated in Alzheimer's disease (AD).MethodsThe participants received 4 mg/kg/day of WME for 24 weeks (low dose, n = 33), 4 mg/kg/day for 12 weeks and then 8 mg/kg/day for 12 weeks (high dose, n = 33); or a placebo (n = 42). The outcomes were neuropsychiatric test scores, safety, tolerability, and the blood 4‐hydroxynonenal level.ResultsThe proportion of participants who achieved the minimum clinically important difference for the Alzheimer's Disease Assessment Scale–Cognitive Subscale (ADAS‐Cog; –2.6 points) at 24 weeks was significantly higher in the low‐dose group (and a trend in the high‐dose group) than in the placebo group. WME appeared safe and well tolerated. At 24 weeks, the 4‐hydroxynonenal level declined in both intervention groups. The participants with a 5% reduction in this level showed greater ADAS‐Cog improvements.ConclusionWME is a safe and well‐tolerated cognitive enhancer in AD with varying benefits across individuals based on antioxidative response.