Zhu Carolyn W, Grossman Hillel, Neugroschl Judith, Parker Susan, Burden Amanda, Luo Xiaodong, Sano Mary
Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
James J Peters VA Medical Center, Bronx, NY, USA.
Alzheimers Dement (N Y). 2018 Nov 9;4:609-616. doi: 10.1016/j.trci.2018.09.009. eCollection 2018.
Human studies on low-dose resveratrol are scarce. This study aims to evaluate the safety, tolerability, and efficacy of an oral preparation of resveratrol, glucose, and malate (RGM) in slowing the progression of Alzheimer's disease (AD).
Thirty-nine subjects with mild to moderate AD who were free of life-threatening disease and who did not have contraindications to the use of the study product were screened. Progression of AD was measured by change in the cognitive portion of the Alzheimer's Disease Assessment Scale-cognitive subscale. Secondary outcomes included Clinician's Global Impression of Change, Mini-Mental State Examination, Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale, and Neuropsychiatric Inventory. 15 mL of the following preparation per dose, i.e., 5 g dextrose, 5 g malate, and 5 mg resveratrol, or matching placebo was ingested with an 8 oz glass of commercial unsweetened grape juice twice a day for 1 year. Group differences in the rate of change in the outcome measures were examined using generalized estimating equations.
The treatment and control groups were similar on all of the screening variables. At 12 months, change scores on Alzheimer's Disease Assessment Scale-cognitive subscale, Mini-Mental State Examination, Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale, or Neuropsychiatric Inventory all showed less deterioration in the treatment than the control group; however, none of the change scores reached statistical significance. The most common AE were falls, all in the control group. None of the falls were deemed to be study related.
Low-dose oral resveratrol is safe and well tolerated. Interpretation of the effects on clinical outcomes trajectories remains uncertain. A larger study is required to determine whether low-dose resveratrol may be beneficial.
ClinicalTrials.gov (NCT00678431), Registered 05/15/2008.
关于低剂量白藜芦醇的人体研究较少。本研究旨在评估白藜芦醇、葡萄糖和苹果酸口服制剂（RGM）在减缓阿尔茨海默病（AD）进展方面的安全性、耐受性和疗效。
筛选出39名患有轻度至中度AD且无危及生命疾病且无使用研究产品禁忌证的受试者。通过阿尔茨海默病评估量表认知子量表中认知部分的变化来衡量AD的进展。次要结局包括临床医生总体变化印象、简易精神状态检查、阿尔茨海默病协作研究日常生活活动量表和神经精神科问卷。每次服用15 mL以下制剂，即5 g葡萄糖、5 g苹果酸和5 mg白藜芦醇，或匹配的安慰剂，与8盎司市售无糖葡萄汁一起，每天服用两次，持续1年。使用广义估计方程检查结局指标变化率的组间差异。
治疗组和对照组在所有筛选变量上相似。在12个月时，阿尔茨海默病评估量表认知子量表、简易精神状态检查、阿尔茨海默病协作研究日常生活活动量表或神经精神科问卷的变化得分均显示，治疗组的恶化程度低于对照组；然而，所有变化得分均未达到统计学显著性。最常见的不良事件是跌倒，均发生在对照组。所有跌倒均被认为与研究无关。
低剂量口服白藜芦醇安全且耐受性良好。对临床结局轨迹影响的解释仍不确定。需要进行更大规模的研究来确定低剂量白藜芦醇是否有益。
ClinicalTrials.gov（NCT00678431），2008年5月15日注册。
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