VU University Medical Center, Amsterdam, The Netherlands.
Alzheimers Dement. 2010 Jan;6(1):1-10.e1. doi: 10.1016/j.jalz.2009.10.003.
To investigate the effect of a medical food on cognitive function in people with mild Alzheimer's disease (AD).
A total of 225 drug-naïve AD patients participated in this randomized, double-blind controlled trial. Patients were randomized to active product, Souvenaid, or a control drink, taken once-daily for 12 weeks. Primary outcome measures were the delayed verbal recall task of the Wechsler Memory Scale-revised, and the 13-item modified Alzheimer's Disease Assessment Scale-cognitive subscale at week 12.
At 12 weeks, significant improvement in the delayed verbal recall task was noted in the active group compared with control (P = .021). Modified Alzheimer's Disease Assessment Scale-cognitive subscale and other outcome scores (e.g., Clinician Interview Based Impression of Change plus Caregiver Input, 12-item Neuropsychiatric Inventory, Alzheimer's disease Co-operative Study-Activities of Daily Living, Quality of Life in Alzheimer's Disease) were unchanged. The control group neither deteriorated nor improved. Compliance was excellent (95%) and the product was well tolerated.
Supplementation with a medical food including phosphatide precursors and cofactors for 12 weeks improved memory (delayed verbal recall) in mild AD patients. This proof-of-concept study justifies further clinical trials.
研究一种医学食品对轻度阿尔茨海默病（AD）患者认知功能的影响。
共有 225 名未接受药物治疗的 AD 患者参与了这项随机、双盲对照试验。患者被随机分配到活性产品 Souvenaid 或对照饮料组，每天服用一次，持续 12 周。主要结局指标是韦氏记忆量表修订版的延迟口头回忆任务和 13 项改良阿尔茨海默病评估量表认知子量表在第 12 周的情况。
在 12 周时，与对照组相比，活性组在延迟口头回忆任务上的改善具有显著统计学意义（P =.021）。改良阿尔茨海默病评估量表认知子量表和其他结局评分（如临床医生访谈基于变化的印象加照顾者投入、12 项神经精神问卷、阿尔茨海默病合作研究日常生活活动、阿尔茨海默病患者生活质量）没有变化。对照组既没有恶化也没有改善。依从性极好（95%），且产品耐受性良好。
补充含有磷脂前体和辅助因子的医学食品 12 周可改善轻度 AD 患者的记忆（延迟口头回忆）。这项概念验证研究为进一步的临床试验提供了依据。
