一项关于阿尔茨海默病认知与情绪营养配方的II期随机临床试验。

A Phase II Randomized Clinical Trial of a Nutritional Formulation for Cognition and Mood in Alzheimer's Disease.

作者信息

Remington Ruth, Bechtel Cynthia, Larsen David, Samar Annemarie, Doshanjh Laura, Fishman Paul, Luo Yuan, Smyers Kathleen, Page Robert, Morrell Christopher, Shea Thomas B

机构信息

University of Massachusetts Lowell, Lowell, MA, USA.

Framingham State University, Framingham, MA, USA.

出版信息

J Alzheimers Dis. 2015;45(2):395-405. doi: 10.3233/JAD-142499.

DOI:10.3233/JAD-142499

PMID:25589719

Abstract

BACKGROUND

Increasing evidence points toward the efficacy of nutritional modifications in delaying cognitive decline and mood/behavioral difficulties in Alzheimer's disease (AD). Nutritional supplementation with individual agents has shown varied results suggesting the need for combinatorial intervention.

OBJECTIVE

We set out to determine whether nutritional intervention could positively impact cognitive performance and behavioral difficulties for individuals diagnosed with AD.

METHODS

A double-blind, multi-site, phase II study (ClinicalTrials.gov NCT01320527; Alzheimer's Association Trialmatch) was conducted in which 106 individuals with AD were randomized to a nutraceutical formulation (NF; folate, alpha-tocopherol, B12, S-adenosyl methioinine, N-acetyl cysteine, acetyl-L-carnitine) or placebo for 3 or 6 months, followed by an open-label extension where participants received NF for 6 additional months.

RESULTS

The NF cohort improved versus the placebo cohort within 3 months (Clox-1 p = 0.0083, 95%CI [0.4481, 2.9343]; Dementia Rating Scale p = 0.0266, 95%CI [0.1722, 2.7171]). Caregivers reported non-significant improvements in Neuropsychiatric Inventory. Both cohorts improved or maintained baseline performance during open-label extensions. Activities of Daily Living did not change for either cohort.

CONCLUSIONS

These findings extend phase I studies where NF maintained or improved cognitive performance and mood/behavior.

摘要

背景

越来越多的证据表明，营养调整在延缓阿尔茨海默病（AD）的认知衰退以及情绪/行为障碍方面具有疗效。使用单一营养补充剂的结果各不相同，这表明需要进行联合干预。

目的

我们旨在确定营养干预是否能对被诊断为AD的个体的认知表现和行为障碍产生积极影响。

方法

开展了一项双盲、多中心的II期研究（ClinicalTrials.gov标识符：NCT01320527；阿尔茨海默病协会试验匹配项目），106名AD患者被随机分为营养制剂组（NF；包含叶酸､α-生育酚､维生素B12､S-腺苷甲硫氨酸､N-乙酰半胱氨酸､乙酰左旋肉碱）或安慰剂组，为期3或6个月，随后进入开放标签扩展期，参与者再额外接受6个月的NF。

结果

与安慰剂组相比，NF组在3个月内有所改善（Clox-1评分p = 0.0083，95%置信区间[0.4481，2.9343]；痴呆评定量表p = 0.0266，95%置信区间[0.1722，2.7171]）。护理人员报告称神经精神科问卷的改善不显著。在开放标签扩展期，两组的表现均有所改善或维持在基线水平。两组的日常生活活动能力均未改变。