Effect of Elderberry Juice on Cognition and Inflammation in Patients With Mild Cognitive Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Visuospatial Problem Solving Battery (VSP)
研究概览
简要总结
Elderberries (Sambuci fructus) have been shown in a number of studies to have significant anti-inflammatory and antioxidant effects. Multiple human and animal studies have supported the anti-inflammatory and antioxidant effects of elderberry preparations and it has been used in natural medicine for hundreds of years. Studies examining factors that may decrease the risk of Alzheimer's disease have revealed that drinking juices with similar properties to elderberries is one of the most reliable way to decrease risk. As such the investigators wish to determine the effects of elderberry juice on cognitive decline in a group of subjects at high risk for Alzheimer's disease, those with mild cognitive impairment. Elderberry juice is a commercially available nutritional supplement and easily available to this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CDR score of 0.5
- •MMSE of at least 24
- •Age 50 or older
排除标准
- •Known history of sensitivity to elderberry products.
- •Diabetes.
- •Bleeding disorder.
- •Current Pregnancy.
- •Known allergy to honeysuckle.
- •Currently making changes to other drugs that might affect cognitive performance (subjects showing the greatest cognitive decline and other signs of Alzheimer's disease may be prescribed cholinesterase inhibitors as this is a standard of care for Alzheimer's disease but not MCI).
- •Presence of any condition the health professional believes will impair ability to complete study procedures (ex. terminal illness, comorbid major psychiatric disorders such as schizophrenia, or drug abuse).
- •Potentially confounding neurodegenerative diseases (e.g. MS).
结局指标
主要结局
Visuospatial Problem Solving Battery (VSP)
时间窗: 12 wks, 6 mos
Problem solving task for detecting non-memory impairments in MCI. Change in score is the outcome measure. The task is a timed task, with the outcome measured in seconds. Each item was allowed 240 seconds for solution, with times averaged for items. Therefore, there was a range of 0-240 with lower being better.
次要结局
- Anagrams(12 wks, 6 mos)
- Clinical Dementia Rating (CDR) Scale(12 wks, 6 mos)
- Mini-Mental State Examination (MMSE)(12 wks, 6 mos)
- Hopkins Verbal Learning Test (HVLT)(12 wks, 6 mos)
- Rey Complex Figure Task (Rey)(12 wks, 6 mos)
- Instrumental Activities of Daily Living Scale (IADLS)(12 wks, 6 mos)
- Boston Naming Test (BNT)(12 wks, 6 mos)
研究者
David Beversdorf
Associate Professor: Radiology, Neurology, Psychology
University of Missouri-Columbia