Effect of Polyamine-enriched Dietary Supplementation on Cognitive Function and Biomarkers in Elderly Individuals With Subjective Cognitive Decline
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in Memory performance from neuropsychological test
研究概览
简要总结
The overall objective of this study is to examine the effect of polyamine supplementation on cognitive performance and further characterization of individuals with subjective cognitive decline.
详细描述
Memory abilities are known to decline during aging, a process that is accelerated in pathological conditions like mild cognitive impairment (MCI) and Alzheimer's disease (AD), all of which are a growing public-health concern with devastating social and economical effects. Polyamines supplementation and corresponding up-regulation of autophagy (i.e., cellular protein degradation pathways) may be a key target of intervention against age-related memory decline. The study will investigate whether a polyamine-enriched dietary supplementation (through capsule intake) could provide positive effects on cognitive function and biomarkers of elderly individuals (60-90 years old) with subjective cognitive decline (SCD).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cognitive healthy individuals with subjective memory decline and self-reported concerns
- •60-90 years old
- •No manifest dementia (DSM-IV criteria)
- •No limitations in activities of daily living
- •Capacity for consent
排除标准
- •Gluten, histamine or wheat seedling intolerance
- •Severe neurological, internal or psychological diseases
- •Advanced heart or respiratory diseases, severe arteriosclerosis, untreated thyroid disease or diabetes
- •Malignant tumors, current or past history
- •Brain tumors, stroke
- •Disorders that impair attention
- •Coagulation disorder, Marcumar
- •Drug abuse or alcohol dependency
- •Current polyamine substitution
结局指标
主要结局
Change in Memory performance from neuropsychological test
时间窗: change from baseline after 12 month (Prior to intervention (baseline T0) and after 12 months)
Comparing memory function in subjects with polyamine intake and placebo treatment assessed prior to intervention (pre) vs. 12 month post intervention
次要结局
- Change in inflammation(change from baseline after 12 month)
- Change in Brain imaging biomarkers(change from baseline after 12 month)
- Change in polyamine concentration(change from baseline after 12 month)
- Change in Cognitive Function (from extended neuropsychological test battery)(change from baseline after 12 month)
- Change in Autophagy processes(change from baseline after 12 month)
研究者
Claudia Schwarz
Postdoctoral Researcher
Charite University, Berlin, Germany