ACTRN12615001053516已完成未知
A Randomised Controlled Trial in older adults with mild cognitive or memory impairment, investigating the Cognitive Benefits of a Combined Flavonoid/Fatty Acid Intervention and Underlying Mechanisms of Action: The COGNITIVE AGING NUTRITION and NEUROGENESIS (CANN) Trial
Swinburne Univeristy0 个研究点目标入组 240 人开始时间: 2015年10月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 55 Years 至 o limit(—)
- 性别
- All
入选标准
- •For main study:
- •Male and female, aged 55 years and over
- •Mild cognitive impairment (MCI) or subjective memory impairment (SMI) with no indication of clinical dementia or depression
- •Willing and able to provide written informed consent.
- •Understands and is willing and able to comply with all study procedures.
- •Fluent in written and spoken English.
- •In good general health including blood biochemical, haematological and urinalysis within the normal range at
- •screening (as judged by the clinical advisor)
- •Normal, or corrected to normal vision and hearing
- •Right handed, for MRI
- •Stable use of any prescribed medication for at least four weeks
- •For healthy controls sub-study:
- •The same inclusion criteria apply except that participants must not have MCI or SMI
排除标准
- •Diagnosis of Alzheimer's disease (AD) or other form of dementia or significant neurological disorder
- •Parent or sibling who developed premature dementia <60y (suggestive of a familial monogenic form of cognitive decline)
- •Past history or MRI evidence of brain damage including significant trauma, stroke, learning difficulties or serious neurological disorder, including loss of consciousness > 24 hours
- •History of alcohol or drug dependency within the last 2 years
- •Other clinically diagnosed psychiatric disorder likely to affect the cognitive measures (as judged by clinical adviser)
- •Existing diagnosed gastrointestinal disorders likely to impact on absorption of flavonoids and fatty acids (as judged by clinical adviser)
- •Major cardiovascular event, e.g. myocardial infarction or stroke, in the last 12 months
- •Carotid stents or severe stenosis
- •Known allergy to fish or any other component in the intervention supplements
- •Existing medical conditions likely to affect the study measures (as judged by clinical adviser)
- •Uncontrolled hypertension (Systolic Blood Pressure (SBP) >140mmHg, Diastolic Blood Pressure (DBP) >90mmHg)
- •BMI >40kg/m2
研究者
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