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临床试验/ACTRN12615001053516
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

发起方
Swinburne Univeristy

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