ACTRN12624000281594尚未招募Unknown
Brain enhancement study (BES): Can optimising biochemical parameters (targets) via participation in a multi-modal lifestyle-based intervention improve cognition in amnestic mild cognitive impairment (MCI)?
Vitality Works0 个研究点目标入组 51 人开始时间: 2024年3月20日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 51
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
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 65 Years 至 85 Years（—）
- 性别
- All
入选标准
- •a.Meets the National Institute on Aging-Alzheimer’s Association workgroups diagnostic guidelines for MCI due to Alzheimer’s disease (Albert 2011), as indicated by:
- •i.A score of 1.0-1.5 standard deviations below the age standardised mean for at least two memory associated measures plus one other measure which may or may not be memory related, as
- •ii.Independence in functional activities as indicated by a score greater than 51 on the Amsterdam Instrumental Activities of Daily Living (A-IADL-Q;,
- •iii.Change in cognition as reported by the participants study companion; indicated by a score equal to 3.19 on the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) OR a change in cognition as reported by a physician,
- •b.Aged between 65 years and 85 years,
- •c.Willing and able to undertake significant behavioural change in line with the intervention guidelines
- •d.Willing and able to adhere to personal recommendations, made within the Intervention Guidelines to facilitate meeting of Biochemical and Physiological Targets
- •e.Able to participate in the entire study (24 weeks) with a study companion that knows the participant well and has daily contact with the participant,
- •f.Able to participate in the 5 ½ day Intensive workshop (Intervention: Phase 2) with their study companion.
排除标准
- •a.Known medical conditions:
- •i.Unstable angina,
- •ii.Postural hypotension (i.e. greater than 20 mmHg),
- •iii.Uncontrolled atrial or ventricular arrhythmias,
- •iv.Unstable heart failure,
- •v.Significant aortic stenosis,
- •vi.Unrecovered neurological disorder (e.g., stroke, traumatic brain injury etc.),
- •vii.Currently suffering from an acute inflammatory bowel condition (e.g., severe IBS, ulcerative colitis, Crohn’s disease or any other gastrointestinal condition likely to impede food absorption)
- •b.Currently prescribed Warfarin,
- •c.Prescribed medication known to significantly affect cognition (e.g., sedatives/hypnotics, narcotics, anticholinergics, 1st generation antihistamines),
- •d.Currently receiving chemo or radiotherapy for cancer,
- •e.Have received chemotherapy within the last 24 months,
- •f.Have undergone surgery with general anaesthesia within the last 6 months,
- •g.Indication of tobacco, alcohol, or other substance use disorder,
- •h.Concurrent participation in another study or health program,
- •i.Known allergy/intolerance to omega-3 supplements or the use of prescribed medications known to adversely interact with omega-3 supplements,
- •j.Known allergy/intolerance to ingredients within Memorease (refer to Investigational Brochure) or the use of prescribed medications known to adversely interact with ingredients within Memorease,
- •k.Likelihood of a current major depressive episode (as indicated by a score greater than 18 on the Cornell Scale for Depression in Dementia, CSDD or other psychological disorder (e.g., schizophrenia, obsessive compulsive disorder, Down syndrome),
- •l.Poorly controlled diabetes as indicated by a fasting blood glucose concentration equal to or greater than 7.0 mmol/L and/or HbA1c equal to or greater than 6.5% (48 mmol/mol),
- •m.Poorly controlled hyper/hypothyroidism as indicated by abnormal thyroid function test results,
- •n.Resting tachycardia greater than 100 bpm,
- •o.Systolic blood pressure equal to or greater than 180 and/or diastolic equal to or greater than 100 mmHg,
- •p.Uncontrolled sleep apnoea as indicated by categorisation as ‘high risk’ for sleep apnoea on the Berlin questionnaire).
- •q.Significant physical limitations or illness preventing compliance with study guidelines.
研究者
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