ACTRN12617000945325已完成未知
A 6 month clinical trial of the efficacy and safety of Cognition Support Formulation (BioCeuticals) on cognitive function in older adults with subjective cognitive impairment.
Mrs Adele Cave0 个研究点目标入组 100 人开始时间: 2017年6月30日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 100
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
- Blinded (masking used)
入排标准
- 年龄范围
- 60 Years 至 85 Years（—）
- 性别
- All
入选标准
- •1. No diagnosis of dementia or Mild Cognitive Impairment (MCI).
- •2. Evidence of SCI as measured by:
- •Answering ‘yes’ to any of the following questions:
- •-Do you feel your memory and thinking is getting worse?
- •-Do you feel your memory and thinking has become worse over the past 2-3 years?
- •-Are you concerned about your decline in memory and thinking?
- •3. Scoring (greater than or equal to) 23 on the Montreal Cognitive Assessment (MoCA).
- •4. Normal vision or corrected to normal.
- •5. Normal hearing or aided.
- •6. Provide informed consent.
排除标准
- •1. Depression, as measured by the 30-item Geriatric Depression Scale (GDS); Participants scoring (greater than or equal to) 19 will be excluded.
- •2. Use of antidepressants/anxiolytics (if participants have been taking these, a 16-week washout is required, but only if this was the intended course of action from their usual care)
- •3. Use of psychoactive medications, alcohol intake (maximum of 14 standard drinks per week) as recommended by the Australian Department of Health.
- •4. No caffeine 2 hours prior to testing, and non-smokers.
- •5. No history of seizures or head injury (with loss of consciousness).
- •6. Allergy to study drug ingredients: ginseng, ginkgo, brahmi, or alpha-lipoic acid.
- •7. Participants taking the following ingredients: Bacopa monnieri (brahmi), Ginkgo biloba, Panax ginseng or alpha-lipoic acid (either separately or as a component of a supplement), are excluded from participation unless they have discontinued using these ingredients 8 weeks prior to testing.
- •8. Left-handedness, only for EEG testing.
- •9. Type 2 diabetics with a high fasting glucose level at baseline (>8 mmol/L, according to Diabetes Australia) or diabetics experiencing complications associated with their diabetes.
- •10. Diagnosed psychiatric disorders including: bipolar disorder, schizophrenia, personality disorders, drug and alcohol dependence or substance abuse disorders.
- •11. Presence or history of severe renal and hepatic disorders.
- •12. High dependence on medical care (including medications) due to past or current medical conditions (chronic illness), for example; cancer. Participants using Cyclophosphamide and Levothyroxine will be excluded.
- •13. A MoCA score of <23 and/or impairments on gold standard neuropsychological measures such as the RAVLT. Impairments will be defined as 2 SDs below the normative mean and/or 2 SDs below expected levels of premorbid function as measured by the TOPF.
- •14. Study neuropsychologist discretion regarding cognitive status based on neuropsychometric performance (RAVLT, MoCA etc).
- •15. Clinically significant abnormalities as per laboratory blood test results as determined by the study clinician.
- •16. Study clinician discretion regarding medical status, appropriateness of participation or concern about intervention adherence.
- •17. Commencement of the trial supplement must not occur within two weeks of receiving an immunisation so that it is possible to dissociate the effects of the supplement and the effect of the immunisations.
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