ACTRN12623000225617已完成未知
The effects of Solid Lipid Curcumin Particle Preparation (Longvida) on memory and cognition in adults with mild cognitive impairment: a randomised, double-blind, placebo-controlled study
Clinical Research Australia0 个研究点目标入组 80 人开始时间: 2023年3月2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
- 80
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
- 50 Years 至 85 Years（—）
- 性别
- All
入选标准
- •1. Male and females
- •2. Age 50 to 85 years
- •3. Mild cognitive impairment as determined by: (1) Montreal Cognitive Assessment (MoCA) blind score during the telephone assessment between 13 and 19, and (2) MoCA score between 19 and 25 at visit 1
- •4. BMI between 18 and 35 kg/m2
- •5. Non-smoker
- •6. No plan to commence new treatments over the study period
- •7. Understand, willing and able to comply with all study procedures
- •8. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
- •9. Normal or corrected vision with no colour blindness
- •10. Free from medical conditions which may affect ability to participate in the study
排除标准
- •1. Diagnosis of dementia based on the revised National Institute on Aging-Alzheimer’s Association (NIA/AA) criteria
- •2. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, diabetes, gallbladder disease, autoimmune disease, endocrine disease, or cancer/ malignancy
- •3. Abnormal findings on blood test as determined by (1) Aspartate Transferase or Alanine Transaminase more than 3 times the upper limit of normal, (2) Hemoglobin less than or equal to 8 g/Dl or platelet less than 100,000/mm3, or (3) adults with acute or chronic renal failure whose serum creatinine is 3 times the upper limit of normal or who requires dialysis
- •4. Diagnosis of a psychiatric disease (other than mild-to-moderate depression or anxiety) and/or neurological condition/ disease (e.g., Parkinson’s, Alzheimer’s disease)
- •5. History of paralysis, stroke or seizures or head injury (with loss of consciousness) within 6 months of study commencement.
- •6. Severe hearing and vision impairment
- •7. Regular medication intake including but not limited to anticholinergics, anti-epileptics, acetylcholinesterase inhibitors, antipsychotics, or opioids.
- •8. Change in medication in the last 3 months or expectation to change during the study duration
- •9. In the last 3 months, commenced or changed dose of nutritional and/or herbal supplements that may impact on treatment outcome
- •10. Current or 12-month history of illicit drug abuse
- •11. Alcohol intake greater than 14 standard drinks per week
- •12. Pregnant women, women who are breastfeeding or women who intended to fall pregnant.
- •13. Any significant surgeries over the last year
- •14. Planned major lifestyle change in the next 3 months
- •15. Hypersensitivity to curcumin, turmeric, or other spices
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