Phase II Study of Curcumin Formulation (Longvida) or Placebo on Plasma Biomarkers and Mental State in Moderate to Severe Alzheimer's Disease or Normal Cognition
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- To determine if curcumin formulation affects mental capacity in Alzheimer's patients based on mental exams
研究概览
简要总结
Curcumin is shown to impact several different pathways of neuroprotection, however clinical trials have not shown positive results, due to the poor bioavailability of curcumin. This study is designed to determine efficacy and safety of high-bioavailability curcumin formulation (Longvida) in subjects with Alzheimer's disease.
详细描述
Curcumin is a polyphenolic molecule that comprises approximately 3-5% of turmeric (Curcuma longa) root, giving the spice its characteristic yellow color. Because of its anti-inflammatory, anti-amyloid, and antioxidant properties, curcumin has shown positive effects in animal models of Alzheimer's disease (AD). However, a six month human study was conducted with unformulated curcumin showing insignificant trends, due to limited bioavailability and brain permeability of unformulated curcumin. In animal models of AD, oral dosing of solid-lipid curcumin particle (SLCP or Longvida) significantly reduced memory deficit and impacted biomarkers better than unformulated curcumin. This study is to determine the potential efficacy and safety of highly absorbed SLCP curcumin in subjects with AD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female age ≥
- •Diagnosed with probable AD using NINDS-ADRDA research criteria. MMSE score ≥5 and ≤
- •No history of significant psychiatric or non-AD neurological disease.
- •An available caregiver to monitor and administer medication and to accompany the subject to every clinical visit.
- •On stable doses of concomitant medications for at least one month prior to starting study medication.
排除标准
- •Current or recent major psychiatric illness that meets DSM-IV criteria (i.e. bipolar disorder, schizophrenia).
- •Significant uncontrolled systemic illness (i.e. chronic renal failure, chronic liver disease, poorly controlled diabetes, or poorly controlled congestive heart failure).
- •Recent history of gastrointestinal bleeding or ulceration.
- •Alcoholism or substance abuse within the past year per DSM-IV criteria.
- •Familial, autosomal dominant Alzheimer's disease due to a mutation in a known gene (Presenilin-1, Presenilin-2, or Amyloid Precursor Protein).
结局指标
主要结局
To determine if curcumin formulation affects mental capacity in Alzheimer's patients based on mental exams
时间窗: 60 days
次要结局
- To determine if curcumin formulation changes blood concentrations of amyloid-beta(60 days)
研究者
Dr Paresh Doshi
administrator
Jaslok Hospital and Research Centre