A Phase II, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of Two Doses of Curcumin C3 Complex Versus Placebo in Patients With Mild to Moderate Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Side effect checklist
研究概览
简要总结
The purpose of this study is to examine the safety and tolerability of curcumin, and to determine its effect on patients with mild to moderate Alzheimer's Disease (AD).
详细描述
Curcumin, a yellow substance found in the spice Turmeric, has antioxidant, non-steroidal anti-inflammatory (NSAID), and cholesterol-lowering properties, all of which make it a good candidate in the prevention and treatment of AD. The study will examine the safety and tolerability of 2 different doses of curcumin C3 complex. Blood and cerebrospinal fluid (CSF) tests will be used to examine how the curcumin is absorbed in the body, and whether it has an effect on inflammation, oxidative damage, and cholesterol levels. Participants will also be tested to determine the potential effect of curcumin on cognition, behavior, and daily function in patients with mild to moderate AD.
Participants will be randomly assigned to receive one of two doses of curcumin, or a placebo, for the initial 6 months of the trial. For the final 6 months, those receiving a placebo will be switched to one of the two doses of the drug. The 33 participants will make 7 visits to the study site over a 12-month period. These visits may include a physical and neurological examination, routine laboratory tests, lumbar puncture, and neuropsychological (mood and memory) evaluations.
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
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female at least 50 years old
- •Diagnosis of probable AD
- •No history of significant psychiatric or non-AD neurological disease
- •Proficient in English to be able to perform cognitive testing
- •Caregiver available to monitor and administer medication and to accompany patient to every clinical visit
- •On stable doses of cholinesterase inhibitors and memantine (Alzheimer's medications) for 3 months prior to enrollment
- •On stable doses of all other allowed medications for at least one month prior to starting the study medication
排除标准
- •Current or recent major psychiatric illness (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
- •Familial, autosomal dominant Alzheimer's disease due to a mutation in a known gene (Presenilin-1, Presenilin-2, or Amyloid Precursor Protein)
- •NSAIDs (e.g. ibuprofen, naproxen, etc.) taken on a regular basis (more than 3 times per week)
- •Aspirin at doses more than 325 mg per day
- •Coumadin, heparin, other anticoagulants
- •Antioxidants or other supplements including gingko biloba, coenzyme Q10, alpha-lipoic acid
- •Vitamin E at doses more than 2,000 IU per day
- •Vitamin C at doses more than 500 mg per day
结局指标
主要结局
Side effect checklist
次要结局
- Oxidative damage
- Inflammation/gliosis
- A-beta levels
- Tau levels
- Total plasma cholesterol, LDL and HDL; ApoE
- Plasma curcumin and metabolites
- Cognitive and behavioral measures