A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Study to Evaluate the Efficacy and Safety of NEUROCAF in healthy elderly subjects at risk of developing Parkinson’s disease.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Changes in Bio markers of Parkinsons Disease
研究概览
简要总结
This is a randomized (1:1), double-blind, placebo-controlled, parallel group clinical study. Healthy subjects aged 55-65 years with and meeting all inclusion and no exclusion criteria will sign a written informed consent and will be enrolled in the study.After passing the eligibility criteria, subjects will be randomized in 50:50 ratio into 2 treatment arms to receive NEUROCAF or placebo capsules for a period of 12 weeks.The subject will arrive at the study site in a fasted state and blood samples will be collected for laboratory assessments .Cerebrospinal fluid (CSF) will be collected by lumbar puncture for the bio marker analysis Post blood sample collection, the subjects will undergo various assessments to evaluate their physical performance. Fatigue levels of subjects will be also assessed . The subjects will visit their designated study site on 3 different occasions during the 12 - week study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Should not be an any medication for cognition and other neurological disorders 2.Post-menopausal women 3.Must be willing and able to give informed consent and comply with the study procedures.
排除标准
- •1.Subjects with history of Neurogenerative disorder, including Parkinson’s disorder,Psychiatric disorders ,Uncontrolled / serious medical illness including diabetes, liver disease, hypertension,Cardiac Disease/Neurological Problems,Auto-immune disease (rheumatoid arthritis, lupus, type 1 diabetes),Gastrointestinal tract bleeding / peptic ulcer disease 2.Subjects having symptoms of viral infection, including COVID-19 infection 3.Subjects who may be allergic to any of the natural constituents of the Investigational Product.
- •4.Known HIV or Hepatitis B positive or any other immuno-compromised state 5.Subjects on any other medical or clinical investigation or on any nutrition supplements and dietary regime.
- •6.Subjects visually or mentally handicapped or having difficulty to communicate 7.History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
- •8.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
- •9.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
结局指标
主要结局
Changes in Bio markers of Parkinsons Disease
时间窗: Day 0, Day 84
次要结局
- Changes in geriatric parameters
- Safety of NEUROCAF(Day 0, Day 42, Day 84)