CTRI/2020/08/027368已完成不适用
A randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and tolerability of LN19184 to improve cognitive function in ageing human volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change from baseline to end of the study in immediate and delayed recall
研究概览
简要总结
| This is a randomized, double-blind, placebo-controlled 2 arm clinical study to evaluate the efficacy and tolerability of LN19184 to improve cognitive function in ageing human volunteers, in which the randomized subjects will administered with the study supplement or Placebo orally once daily for 120 days |
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Males and females of 40-65 years of age with BMI range of 18 to 29 Kg/m
- •Individuals with subjective memory complaints.
- •Individuals with a score of 0-7 in Hamilton depression rating scale.
- •Female subjects of childbearing potential must be using a medically acceptable form of birth control.
- •Post-menopausal women for at least 1 year or had a hysterectomy and/or bilateral oophorectomy.
- •Adequate visual and auditory acuity to allow neuropsychological testing.
- •Subject agrees not to start any new therapies including Vitamin (Such as Folate, B12, B6 containing multivitamins) and herbal supplements during the course of the study 8)Willing and able to sign informed consent and complete all tests and procedures as listed in the protocol.
- •Has not taken any type of medicine or herbal supplements in the past 3 months related to study indication 10)Free from bipolar disorder and terminal illnesses such as cancer.
- •ECG without clinically significant abnormalities 12)General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimers disease cannot be made by the site physician at the time of the screening visit.
- •Subject should be a literate.
排除标准
- •Any significant neurologic disease (other than suspected incipient Alzheimers disease, such as Parkinson disease, stroke, TIAs, multi infarct dementia, Huntingtons disease, head trauma, chronic CNS infection 2)Subjects diagnosed with sleep apnea or related disorders.
- •History of major depression or another major psychiatric disorder within the past 6 months.
- •Any clinically significant hepatic, renal, cardiovascular, pulmonary, gastrointestinal or hematological illness or unstable medical condition which could interfere with investigational supplement safety, or absorption, distribution, metabolism and excretion, or lead to difficulty complying with the protocol.
- •Uncontrolled hypertension and diabetes mellitus.
- •Clinically significant obstructive pulmonary disease or asthma.
- •Clinically significant liver disease, coagulopathy or vitamin K deficiency within the past two years prior to screening.
- •History of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
- •History of alcohol or substance abuse or dependence within the past year.
- •Any Abnormal clinical laboratory test results or vital signs considered clinically significant in the opinion of the Investigator 11)Subjects with HIV Positive.
- •During the course of the study, participants were requested not to change their dietary habits.
- •Disability that may prevent the subject from completing all study requirements (e.g. blindness, deafness, severe language difficulty, etc.) 15)Women who are pregnant, lactating or planning to become pregnant during the study period.
- •Enrollment in another investigational study or intake of investigational drug within the previous three months.
- •Suspected or known allergy to any components of the study supplement.
- •Subjects with history of thyroid dysfunction.
- •Any condition (e.g. epilepsy) which in the opinion of the investigator makes the patient unsuitable for inclusion.
结局指标
主要结局
Change from baseline to end of the study in immediate and delayed recall
时间窗: Screening, Day 1, Day 15, Day 30, Day 60, Day 90 and Day 120
次要结局
- Change from baseline to end of the study in attention and vigilance(Screening, Day 1, Day 15, Day 30, Day 60, Day 90 and Day 120)
- Change from baseline to end of the study in reaction time(Screening, Day 1, Day 15, Day 30, Day 60, Day 90 and Day 120)
- Change from baseline to end of the study in self assessed sleep scale(Screening, Day 1, Day 15, Day 30, Day 60, Day 90 and Day 120)
- Change from baseline to end of the study in Brain derived serum bio-marker like BDNF(Screening and Day 120)
- Change from baseline to end of the study in executive function(Screening, Day 1, Day 15, Day 30, Day 60, Day 90 and Day 120)
- Change from baseline to end of the study in working memory(Screening, Day 1, Day 15, Day 30, Day 60, Day 90 and Day 120)
- Change from baseline to end of the study in Visual episodic memory(Screening, Day 1, Day 15, Day 30, Day 60, Day 90 and Day 120)
研究者
研究点 (2)
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