A Randomized Double Blind Placebo Controlled Parallel Group Study to Investigate the Effect of Biokesum on Cognition Sleep Quality and Mood in Subjects having Mild Cognitive Impairment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Mean change in visual memory verbal memory executive function symbol digit coding finger tapping Stroop shifting attention continuous performance
研究概览
简要总结
Cognition and memory can decline due to aging, somatic or neurodegenerative causes; however, even healthy individuals can experience significant cognitive deterioration. Poor mood and diminished cognition are known to affect the health and quality of life significantly negatively in adults. Cognitive symptoms should therefore be regarded as a partially independent dimension of major depressive disorder (MDD), and an important target of any treatment that is initiated.
A pre-clinical study conducted by George et al. (2014) indicated standardized water extract P. minor or commercially known as Biokesum possesses antioxidant and anti-cholinesterase activity and demonstrated enhanced cognition. To date, several studies have reported the ability of P. minor extract to improve learning and memory in scopolamine-induced cognitive impairment in rodents.In one of study on older adults with Mild Cognitive Impairment (MCI) investigated the effects of 6 months supplementation of P. minus on cognition, mood, biomarkers, and brain activation. The study concluded that supplementation of 500 mg of P. minus in adults is able to improve visual related learning, reduce inflammation, increase brain activity, and improve mood thus improving quality of life.
The aim of the present study was to assess the effects of 12 weeks of 350 mg of Biokesum on cognition, mood, and sleep among mild cognitive impaired subjects from India. It was hypothesized that supplementation with Biokesum would improve cognitive performance as assessed by computer-based tasks and self-report questionnaires.
Croissance Clinical Research Pvt Ltd. is providing Clinical Trial Management supoort to the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 50.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Adults male and female aged between 50 to 75 years 2 Adults with mild cognitive impairment MCI based on Peterson criteria 3 Profile of mood state POMS score greater than 15 at the randomization or baseline day -1 visit 2 4 BMI between 20 to 29 kg m2 5 No plan to commence new treatment over the study period 6 Adults must have complete secondary school education 7 Must have the ability and willingness to sign an informed consent and comply with all study procedures.
排除标准
- •1 Adults with the history of alcohol tobacco dependence or any substance abuse 2 Pregnant and lactating women or suspected to be pregnant 3 Adults with any neurodegenerative diseases (that is Parkinsons disease dementia) 4 Adults who have been diagnosed with depressive disorder schizophrenia or score greater than 5 in Geriatric Depression Scale (GDS) 5 The patient may be excluded from the study at the PIs discretion if any significant abnormalities are found during the laboratory assessment on visit 1 (Screening day -3 to 0) 6 Adults with Attention Deficit Hyperactivity Disorder (ADHD) as this condition might interfere with cognitive function and psychosocial status 7 Adults who regularly consume traditional herbs vitamins and minerals supplementation for the past 6 months because it will jeopardize the effect of the supplement used in the study 8 Adults who has participated in other clinical trials during the previous 3 months 9 Adults who have any clinical condition according to the investigator who does not allow safe fulfilment of clinical trial protocol.
结局指标
主要结局
Mean change in visual memory verbal memory executive function symbol digit coding finger tapping Stroop shifting attention continuous performance
时间窗: Baseline, week 8 & week 12
short-term memory and Continuous Performance Test- II
时间窗: Baseline, week 8 & week 12
次要结局
- Mean change in scores for the Profile of Mood States questionnaire(Mean change in Pittsburgh Sleep Quality Index questionnaire scores, Brief Pain Inventory Short Form questionnaire scores, cognitive markers Brain Derived Neurotrophic Factor & acetyl cholinesterase, hsCRP, serum cortisol, plasma glutathione, Treatment Emergent Adverse Events)
研究者
Dr Mrutyunjaya Ganiger
Croissance Clinical Research Pvt Ltd