A 12-week, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of high temperature processed green tea extract on improvement of memory function

Ewha Womans University0 个研究点目标入组 80 人开始时间: 待定最近更新: 2019年4月23日

试验速览

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•Those who are between the ages of 40 and 65 at the time of screening
•- Those who complain subjective memory impairment (who answer yes at least 1 question at Subjective Memory Complaints Questionnaire[SMCQ], or score 2 at Global Deterioration Scale[GDS], and score 26 or more at Mini-Mental State Examination in the Korean version of the CERAD assessment packet[MMSE-KC])

•- Diagnosed with any axis 1 psychiatric disorders (depressive disorder, bipolar disorder, generalized anxiety disorder, substance-related disorder) evaluated with a structured instrument
•- Diagnosed with any major medical or neurological disorders assessed during medical history taking, physical examination or experimental tests
•- Neuropsychological tests indicate a suspected diagnosis of dementia
•- A history of traumatic brain injury with loss of consciousness or convulsion
•- Had taken psychotropic drugs within the past 1 month before screening
•- Had taken a dietary supplement for improving memory and cognitive skills within the past 1 month before screening
•- Had taken a dietary supplement made of green tea extract within the past 1 month before screening, or had consumed more than 4 cups of green tea a day
•- Had experienced allergic reaction with ingredient including green tea
•- Planning for pregnancy during the period of study participation, currently pregnant or breastfeeding
•- Participated in another clinical trial within the past 1 months before screening
•- Any contraindications to MRI (i.e., claustrophobia, metallic foreign devices in the body)

发起方