Efficacy of Bacopa monnieri Linn. on cognitive functions & alterations in blood metabolites in patients with amnestic mild cognitive impairment and early Alzheimer Disease: A double blind, randomized placebo-controlled trial - MEMOrise

Indian Council of Medical Research0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月1日

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•a. Subjects of either sex, aged 45 years to 75 years
•a. Subjects diagnosed with mild cognitive impairment or early Alzheimer disease by the consulting neurologist at AIIMS, New Delhi based on NIA-AA diagnostic criteria.
•b. Patients willing to participate in the study, who give informed written consent and are able to comply with the study requirements
•c. Subjects who are able to read and comprehend Hindi and English language properly for comprehending the cognitive assessments tests

•a. Subjects with advanced malignancies, significant systemic diseases like chronic kidney diseases, severe hepatic, pulmonary, cardiac disease and other neurologic diseases or drugs that are known to affect cognition.
•b. Patients of clinically diagnosed major psychiatric disorder (e.g., psychosis, major depression, bipolar disorder).
•c.Use of psychoactive medications that would affect subject’s ability to reliably perform neuro-cognitive testing
•d. Visual / auditory impairment that would preclude the participant from participating in or cooperating with the protocol
•e. History of intake of Bacopa monnieri or any other investigational drug or on cholinesterase inhibitors within 1 month prior to screening visit.
•f. Subjects with alcohol use as defined by National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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