A study to evaluate effect of Bacopa monnieri (Brahmi) on memory

Phase 2

Conditions: Health Condition 1: G319- Degenerative disease of nervous system, unspecified

Registration Number: CTRI/2021/12/038731

Lead Sponsor: Indian Council of Medical Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the composite Z score of episodic memory (including the following scores of Learning Over Trials, Delayed Recall, Delayed recognition of word lists, Modified Taylor Complex Figure delayed recall) in the two groupsTimepoint: Baseline and completion of 12th week

Secondary Outcome Measures

Name	Time	Method
Change in composite z score of episodic memory in the two groupsTimepoint: after completion of 24th week;Change in composite z score of other cognitive domains (attention, executive functions, visuospatial ability and information processing speed)Timepoint: after completion of 12th week and 24th week;Frequency of self reported adverse events in the two groupsTimepoint: from baseline to completion of 12th week);Identification of metabolites, pathways and networks in MCI or early AD patients after administration of Bacopa monnieri LinnTimepoint: Baseline and 12 weeks;Proportion of patients with clinically significant improvement (defined as either more than or equal to 2 points improvement in MoCA OR more than or equal to 0.5 unit improvement in composite episodic memory z score OR statistically significant change in the ADL score) in the two groupsTimepoint: after completion of the 12th week and 24th week