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

Phase 2

Not yet recruiting

Conditions: Degenerative disease of nervous system, unspecified. Ayurveda Condition: smriti khsyaya/ hrasa,

Registration Number: CTRI/2021/12/038731

Lead Sponsor: Indian Council of Medical Research

Brief Summary: Globally,there is a rise in dementia including Alzheimer’s disease (AD), which affectsover 36 million people. According to estimates, by 2050, the number coulddouble to 115 million, which could become a significant burden on society. Therehas been no effective drug approved for Alzheimer’s disease for many yearsdespite decades of research. Although Aducanumab (an anti-amyloid monoclonalantibody) is the only disease-modifying treatment approved for Alzheimer’sdisease (recent accelerated approval, awaiting phase 4 trial results), and thescientific question of whether it works is still open. It is well known that mildcognitive impairment (MCI) precedes AD. Approximately 10% of patients with MCIprogress to Alzheimerâ€™s disease every year. Mild cognitive impairment (MCI)refers to significant impairment in memory or in other cognitive domains butthe impairment is not severe enough to affect everyday life. Itis believed that treatment designed to slow or stop the progression of MCI toAlzheimer’s disease and preserve brain function will be most effective whenapplied early in the disease continuum and conserving brain function. Consideringthat conventional drug therapy is not enough to treat MCI and AD, herbsthat are traditionally used in Indian system of Medicine i.e. Ayurveda are inpopular demand worldwide. Thus, taking leads from Ayurvedic classical texts,there is an increasing interest for â€œ*medhyarasayanas*â€ which may act as memory and learning enhancers, and have significant potential in improving cognitive disorders. Brahmi (*Bacopa monnieri*) is one such herb thathas been frequently used for the treatment of anxiety, intellect, and poormemory for ages. Clinicaland preclinical studies have shownthat Brahmi enhances the retention of information and is safe for clinical use. Butthere is a paucity of studies, available in patients with MCI and AD. Additionally, the evidence for the beneficial effectof Brahmi (Bacopa monnieri), its mechanism of action in humans is not fullyknown. To the best of our knowledge, no study has explored the effect of the administration of Brahmi (Bacopa monnieri) on metabolomics among MCI patients.Metabolites are the side products of cellular regulatory or biochemicalpathways and hence have the potential to provide minute details of biologicalpathways. Untargeted metabolomics helps in understanding broad metabolomicprofiles which includes novel metabolites that can be later used as abiomarker. Thus,it is important to explore not only the clinical efficacy of Brahmi (Bacopamonnieri) in patients with MCI and early AD but also the plasma metabolitealterations with Brahmi administration through the metabolomics approach.

Thecurrent study aims to assess the efficacy of *Brahmi* (*Bacopa monnieri*Linn.) on cognitive functions in patients with amnestic mild cognitiveimpairment(MCI) and early Alzheimer Disease (AD)through a double-blind,randomized placebo-controlled trial, and perform untargeted metabolomics toidentify the global changes and canonical pathways after administration ofBrahmi. Itis hypothesized that administration of *Brahmi*(*Bacopa monnieri* Linn.) in MCI andearly AD patients for 12 weeks would lead to improvement in memory and othercognitive domains and alteration in metabolomics profile.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 76

Inclusion Criteria

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.
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

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.
Patients of clinically diagnosed major psychiatric disorder (e.g., psychosis, major depression, bipolar disorder).
c.Use of psychoactive medications that would affect subjectâ€™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.
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 groups	Baseline and completion of 12th week

Secondary Outcome Measures

Name	Time	Method
Identification of metabolites, pathways and networks in MCI or early AD patients after administration of Bacopa monnieri Linn	Baseline and 12 weeks
Change in composite z score of other cognitive domains (attention, executive functions, visuospatial ability and information processing speed)	after completion of 12th week and 24th week
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 groups	after completion of the 12th week and 24th week
Frequency of self reported adverse events in the two groups	from baseline to completion of 12th week)
Change in composite z score of episodic memory in the two groups	after completion of 24th week

Trial Locations

Locations (1): AIIMS, New Delhi
🇮🇳
South, DELHI, India
AIIMS, New Delhi
🇮🇳South, DELHI, India
Dr Anu Gupta
Principal investigator
01126549320
doctoranugupta1@gmail.com