Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 23, 2025
Open Peer Review Period: Aug 25, 2025 - Oct 20, 2025
Date Accepted: Dec 31, 2025
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Efficacy of Bacopa monnieri (Linn.) on cognitive functions & alterations in blood metabolites in patients with amnestic mild cognitive impairment and early Alzheimer’s disease: A double-blind, randomized placebo-controlled trial
ABSTRACT
Background:
Amnestic mild Cognitive Impairment (aMCI) represents a transitional stage between normal aging and Alzheimer’s disease (AD), where early intervention is critical for preserving cognition and delaying or preventing its progression to dementia. Due to limited availability of curative pharmacological treatments, there is growing interest in traditional and indigenous medicinal interventions, such as Bacopa monnieri (Linn.) (Brahmi), a widely used Ayurvedic nootropic herb. However, its efficacy in aMCI remains to be systematically evaluated through clinical trials.
Objective:
To assess the effect of Bacopa monnieri on cognitive functions and plasma metabolites in individuals with aMCI (early or prodromal AD).
Methods:
This study will employ a double-blind, randomized, placebo-controlled trial design, with 76 participants (38 per group) of aMCI diagnosed using the clinical NIA-AA 2011 criteria. They will receive either Bacopa monnieri (Linn.) (300 mg standardized plant extract) or a matched placebo daily, for 12 weeks. Comprehensive cognitive assessments (0, 12 & 24 weeks) and untargeted plasma metabolomic profiling (0, & 12 weeks) will be conducted to evaluate both cognitive changes and alterations in plasma metabolites.
Results:
The study was funded in October 2023, and the first participant was enrolled in April 2024. We have recruited 51 participants so far (August 2025). Recruitment is ongoing. Data collection will conclude in June 2026, after which data analysis will begin and be completed by September 2026, with primary findings targeted for publication in spring 2027.
Conclusions:
This research evaluates the efficacy of Bacopa monnieri (Linn.) on cognitive functions & alterations in blood metabolites in patients with amnestic mild cognitive impairment. If effective, this intervention could provide an accessible and cost-effective approach to managing early AD in resource-limited settings. Clinical Trial: The study is registered with the Clinical Trial Registry of India (CTRI/2021/12/038731).
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