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Investigating the Efficacy of Ergothioneine to Delay Cognitive Decline (Pilot)

NCT03641404 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-06-11

No results posted yet for this study

Summary

With the growing burden of dementia (including Alzheimer's disease), and the lack of efficacious therapies, there is an urgent need to identify new therapeutics.

Ergothioneine (ET) is a naturally occurring thiol derivative of histidine, obtained solely through diet and is able to accumulate in the body and brain, through the action of a specific transporter, OCTN1. In addition to a wide variety of in vitro and in vivo (animal) studies demonstrating the antioxidant, anti-inflammatory properties of ET, several studies have demonstrated the neuroprotective potential of ET in various cell and animal models.

Based on the ability of ET to counteract the underlying pathology of AD dementia, it is hypothesize that ET supplementation may prevent cognitive decline, especially in individuals at risk of cognitive impairment. This will be assessed using a randomized, double blinded, placebo-controlled, intervention study to test the ability of ET to delay or reverse cognitive impairment in elderly individuals with mild cognitive impairment.

Conditions

Interventions

DRUG

L-ergothioneine

Ergothioneine is naturally occurring thiol compound obtained solely from diet in humans. Ergothioneine is widely reported to be a natural antioxidant and anti-inflammatory compound. In addition we hypothesize that this compound will be beneficial in improving cognition.

DRUG

Placebo

Placebo. Study control (99% microcrystalline cellulose, 1% magnesium stearate)

Sponsors & Collaborators

  • National University of Singapore

    collaborator OTHER

  • National University Health System, Singapore

    collaborator OTHER

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Rathi Mahendran · National University of Singapore

  • Barry Halliwell · National University of Singapore

  • Christopher Chen · National University Hospital, Singapore

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Singapore

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03641404 on ClinicalTrials.gov