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Antioxidant

Glutathione Precursors for Mild Cognitive Impairment

Phase < 1
Recruiting
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Mild Cognitive Impairment
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change between 0-weeks and 12-weeks
Awards & highlights

Study Summary

This trial will investigate whether glutathione (GSH) precursors N-acetylcysteine and glycine can help improve cognition in humans with mild cognitive impairment.

Who is the study for?
This trial is for older adults with mild cognitive impairment, which is an early stage of memory loss. Participants should not have been hospitalized recently, have diabetes, severe kidney or liver disease, a history of stroke or heart issues, or untreated depression.Check my eligibility
What is being tested?
The study explores if taking supplements N-acetylcysteine and glycine can improve cognition by increasing antioxidant levels in the brain. Participants will be compared to those taking alanine over a period of 12 weeks and then observed for another 12 weeks after stopping the supplements.See study design
What are the potential side effects?
Potential side effects from N-acetylcysteine may include nausea, vomiting, rash or headache. Glycine could cause light-headedness and gastrointestinal discomfort. Alanine is generally considered safe but may also lead to stomach upset.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Mild Cognitive Impairment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between 0-weeks and 12-weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and change between 0-weeks and 12-weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cognition
Secondary outcome measures
Concentrations of Glutathione, cysteine, glycine, glutamic acid
Concentrations of malondialdehyde, F2,F3 isoprostanes
Endothelial function
+2 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: MCI-activeActive Control2 Interventions
30 Subjects with MCI will receive N-acetylcysteine and glycine for 12-weeks. ll subjects will be studied at baseline prior to supplementation, after completing 12-weeks of supplementation, and 12-weeks after stopping supplementation (i.e. at 24-weeks). Supplements are only provided for first 12-weeks.
Group II: MCI-placeboPlacebo Group1 Intervention
30 subjects will received alanine for 12-weeks. All subjects will be studied at baseline prior to supplementation, after completing 12-weeks of supplementation, and 12-weeks after stopping supplementation (i.e. at 24-weeks). Supplements are only provided for first 12-weeks

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,192 Total Patients Enrolled
The Methodist Hospital Research InstituteOTHER
272 Previous Clinical Trials
80,395 Total Patients Enrolled

Media Library

N-acetylcysteine (Antioxidant) Clinical Trial Eligibility Overview. Trial Name: NCT03493178 — Phase < 1
Mild Cognitive Impairment Research Study Groups: MCI-placebo, MCI-active
Mild Cognitive Impairment Clinical Trial 2023: N-acetylcysteine Highlights & Side Effects. Trial Name: NCT03493178 — Phase < 1
N-acetylcysteine (Antioxidant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03493178 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation recruiting individuals aged 35 and over?

"According to the inclusion criteria, only those aged between 55 and 85 are eligible for this trial. In comparison, there are 24 studies that accept participants below 18 years of age, while 533 trials encompass people over 65."

Answered by AI

To which demographic does this research opportunity extend?

"To be considered for admission to this trial, applicants must have mild cognitive impairment and fall between the ages of 55 and 85. Approximately 60 participants will ultimately be selected."

Answered by AI

Is there availability to participate in this medical trial?

"Affirmative. According to clinicaltrials.gov, this research endeavor is actively recruiting participants since April 14th 2018 and was last updated on January 28th 2022. 60 individuals are needed from one medical centre for the trial's completion."

Answered by AI

How many individuals are partaking in this experiment?

"Affirmative. Clinicaltrials.gov states that this trial is actively recruiting, having been originally posted on April 14th 2018 and last updated January 28th 2022. In total 60 patients are necessary from 1 site to fulfil the requirements of the study."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Baylor College of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Glutathione in Mild Cognitive Impairment
Rajagopal V Sekhar 2018. "Glutathione in Mild Cognitive Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03493178.
All > Mci > Mild Cognitive Impairment
~6 spots leftby Dec 2024
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