← Back to Search

Antioxidant

Glutathione Precursors for Mild Cognitive Impairment

Phase < 1

Waitlist Available

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

Must not have

Known liver disease, or AST/ALT greater than or equal to 2x ULN

Untreated depression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change between 0-weeks and 12-weeks

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have liver disease or my liver tests are high.

Select...

I have depression that has not been treated.

Select...

I have been hospitalized in the last 3 months.

Select...

I have been diagnosed with diabetes.

Select...

I have had a stroke, brain tumor, or suffer from active heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change between 0-weeks and 12-weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cognition

Secondary study objectives

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

0 / 6Eligibility criteria met