~1 spots leftby May 2025

Glutathione Precursors for Mild Cognitive Impairment

Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Waitlist Available
Sponsor: Baylor College of Medicine

Trial Summary

What is the purpose of this trial?

Elderly humans have an increased risk of dementia which begins as mild defects in memory called mild cognitive impairment. Glutathione (GSH), a key endogenous antioxidant has been linked to cognition. This exploratory study will investigate mechanisms linked to GSH for cognitive impairment (and improvement) by studying humans with mild cognitive impairment who will be evaluated 12-weeks after receiving either N-acetylcysteine and glycine (GSH precursors), or receiving alanine, and a further 12-weeks after stopping these supplements.

Research Team

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with Mild Cognitive Impairment.

Exclusion Criteria

I have liver disease or my liver tests are high.
You have a history of mental health disorders.
Hemoglobin concentration less than 11 g/dL
See 5 more

Treatment Details

Interventions

  • Alanine (Other)
  • Glycine (Antioxidant)
  • N-acetylcysteine (Antioxidant)
  • N-acetylcysteine plus Glycine (Antioxidant)
Trial OverviewThe 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials
1,044
Recruited
6,031,000+
Paul Klotman profile image

Paul Klotman

Baylor College of Medicine

Chief Executive Officer since 2010

MD, PhD

James Versalovic profile image

James Versalovic

Baylor College of Medicine

Chief Medical Officer since 2020

MD from Baylor College of Medicine

The Methodist Hospital Research Institute

Collaborator

Trials
299
Recruited
82,500+

Dr. John P. Cooke

The Methodist Hospital Research Institute

Chief Medical Officer since 2013

MD, PhD

Dr. Jenny Chang profile image

Dr. Jenny Chang

The Methodist Hospital Research Institute

Chief Executive Officer

MBBChir from University of Cambridge, MHCM from Johns Hopkins University