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Trial record 55 of 256 for:    "methodist hospital" | Recruiting, Not yet recruiting, Available Studies | Houston

Glutathione in Mild Cognitive Impairment

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ClinicalTrials.gov Identifier: NCT03493178
Recruitment Status : Recruiting
First Posted : April 10, 2018
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
Nantz National Alzhimer's Center, Houston Methodist Hospital, Houston, TX
Information provided by (Responsible Party):
Rajagopal V Sekhar, Baylor College of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment
Mild Cognitive Impairment Dietary Supplement: N- acetylcysteine plus Glycine v Placebo (alanine)

Detailed Description:
Subjects with MCI will be recruited by written informed consent using forms approved by the Baylor IRB. Subjects will stop nonvitamin supplements for 4wks before screening labs (blood count, HbA1c, glucose, lipid profile, liver profile, blood urea nitrogen, Creatinine, thyroid stimulating hormone, free T4), and for the entire 24wks duration of the study. 60 fasted subjects will have the following measures before and after 12wks of supplementation with cysteine (as N-acetylcysteine) plus glycine vs alanine: (1) Cognitive function using ADCS-PACC (Alzheimer's Disease Co-operative Study-Preclinical Alzheimer's Cognitive Composite which includes Free and Cued Selective Reminding Test, Immediate and Delayed paragraph recall score, Digit-Symbol Substitution Test, Mini mental state examination; (2) Red-cell concentrations of GSH, cysteine, glycine, glutamic acid; plasma malondialdehyde, F2/F3-isoprostanes, sICAM, sVCAM, E-selectin; endothelial function; (3) Mitochondrial glucose oxidation by calorimetry. Measures will be repeated for washout effects 12-wks after stopping supplements.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Glutathione in Mild Cognitive Impairment
Actual Study Start Date : April 14, 2018
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
MCI
30 Subjects with MCI will receive N-acetylcysteine and glycine for 12-weeks. 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.
Dietary Supplement: N- acetylcysteine plus Glycine v Placebo (alanine)
Dietary Supplement: Cysteine (as n-acetylcysteine) and glycine, or alanine. Subjects will receive 12wks of supplements.




Primary Outcome Measures :
  1. Cognition [ Time Frame: Change between 0-weeks and 12-weeks ]
    Measured using ADCS-PACC


Secondary Outcome Measures :
  1. Concentrations of Glutathione, cysteine, glycine, glutamic acid [ Time Frame: Change between 0-weeks and 12-weeks ]
    Measured in red cells

  2. Concentrations of malondialdehyde, F2,F3 isoprostanes [ Time Frame: Change between 0-weeks and 12-weeks ]
    Measured in plasma

  3. Endothelial function markers sICAM, sVCAM, E-selectin [ Time Frame: Change between 0-weeks and 12-weeks ]
    Measured in plasma

  4. Endothelial function [ Time Frame: Change between 0-weeks and 12-weeks ]
    Measured using the EndoPAT system

  5. Mitochondrial fuel oxidation in fasted and fed states [ Time Frame: Change between 0-weeks and 12-weeks ]
    Measured using calorimetry


Biospecimen Retention:   Samples Without DNA
Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects must have Mild Cognitive Impairment
Criteria
Inclusion Criteria at study entry: (1) Diagnosis of Mild Cognitive Impairment Exclusion Criteria at study entry: (1) hospitalization within past 3 months; (2) known diabetes; (3) creatinine greater than or equal to 1.5 mg/dL; (4) hemoglobin concentration less than 11 g/dL; (5) known liver disease, or AST/ALT greater than or equal to 2x ULN; (6) history of stroke, brain tumor, or active heart failure; (7) history of psychiatric disorders; (8) untreated depression.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03493178


Contacts
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Contact: Rajagopal V Sekhar, MD 7137983908 rsekhar@bcm.edu

Locations
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United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Rajagopal V Sekhar, MD    713-798-3908    rsekhar@bcm.edu   
Sponsors and Collaborators
Baylor College of Medicine
Nantz National Alzhimer's Center, Houston Methodist Hospital, Houston, TX

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Responsible Party: Rajagopal V Sekhar, Associate Professor of Medicine, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03493178     History of Changes
Other Study ID Numbers: Glutathione in MCI
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared to anyone outside of investigating team

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Acetylcysteine
N-monoacetylcystine
Glycine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Glycine Agents
Neurotransmitter Agents