RECRUITING

Glutathione, Brain Metabolism and Inflammation in Alzheimer's Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Alzheimer's disease (AD) is associated with significant, progressive cognitive decline. Key defects in mitochondrial fuel metabolism insulin resistance, inflammation and decreased brain glucose uptake are linked to AD. This trial will investigate the effects of supplementing glycine and N-acetylcysteine vs. alanine as placebo on these defects in AD, and examine the effects on cognition.

Official Title

Glutathione, Brain Metabolism and Inflammation in Alzheimer's Disease

Quick Facts

Study Start:2022-02-15

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04740580

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age 55-85 years; * Gradual and progressive memory loss for more than 1 year, with a Montreal Cognitive Assessment score of 10-20; * Amyloid positivity on PET scan; * Availability of a study partner.	* hospitalization in past 3 months; * use of insulin medications; * untreated thyroid disease; * creatinine levels \>1.5 mg/dL; * hemoglobin concentration \<11.0 g/dL; * known liver disease, or AST/ALT level \>2x ULN; * history of stroke, brain tumor, active heart failure or active cancer (removable basal cell cancers will not be an exclusion criteria); * untreated depression or other severe psychiatric disorders; * pregnancy or nursing (unlikely in this population)

Inclusion Criteria

Exclusion Criteria

* Age 55-85 years;
* Gradual and progressive memory loss for more than 1 year, with a Montreal Cognitive Assessment score of 10-20;
* Amyloid positivity on PET scan;
* Availability of a study partner.

* hospitalization in past 3 months;
* use of insulin medications;
* untreated thyroid disease;
* creatinine levels \>1.5 mg/dL;
* hemoglobin concentration \<11.0 g/dL;
* known liver disease, or AST/ALT level \>2x ULN;
* history of stroke, brain tumor, active heart failure or active cancer (removable basal cell cancers will not be an exclusion criteria);
* untreated depression or other severe psychiatric disorders;
* pregnancy or nursing (unlikely in this population)

Contacts and Locations

Study Contact

Rajagopal V Sekhar, M.D.

CONTACT

7137983908

rsekhar@bcm.edu

Principal Investigator

Rajagopal V Sekhar, M.D.

PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Study Locations (Sites)

Baylor College of Medicine

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

Rajagopal V Sekhar, M.D., PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-15

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2022-02-15

Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

Alzheimer Disease