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Dietary Supplement
Glycine + N-acetylcysteine for Alzheimer's Disease
Phase < 1
Recruiting
Led By Rajagopal V Sekhar, M.D.
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
Gradual and progressive memory loss for more than 1 year, with a Montreal Cognitive Assessment score of 10-20
Age 55-85 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 of supplementation, 12-weeks and 24-weeks after starting supplementation
Awards & highlights
Study Summary
This trial will investigate whether supplementing glycine and N-acetylcysteine can help improve cognitive decline in Alzheimer's disease.
Who is the study for?
This trial is for people aged 55-85 with Alzheimer's, showing memory loss for over a year and confirmed Tau protein in the brain. They need someone to support them during the study. Excluded are those recently hospitalized, with diabetes, untreated thyroid or liver disease, severe kidney issues, anemia, history of stroke or active heart failure/cancer (except certain skin cancers), and untreated severe psychiatric conditions.Check my eligibility
What is being tested?
The trial tests if adding glycine and N-acetylcysteine supplements can improve brain metabolism and reduce inflammation compared to alanine (placebo) in Alzheimer's patients. It will also look at how these supplements affect cognitive functions.See study design
What are the potential side effects?
Potential side effects from glycine or N-acetylcysteine may include gastrointestinal discomfort like nausea or diarrhea, possible allergic reactions, headache, drowsiness or respiratory symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been experiencing worsening memory loss for over a year and scored 10-20 on a cognitive test.
Select...
I am between 55 and 85 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0 of supplementation, 12-weeks and 24-weeks after starting supplementation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 of supplementation, 12-weeks and 24-weeks after starting supplementation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Brain glucose uptake
Brain inflammation
Cognition
Secondary outcome measures
Activities of daily living
Damage due to oxidative stress
Endothelial dysfunction
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Glycine plus N-acetylcysteineExperimental Treatment2 Interventions
Glycine and cysteine are amino-acid (protein) precursors of glutathione. Cysteine is provided as N-acetylcysteine
Group II: AlaninePlacebo Group1 Intervention
Alanine is an amino-acid (protein), and not a precursor of glutathione synthesis
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glycine
2012
Completed Phase 3
~30
N-acetylcysteine
2008
Completed Phase 4
~1290
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Alzheimer's Disease (AD) often target mitochondrial function, insulin resistance, inflammation, and brain glucose uptake. Glycine and N-acetylcysteine, for example, aim to improve mitochondrial function, reduce insulin resistance, and decrease inflammation, which are crucial as these factors are linked to cognitive decline in AD.
Enhancing brain glucose uptake is also vital since glucose is the primary energy source for brain cells, and its impaired uptake is associated with AD. Other treatments, such as antioxidants like Vitamin E, aim to reduce oxidative stress, while drugs like memantine work by regulating glutamate activity to prevent neuronal damage.
These mechanisms are important as they address the underlying pathophysiological processes of AD, potentially slowing disease progression and improving cognitive function.
The pharmacological activity of epigallocatechin-3-gallate (EGCG) on Alzheimer's disease animal model: A systematic review.
The pharmacological activity of epigallocatechin-3-gallate (EGCG) on Alzheimer's disease animal model: A systematic review.
Find a Location
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,006 Previous Clinical Trials
6,003,150 Total Patients Enrolled
The Methodist Hospital Research InstituteOTHER
275 Previous Clinical Trials
80,493 Total Patients Enrolled
Rajagopal V Sekhar, M.D.Principal InvestigatorBaylor College of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been hospitalized within the last 3 months.Your hemoglobin level is less than 11.0 grams per deciliter.I have diabetes or take medication for it.I have been experiencing worsening memory loss for over a year and scored 10-20 on a cognitive test.I have a thyroid condition that hasn't been treated.I have untreated depression or a severe psychiatric disorder.I have liver disease or my liver enzyme levels are high.I do not have a history of stroke, brain tumor, active heart failure, or active cancer except for treatable basal cell skin cancer.I am between 55 and 85 years old.Your creatinine levels are higher than 1.5 mg/dL.You have evidence of tau protein buildup in your brain on a PET scan.
Research Study Groups:
This trial has the following groups:- Group 1: Glycine plus N-acetylcysteine
- Group 2: Alanine
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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