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Dietary Supplement

Glycine + N-acetylcysteine for Alzheimer's Disease

Q: Is my participation in this trial permissible?

This clinical trial is searching for 52 elderly patients with <a href="https://www.withpower.com/clinical-trials/alzheimer&#x27;s-disease">Alzheimer's disease</a>, aged between 55 and 85. In order to be eligible, participants need to have experienced a gradual decline in memory over the course of at least one year (as indicated by their Montreal Cognitive Assessment score which must lie within 10-20), have access to a study partner, and meet the age criteria mentioned previously.

Q: Are there still recruiting opportunities for this scientific trial?

This trial, which was initially posted on February 15th 2022 and recently refreshed on May 26th 2022, is currently recruiting patients according to clinicaltrials.gov.

Q: Are senior citizens being included in this experiment?

This trial is searching for elderly individuals aged between 55 and 85 to participate.

Q: What is the scope of participation in this analysis?

Affirmative. Per the clinicaltrials.gov information, this trial is actively accepting participants as of today. It was first posted on February 15th 2022 and recently modified on May 26th 2022, with a target enrollment of 52 patients at one location.

Q: What are the key aims of this research project?

This trial will assess Brain glucose uptake over the course of 0 days, 12 weeks and 24 weeks post-supplementation. Additional measurements include Endothelial dysfunction (measured by sICAM1 amd sVCAM1 levels), Mitochondrial energetics (assessed via Oroboros' high-resolution respirometer) and Oxidative stress (analyzed using TBARS and malondialdehyde concentrations).

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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 of supplementation, 12-weeks and 24-weeks after starting supplementation for reporting.

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 more

Trial 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,160 Total Patients Enrolled

The Methodist Hospital Research InstituteOTHER

274 Previous Clinical Trials

80,483 Total Patients Enrolled

Rajagopal V Sekhar, M.D.Principal InvestigatorBaylor College of Medicine

Media Library

Glycine (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04740580 — Phase < 1

Alzheimer's Disease Research Study Groups: Glycine plus N-acetylcysteine, Alanine

Alzheimer's Disease Clinical Trial 2023: Glycine Highlights & Side Effects. Trial Name: NCT04740580 — Phase < 1

Glycine (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04740580 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is my participation in this trial permissible?

"This clinical trial is searching for 52 elderly patients with Alzheimer's disease, aged between 55 and 85. In order to be eligible, participants need to have experienced a gradual decline in memory over the course of at least one year (as indicated by their Montreal Cognitive Assessment score which must lie within 10-20), have access to a study partner, and meet the age criteria mentioned previously."

Answered by AI

Are there still recruiting opportunities for this scientific trial?

"This trial, which was initially posted on February 15th 2022 and recently refreshed on May 26th 2022, is currently recruiting patients according to clinicaltrials.gov."

Answered by AI

Are senior citizens being included in this experiment?

"This trial is searching for elderly individuals aged between 55 and 85 to participate."

Answered by AI

What is the scope of participation in this analysis?

"Affirmative. Per the clinicaltrials.gov information, this trial is actively accepting participants as of today. It was first posted on February 15th 2022 and recently modified on May 26th 2022, with a target enrollment of 52 patients at one location."

Answered by AI

What are the key aims of this research project?

"This trial will assess Brain glucose uptake over the course of 0 days, 12 weeks and 24 weeks post-supplementation. Additional measurements include Endothelial dysfunction (measured by sICAM1 amd sVCAM1 levels), Mitochondrial energetics (assessed via Oroboros' high-resolution respirometer) and Oxidative stress (analyzed using TBARS and malondialdehyde concentrations)."

Answered by AI