What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease include acetylcholinesterase inhibitors (such as donepezil and galantamine) and NMDA receptor antagonists (such as memantine). Acetylcholinesterase inhibitors can cause side effects like nausea, diarrhea, insomnia, muscle cramps, and fatigue. Memantine may lead to dizziness, headache, confusion, and constipation. While Glycine and N-acetylcysteine are being studied for their potential benefits in mitochondrial function and reducing inflammation, their side effects are not well-documented in the context of Alzheimer's treatment. However, they are generally considered safe with potential mild side effects such as gastrointestinal discomfort.

What prior FDA approvals exist?

FDA-approved treatments for Alzheimer's Disease primarily include cholinesterase inhibitors (donepezil, rivastigmine, and galantamine) and an NMDA receptor antagonist (memantine). These drugs aim to manage symptoms by enhancing neurotransmitter function rather than directly targeting mitochondrial function, insulin resistance, or brain glucose uptake. While antioxidants like vitamin E have been studied for their potential benefits in Alzheimer's, they are not specifically approved for these mechanisms. Current research, such as the trial involving Glycine and N-acetylcysteine, is exploring new avenues to address these underlying metabolic and inflammatory issues.

What other types of research exist?

Promising novel alternatives for Alzheimer's Disease treatment in 2024 include: 1) Sodium phenylbutyrate/taurursodiol, which has shown potential in improving mitochondrial function and reducing inflammation. 2) Antisense oligonucleotide therapies, which target specific genetic mutations and may improve cellular function. 3) Ultra-high-dose methylcobalamin, which has demonstrated neuroprotective effects. These treatments are being investigated for their potential to address key pathological features of AD, such as mitochondrial dysfunction, insulin resistance, and inflammation.

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Dietary Supplement

Glycine + N-acetylcysteine for Alzheimer's Disease

Q: What is the mechanism of action of this treatment?

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.

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

Must not have

Hospitalization in past 3 months

Known diabetes or use of anti-diabetic medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0 of supplementation, 12-weeks and 24-weeks after starting supplementation

Summary

This trial is testing a supplement called GlyNAC in patients with Alzheimer's disease. The goal is to see if GlyNAC can improve brain function by boosting a natural antioxidant that protects brain cells. Patients are selected based on specific brain scan results and cognitive tests.

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.

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.

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

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I have been experiencing worsening memory loss for over a year and scored 10-20 on a cognitive test.

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I am between 55 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been hospitalized within the last 3 months.

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I have diabetes or take medication for it.

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I have a thyroid condition that hasn't been treated.

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I have untreated depression or a severe psychiatric disorder.

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I have liver disease or my liver enzyme levels are high.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Brain glucose uptake

Brain inflammation

Cognition

Secondary study objectives

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

N-acetylcysteine

2008

Completed Phase 4

~1290

Glycine

2012

Completed Phase 3

~30

0 / 7Eligibility criteria met

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.