52 Participants Needed

Glycine + N-acetylcysteine for Alzheimer's Disease

RV
Overseen ByRajagopal V Sekhar, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Baylor College of Medicine

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use insulin medications.

Is the combination of Glycine and N-acetylcysteine safe for humans?

N-acetylcysteine (NAC) has been studied in patients with Alzheimer's disease and was generally well-tolerated, with no significant side effects reported in the study. However, specific safety data for the combination of Glycine and NAC is not available in the provided research.12345

How is the drug Glycine + N-acetylcysteine unique for treating Alzheimer's disease?

Glycine and N-acetylcysteine (NAC) are unique in Alzheimer's treatment because they are not standard drugs for this condition; instead, they are amino acids and antioxidants that may help reduce oxidative stress and inflammation, which are thought to contribute to Alzheimer's disease. This approach is different from traditional treatments that often target enzymes like beta-secretase involved in amyloid plaque formation.678910

What is the purpose of this trial?

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.

Research Team

RV

Rajagopal V Sekhar, MD

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

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.

Inclusion Criteria

Availability of a study partner
I have been experiencing worsening memory loss for over a year and scored 10-20 on a cognitive test.
I am between 55 and 85 years old.
See 1 more

Exclusion Criteria

I have been hospitalized within the last 3 months.
Your hemoglobin level is less than 11.0 grams per deciliter.
Pregnancy or nursing (unlikely in this population)
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline Assessment

Participants undergo imaging studies (MRI, FDG-PET and TSPO-PET scans) and cognitive, metabolic, and mitochondrial measurements before supplementation

1-2 weeks
1 visit (in-person)

Treatment

Participants receive GlyNAC or alanine placebo supplementation for 24 weeks, with cognitive and metabolic assessments at 12 and 24 weeks

24 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including repeated FDG- and TSPO-PET scans

4 weeks
1 visit (in-person)

Treatment Details

Interventions

  • Alanine
  • Glycine
  • N-acetylcysteine
Trial Overview 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.
Participant Groups
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

Glycine is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Glycine for:
  • Dietary supplement
  • Pharmaceutical ingredient
🇪🇺
Approved in European Union as Glycine for:
  • Food additive
  • Pharmaceutical excipient
🇨🇦
Approved in Canada as Glycine for:
  • Natural health product
  • Pharmaceutical ingredient

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials
1,044
Recruited
6,031,000+

The Methodist Hospital Research Institute

Collaborator

Trials
299
Recruited
82,500+

Findings from Research

In a study of 40 elderly patients with mild-to-moderate Alzheimer-type disorders, selegiline (10 mg daily) showed significant improvements in cognitive functions such as information processing, verbal fluency, and visuospatial abilities over 90 days, outperforming L-acetylcarnitine (500 mg twice daily).
Both selegiline and L-acetylcarnitine were well-tolerated, with no significant adverse effects or abnormalities detected in laboratory tests, indicating a good safety profile for both treatments.
Selegiline versus L-acetylcarnitine in the treatment of Alzheimer-type dementia.Campi, N., Todeschini, GP., Scarzella, L.[2015]
In a one-year pilot trial involving 15 Alzheimer patients, vinpocetine at doses of 30, 45, and 60 mg per day did not show any improvement in cognitive function or overall patient functioning compared to a matched control group.
Despite the lack of efficacy, vinpocetine was well-tolerated with no significant side effects reported, leading to the conclusion that it does not slow cognitive decline in Alzheimer's disease.
The safety and lack of efficacy of vinpocetine in Alzheimer's disease.Thal, LJ., Salmon, DP., Lasker, B., et al.[2019]
In a 24-week study involving 433 newly diagnosed Alzheimer's patients, the rivastigmine transdermal patch was found to be safe and tolerable, with only 2.54% experiencing serious adverse events.
Efficacy was demonstrated by a significant improvement in Mini-Mental State Examination scores, increasing from a median of 21.0 to 22.0 after 6 months, indicating potential cognitive benefits from the treatment.
Safety and tolerability of rivastigmine transdermal patch formulation in newly diagnosed patients with Alzheimer's dementia in naturalistic conditions.Pregelj, P.[2015]

References

Selegiline versus L-acetylcarnitine in the treatment of Alzheimer-type dementia. [2015]
The safety and lack of efficacy of vinpocetine in Alzheimer's disease. [2019]
Safety and tolerability of rivastigmine transdermal patch formulation in newly diagnosed patients with Alzheimer's dementia in naturalistic conditions. [2015]
Controlled trial of N-acetylcysteine for patients with probable Alzheimer's disease. [2019]
AMPA potentiator treatment of cognitive deficits in Alzheimer disease. [2022]
The NAAG'ing Concerns of Modeling Human Alzheimer's Disease in Mice. [2021]
Modeling of substrate specificity of the Alzheimer's disease amyloid precursor protein beta-secretase. [2013]
Mass spectrometry of purified amyloid beta protein in Alzheimer's disease. [2021]
Beta-secretase cleavage of Alzheimer's amyloid precursor protein by the transmembrane aspartic protease BACE. [2022]
Multiwell fluorometric and colorimetric microassays for the evaluation of beta-secretase (BACE-1) inhibitors. [2016]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security