Alzheimer Disease / Alanine / N-acetylcysteine · Phase EARLY_PHASE1 Trial

Glutathione, Brain Metabolism and Inflammation in Alzheimer's Disease

ClinicalTrials.gov · September 9, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry record for an active early-phase trial examining glycine and N-acetylcysteine supplementation against alanine placebo in Alzheimer's disease. No results are posted; the record documents planned enrollment, outcome measures, and study structure only.

What was studied

Early Phase 1, Interventional, Randomized, Parallel, Triple masking, Other purpose. Alzheimer Disease; age from 55 Years; to 85 Years. Intervention: Glycine plus N-acetylcysteine. Compared with: Alanine — Placebo Comparator. n = 52. 1 site: United States.

Key findings

Safety

This is a registry record with no posted results; outcomes, efficacy, and safety data are not reported.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

Early-phase uncontrolled trial (Phase 1) examining dietary supplements in Alzheimer's disease with surrogate endpoints (brain glucose uptake, inflammation) and cognition measures; no results yet reported in this registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Cognition (assessed at Day 0 of supplementation, and 12-weeks and 24-weeks after starting supplementat…); Brain glucose uptake (assessed at Done before supplementation and 24-weeks after starting supplementation); Brain inflammation (assessed at Done before supplementation and 24-weeks after starting supplementation)

DesignEarly Phase 1, Interventional, Randomized, Parallel, Triple masking, Other purpose

PopulationAlzheimer Disease; age from 55 Years; to 85 Years

Sample size52

InterventionGlycine plus N-acetylcysteine

ComparatorAlanine — Placebo Comparator

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment52

PhaseEARLY_PHASE1

Primary outcome: Cognition assessment timepointsDay 0, 12 weeks, 24 weeks after supplementation start

Primary outcome: Brain glucose uptake assessment timepointsBefore supplementation and 24 weeks after supplementation start

Primary outcome: Brain inflammation assessment timepointsBefore supplementation and 24 weeks after supplementation start

Caveats

This is a registry record with no posted results; outcomes, efficacy, and safety data are not reported.
Early Phase 1 design; no information on randomization, blinding, or control procedures provided in registry record.
Planned sample size (52) is small for drawing firm conclusions.
No comparator arm structure (active vs. placebo allocation ratio) is specified in the registry text.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Early Phase 1 design with dietary supplement interventions; no blinding or allocation concealment described.

Directness

moderate

Measures cognition, brain glucose uptake, and inflammation directly in Alzheimer's disease population.

Consistency

insufficient

Registry record only; no results posted; consistency cannot be assessed.

Risk of bias

insufficient

Registry record does not describe randomization, blinding, or allocation concealment procedures.

Sample adequacy

limited

Planned enrollment 52 participants; small sample for Phase 1 early-stage work.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT04740580). This is a study registration, not published results. Lead sponsor: Baylor College of Medicine. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: EARLY_PHASE1. Study type: INTERVENTIONAL. Enrollment: 52 participants (ESTIMATED). Conditions: Alzheimer Disease. Interventions: DIETARY_SUPPLEMENT: Glycine; DIETARY_SUPPLEMENT: N-acetylcysteine; DIETARY_SUPPLEMENT: Alanine. Primary outcome measures: Cognition , Day 0 of supplementation, and 12-weeks and 24-weeks after starting supplementation; Brain glucose uptake , Done before supplementation and 24-weeks after starting supplementation; Brain inflammation , Done before supplementation and 24-weeks after starting supplementation. Brief summary: 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Baylor College of MedicineAlzheimer DiseaseNCT04740580AlanineN-acetylcysteineGlycine