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Fact check: Are there independent randomized controlled trials on Neuro Gold and what were their results (year, sample size)?
Executive Summary
Independent, randomized, placebo-controlled clinical trials of the gold nanocrystal therapy CNM‑Au8 — the investigational compound often associated with the trade name “Neuro Gold” in commercial materials — exist but are limited in size and show mixed results. The most-cited randomized phase 2/rescue ALS trial enrolled 45 participants and reported no significant effect on the predefined primary neurophysiological outcome while presenting exploratory analyses that suggested possible clinical benefits; other small studies report biomarker changes in 24–45 participants but differ on endpoints and independence [1] [2] [3].
1. How many randomized trials actually exist and what they called themselves — clarity on names that confuse readers
Clinical reports and conference abstracts identify CNM‑Au8 as the investigational agent studied in randomized, double‑blind, placebo‑controlled trials; marketing materials that use the brand name “Neuro Gold” do not provide independent trial data and risk conflating commercial products with the investigational compound. The accessible randomized phase 2 RESCUE‑ALS study is explicitly described as randomized and double‑blind with 45 enrolled participants, and appears in clinical trial reporting and eClinicalMedicine summaries [1] [2]. Separate small investigator‑led studies and translational biomarker studies describe cohorts of 24 to 45 patients, not large multisite pivotal trials, which means that the body of randomized evidence is small in sample size and concentrated on CNM‑Au8 rather than a consumer product named Neuro Gold [3] [2] [1].
2. What the randomized trials measured and what they actually found — endpoints, primary outcomes, and exploratory signals
The phase 2 RESCUE‑ALS randomized trial measured neurophysiological and clinical progression outcomes: its primary outcome (mean percent change in summated MUNIX) did not show a statistically significant difference between CNM‑Au8 and placebo, a result emphasized in peer‑review summaries [2]. However, exploratory analyses from the same study reported large relative differences for clinical worsening and mortality — for example a reported 55% absolute risk reduction in clinical worsening and a 60% reduction in all‑cause mortality in exploratory assessments — findings that were post‑hoc, underpowered, and therefore hypothesis‑generating rather than definitive [2]. Another randomized dataset reported a 37% absolute risk reduction and improved quality‑of‑life signals in a 45‑participant cohort in 2025, but the report’s framing and publication context require scrutiny for independence and pre‑specified endpoints [4].
3. Biomarker and mechanistic studies that support clinical reasoning — small samples, promising signals
Separate studies focused on mechanistic biomarkers found increases in NAD+/NADH ratios and improved functional measures in cohorts of about 24 participants, suggesting a plausible biological effect of gold nanocrystals on cellular bioenergetics in neurodegenerative disease models [3]. These biomarker results are important because they offer a mechanistic rationale for clinical testing, but they do not substitute for robust clinical endpoints from adequately powered randomized trials. The biomarker studies are small, often open‑label or mechanistic, and can generate useful hypotheses for larger trials but cannot by themselves establish therapeutic efficacy [3] [5].
4. Independence, publication venues, and promotional claims — who is reporting what
Some of the material labeled “Neuro Gold” seen in commerce is promotional product text that does not cite independent randomized trials and should not be equated with the investigational CNM‑Au8 trial literature; these product pages lack the peer‑reviewed methodological details required to judge trial quality [6] [7]. The randomized RESCUE‑ALS data appear in conference abstracts and journal reports that provide more transparent methods, but several positive statements come from exploratory analyses that must be interpreted with caution. Financial or promotional agendas are plausible where product labeling uses the investigational compound’s results to market a consumer supplement, so distinction between investigational CNM‑Au8 trial publications and commercial product claims is critical [1] [6].
5. Bottom line for clinicians, patients, and researchers — what remains to be done
The available randomized evidence for CNM‑Au8 comprises small phase 2 studies (about 45 patients) and mechanistic cohorts (about 24 patients) showing mixed outcomes: no significant primary endpoint in the main randomized report but promising exploratory clinical and biomarker signals that warrant larger, independent confirmatory trials. The key limitations are sample size, reliance on post‑hoc or exploratory endpoints, and the conflation of investigational drug data with commercial product claims. A clear next step is adequately powered, pre‑registered randomized trials with clinical primary endpoints and transparent reporting to resolve whether the exploratory benefits seen in small cohorts translate into clinically meaningful, reproducible effects [1] [2] [3] [6].