Which clinical trials led by dr. paul cox are listed on PubMed or other registries besides ClinicalTrials.gov?
Executive summary
Dr. Paul Alan Cox is listed as a co‑author on a six‑month randomized, double‑blind Phase I trial of oral L‑serine in ALS patients that is indexed on PubMed (20 patients enrolled) [1]. Multiple organizational and news sources say his Brain Chemistry Labs has launched FDA‑approved Phase II trials of L‑serine for mild cognitive impairment/Alzheimer’s outside of ClinicalTrials.gov registration statements, but the provided sources do not list registry identifiers beyond the PubMed article for the Phase I ALS trial [1] [2].
1. The clearest published clinical trial: L‑serine Phase I in ALS
The only trial explicitly indexed and described in PubMed in the provided results is a randomized, double‑blind Phase I clinical trial of oral L‑serine in ALS patients, co‑authored by Paul A. Cox; the paper reports 20 patients enrolled with three deaths during the trial and comparison to historical controls [1]. Fortune and local coverage repeat that Cox published those six‑month Phase I safety results showing L‑serine is safe in humans [3] [4].
2. Claims of later, registered Phase II work — organizational announcements vs. registry evidence
Several institutional and advocacy sources state Brain Chemistry Labs and collaborators obtained FDA approval and launched Phase II trials of L‑serine for mild cognitive impairment or Alzheimer’s in collaboration with Houston Methodist and other centers [2] [5]. These sources frame the Phase II as underway (a 125‑patient trial begun in 2022 is mentioned by Brain Chemistry Labs) but the provided materials do not include a ClinicalTrials.gov NCT number or alternative registry entry [2] [6]. Available sources do not mention specific registry identifiers beyond the PubMed listing for the Phase I ALS study.
3. What the media and institutional pages emphasize — narrative and potential agenda
Profiles and press items emphasize ethnobotanical origins — studying island diets, BMAA hypotheses and L‑serine as a dietary protective factor — linking that narrative to the clinical work and fundraising for trials [7] [4] [5]. Those sources serve dual purposes: they publicize scientific findings and support Institute for Ethnomedicine fundraising and trial recruitment efforts, which is an implicit organizational agenda worth noting [8] [6].
4. Where researchers and readers should look next (and why registration matters)
Clinical trial registries such as ClinicalTrials.gov or international registries are the standard place to find protocol details, endpoints and identifiers; one should expect Phase II and later studies to carry registration numbers for transparency. The provided materials mention FDA approval and patient counts (e.g., 125 patients) for a Phase II trial but do not show a registry entry or NCT number in these sources, leaving a gap in publicly verifiable trial identifiers [2] [6]. Available sources do not mention registry identifiers beyond the PubMed article.
5. Competing perspectives and limits of the available record
Peer‑reviewed PubMed indexing confirms the Phase I ALS paper and its safety focus [1]. Media pieces and organizational pages present more expansive claims — Phase II launches, larger planned trials, and links to Alzheimer’s work — but those claims in the supplied material rely on institutional announcements rather than cited registry records [2] [3]. The difference matters: peer‑reviewed publication documents results; registry listings document ongoing trial structure and oversight. The supplied sources do not reconcile those two tracks with registry metadata.
6. Bottom line and recommended verification steps
The only directly citable clinical trial record in the supplied set is the PubMed Phase I L‑serine ALS trial co‑authored by Cox [1]. To confirm additional trials led by Cox and their registry listings, consult ClinicalTrials.gov and international registries for NCT or EudraCT identifiers, and check institutional trial pages at Houston Methodist or Brain Chemistry Labs for linked registry numbers; the provided sources do not contain those registry IDs [2] [6].