What clinicaltrial.gov records exist for L‑serine trials in ALS and mild cognitive impairment and who are the listed investigators?

1. The landscape: which clinicaltrials.gov records and published registrations exist

ClinicalTrials.gov contains a Phase IIa entry for an L‑serine study in early‑stage Alzheimer’s disease / mild cognitive impairment, documented as NCT03062449 and referenced by Alzheimer’s research summaries that describe a 9‑month, 15 g twice daily gummy formulation and an expected completion around July 2018 ^{[3] [4]}. The ALS literature describes a completed randomized, double‑blind Phase I safety trial in 20 ALS patients (6‑month dosing, 0.5–15 g twice daily) that appears in clinical trial registries and is reported in peer‑reviewed form; the clinicaltrials.gov entry for the ALS tolerability study is cited in several secondary sources and trial aggregators ^{[1] [5]}.

2. Who the records list as investigators: the public names tied to the trials

The Phase I ALS safety trial that enrolled 20 patients and later appeared as a peer‑reviewed safety report lists Elijah W. Stommel as the investigator associated with the clinicaltrials.gov record and as the lead author on the published report of the trial ^{[1] [6]}. For the Phase IIa early‑Alzheimer’s / mild cognitive impairment study, public synopses and the Alzheimer’s Drug Discovery Foundation’s writeups explicitly attribute the registered trial to A.C. Stark (Stark AC) as the named clinical investigator on the ClinicalTrials.gov listing for the LSPI‑2 trial ^{[2] [3]}. Secondary trial listings and patient‑facing sites also reference these registrations and investigators, reinforcing those attributions ^{[7] [5]}.

3. What the records say about design and safety signals

The Phase I ALS trial was randomized and double‑blind across dose groups, lasted six months, and reported that L‑serine was generally well tolerated in ALS patients with doses up to 15 g twice daily; three deaths occurred but were adjudicated as disease progression rather than drug‑related, and exploratory analyses suggested a possible dose‑related slowing of ALSFRS‑R decline (34% reduction in slope) though the cohort was small (n≈20) and efficacy was not established ^{[1] [8] [6]}. The Phase IIa early‑Alzheimer’s/mild cognitive impairment registry (NCT03062449) documents a 9‑month treatment plan using 15 g twice daily in gummy form aimed at early disease, but public summaries do not yet provide conclusive efficacy outcomes in the material provided here ^{[4] [3]}.

4. Scientific context, competing interpretations and whose interests show through

Mechanistic and preclinical studies cited in registry summaries and reviews argue that L‑serine may support autophagy‑lysosomal pathways and rescue cognitive deficits in animal models, underpinning the rationale for human trials ^{[9] [10]}. However, not all labs agree: some researchers have sounded caution about serine supplementation in Alzheimer’s because of altered serine‑related metabolic markers in disease tissue, and advocacy or commercial labs studying L‑serine (for example Brain Chemistry Labs) have promoted trial activity and safety observations—an implicit industry or advocacy interest that readers should weigh against independent academic reports ^{[11] [12] [13]}. Published trial reports and summaries (peer‑reviewed and registry entries) remain the most reliable indicators of who ran the studies and what they recorded ^{[1] [3]}.

5. Limits of the public record and the next steps for verification

The provided sources identify Elijah W. Stommel as the investigator/lead author for the ALS Phase I work and A.C. Stark as the named investigator for the NCT03062449 Phase IIa early‑Alzheimer’s/mild cognitive impairment entry, and they document dosing and safety impressions, but the materials here do not include full ClinicalTrials.gov results pages or final peer‑reviewed outcome papers for the Phase IIa registry—so definitive efficacy results and full investigator team lists beyond the named leads cannot be confirmed from the supplied snippets ^{[3] [4] [1]}. For complete, current investigator rosters and posted registry results, the ClinicalTrials.gov pages themselves and linked publications should be consulted directly.