What randomized controlled trials have evaluated Neurocept for Alzheimer’s and what were their primary endpoints?
Executive summary
Reporting assembled for this brief finds no detailed, peer‑reviewed randomized controlled trial (RCT) record for a drug explicitly named “Neurocept” in the provided sources; the only source that mentions Neurocept is a secondary news article claiming Phase II efficacy and plaque reduction, but that article is not corroborated by primary trial registry entries or journal publications in the dataset [1]. In the absence of primary Neurocept trial reports, the best-available evidence about what a Neurocept RCT would likely measure comes from established Alzheimer’s trial practice: cognition- and function-focused endpoints such as ADAS‑Cog, iADRS, and CDR‑SB, and safety/tolerability outcomes routinely used in Phase 2 studies [2] [3] [4].
1. What the provided reporting actually says about Neurocept trials
A single secondary-news piece asserts that “Neurocept” (described as an Eli Lilly drug in that article) produced Phase II results showing slowed cognitive decline and amyloid plaque reduction, but that piece does not provide or link to a primary trial registration or peer‑reviewed publication in the supplied material, and no clinicaltrials.gov record for “Neurocept” is present among the sources provided [1]. Given that the supplied dataset contains established trial registries and reviews of Alzheimer’s RCTs (clinicaltrials.gov records and literature summaries) but none that name Neurocept directly, the available materials do not substantiate detailed randomized trial designs, sample sizes, or prespecified primary endpoints for Neurocept beyond the news claim [5] [6] [1].
2. How Alzheimer’s RCTs typically define primary endpoints — the relevant context
Randomized trials in Alzheimer’s disease overwhelmingly use cognition-related primary outcomes: between 2007 and 2024 roughly half of RCTs reported ADAS‑Cog as a primary outcome and another substantial fraction used other cognitive measures, reflecting standard practice for demonstrating clinical benefit on cognition [2]. Several high‑profile and recent trials instead chose composite or combined cognition‑and‑function endpoints — for example iADRS was used to measure clinical decline in some antibody and disease‑modifying therapy trials, and the Clinical Dementia Rating–Sum of Boxes (CDR‑SB) is frequently the primary clinical outcome in Phase 2 and 3 programs [3] [4]. Safety and tolerability (adverse event counts, attrition rates) are standard co‑primary or primary endpoints in early phase safety‑focused studies such as Phase 2a trials [7] [3].
3. What comparable RCTs (in the dataset) measured, and why that matters for judging Neurocept claims
Examples in the supplied material illustrate endpoint choices: a Phase 2a randomized, placebo‑controlled trial of LM11A‑31 focused primarily on safety/tolerability across dose arms in 242 participants while also gathering signals on neuroprotection, reflecting early‑phase priorities [7]. Larger phase 2/3 antibody programs (e.g., lecanemab/BAN2401) used Bayesian designs and specified clinical composites (ADCOMS, iADRS) or ADAS‑Cog‑type measures as primary endpoints to quantify disease‑modifying effects on cognition and function over 12–18 months [4]. If Neurocept is positioned as a disease‑modifying anti‑amyloid agent, independent adjudication would expect similar cognitive/functional primary endpoints and biomarker secondary endpoints such as amyloid PET — but the supplied sources do not show a Neurocept trial protocol or registry to confirm such choices [4] [3].
4. Gaps, alternative interpretations, and possible motives in the reporting
The lone news report’s strong claims about plaque reduction and memory improvement could reflect early or interim Phase II readouts, company press statements, or selective emphasis in secondary coverage rather than fully adjudicated RCT results; the supplied corpus shows how trial designs and endpoints vary and underscores that press summaries can outpace peer‑reviewed dissemination [1] [2]. Without access to a clinicaltrials.gov record, a trial protocol, or a peer‑reviewed manuscript for Neurocept in the provided materials, it is not possible to state definitively which randomized trials evaluated Neurocept or to list their prespecified primary endpoints from primary sources [5] [6]. Readers should note that vested parties (sponsors, advocacy groups, trade press) can shape early narratives about efficacy before confirmatory publication, and that established trial practice usually anchors claims to cognition/function scales and safety outcomes [2] [3].
5. Bottom line
Among the provided sources there is no verifiable RCT record with protocol-level detail for a drug named Neurocept; only a secondary news article asserts Phase II positive results [1]. In practice, randomized Alzheimer’s trials most commonly set cognition or combined cognition‑and‑function scales (ADAS‑Cog, iADRS, CDR‑SB or composites) as primary endpoints and include safety/tolerability as essential outcomes — these are the metrics by which any Neurocept claim would be judged, but confirmation requires access to primary trial documents or peer‑reviewed publications that are not present in the supplied reporting [2] [3] [7].