How did Neurocept's primary endpoints differ from aducanumab's and lecanemab's endpoints?

1. What the record says about aducanumab’s endpoints — biomarker surrogate over clinical proof

Aducanumab’s regulatory story is dominated by the FDA’s use of a surrogate endpoint: clearance of amyloid beta on imaging was the principal basis for accelerated approval rather than unequivocal clinical benefit on cognitive scales. Coverage and controversy centered on whether amyloid reduction translates to meaningful patient outcomes; one review notes that aducanumab’s approval rested on the unvalidated surrogate of amyloid beta and that its clinical trials produced mixed results, with one trial meeting a clinical endpoint and another failing to do so ^{[1] [2]}.

2. How lecanemab’s primary endpoint differed — a successful clinical outcome in phase 3

Lecanemab’s CLARITY‑AD phase 3 program used a clinical primary endpoint assessing cognitive and functional decline in early Alzheimer’s disease and met that primary endpoint with statistical significance; regulatory filings and summaries emphasize that the Phase 3 data demonstrated both primary clinical benefit and supportive biomarker (amyloid) reductions ^{[1] [2]}. Commentators contrast lecanemab’s clearer phase‑3 clinical success with aducanumab’s more ambiguous trial record ^{[2] [1]}.

3. Biomarkers vs. clinical scales — the recurring tension

Across reporting and meta‑analyses, critics and regulators differ on the weight to place on amyloid reduction versus measured cognitive benefit. Reviews note both drugs reduce amyloid burden, but whether that reduction produces meaningful clinical outcomes is disputed — lecanemab showed a small but statistically significant clinical effect in its phase‑3 trial while aducanumab’s evidence was inconsistent ^{[2] [1]}. Systematic comparisons and meta‑analyses continue to stress small effect sizes on cognition despite biomarker change ^{[3] [4]}.

4. Trial design and evidence strength — why endpoints led to different regulatory outcomes

The sources make clear that lecanemab’s phase‑3 success across primary and secondary endpoints strengthened its case for approval and support, whereas aducanumab’s mixed trial outcomes and reliance on amyloid as a surrogate fueled controversy and limited acceptance; one clinical summary explicitly says lecanemab’s phase‑3 data were more definitive and promising than aducanumab’s ^{[5] [1]}. Policy reactions (coverage decisions and later pivots by manufacturers) also reflect those differences ^[6].

5. What we cannot confirm about Neurocept from these sources

Available sources do not mention Neurocept or its trial endpoints. The provided material contains no description of Neurocept’s study design, primary endpoints, or regulatory filings; therefore any comparison that claims specifics about Neurocept’s endpoints would be unsupported by the supplied reporting (not found in current reporting).

6. Why endpoint choice matters — clinical meaning, safety and policy

Endpoint selection determined not just statistical results but downstream decisions: surrogate endpoints tied to biomarker changes can speed approvals but invite payer and clinician skepticism if clinical benefit is uncertain, as happened with aducanumab; by contrast, a positive clinical primary endpoint (as with lecanemab’s phase‑3) created broader acceptance even while safety issues (ARIA) and small effect sizes remain topics of concern ^{[1] [2] [7]}.

7. Bottom line for readers and researchers

If you’re comparing Neurocept to aducanumab and lecanemab, note that the available record shows aducanumab was primarily justified on amyloid reduction (a surrogate) with mixed clinical trial outcomes, while lecanemab’s pivotal trial met a clinical primary endpoint and also reduced amyloid. Specific statements about Neurocept’s endpoints cannot be made from the supplied sources; further comparison requires primary documents or press releases about Neurocept that are not present here ^{[1] [2]}.