What are the primary risks that could delay full enrollment or compromise the integrity of the START study results?

Key enrollment‑and‑data‑integrity risks

1. Patient‑recruitment & retention hurdles – The START study hinges on enrolling 540 MCI/early‑AD subjects across the Alzheimer’s Clinical Trials Consortium (ACTC). Even at 75 % of the target, the remaining 130 patients still have to be identified, screened and retained for the full 18‑month treatment period. The pool of cognitively‑impaired volunteers is limited and often competes with parallel industry trials, so any slowdown in site activation (e.g., delays in IRB approvals, staffing shortages, or geographic imbalance of sites) can push back the enrollment timeline. High dropout or premature discontinuation—particularly in the placebo arm—would also erode statistical power and force protocol extensions or interim‑analysis read‑justments.

2. Protocol‑adherence & data‑quality concerns – Because the study is funded by the National Institute of Aging and run through a multi‑center consortium, rigorous monitoring is required. Inconsistent site‑level execution (variable imaging schedules, cognitive‑testing cadence, or medication‑dispensing compliance) can introduce site‑specific bias and increase assay variability. If the sponsor or NIH auditors detect systematic deviations, they may require data cleaning, re‑collection, or even a partial re‑run of the trial, which would delay read‑out and potentially compromise the integrity of the primary efficacy endpoints.

3. External & regulatory headwinds – Unforeseen regulatory actions (e.g., FDA feedback on safety signals) or macro‑level events such as pandemic‑related restrictions, supply‑chain interruptions for the investigational drug, or shifts in NIH funding priorities could stall enrollment or force interim protocol amendments. Any such change would raise uncertainty around the trial’s timelines and the reliability of the final analysis.

Trading implications

• Short‑term bias: Until a robust update on the remaining 25 % enrollment and site‑performance metrics is disclosed, the stock remains vulnerable to volatility. A missed enrollment window or a data‑integrity flag could trigger a sell‑off, while a smooth continuation will keep the upside narrative intact.
• Risk premium: Given the concentration of execution risk, investors should price in a modest “delay premium” (≈ 3‑5 % downside) as a hedge against an enrollment lag or data‑quality issue.
• Action: Monitor Cognition’s upcoming SEC filings, conference‑call transcripts, and ACTC site updates for any signals of recruitment bottlenecks or audit findings. If the company announces stable continuation to full enrollment, consider a modest long position; conversely, any indication of site delays or data‑clean‑up requests should prompt a defensive exit or a put‑spread to limit exposure.