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Diseases

Cognition and FDA Align on Enriched Population, Study Design, and Endpoints for Alzheimer's Disease Treatment

Strategic Insights

— 1 min read

Cognition Therapeutics, a clinical-stage company developing treatments for neurodegenerative disorders, has received final minutes from the U.S. Food and Drug Administration (FDA) concerning the end-of-Phase 2 meeting conducted on July 9, 2025. The FDA confirmed the proposed design of the Phase 3 program for zervimesine (CT1812), a treatment for Alzheimer's disease, which may support a New Drug Application (NDA) filing. Based on the FDA's feedback, the Phase 3 program will enroll adults with mild-to-moderate Alzheimer's disease who have lower levels of p-tau217 at screening. Zervimesine has been shown to arrest cognitive deterioration in this population by 95% compared to placebo, making plasma p-tau217 a predictive biomarker of robust treatment effect.

Key Takeaways:

  • The FDA has confirmed the proposed design of the Phase 3 program for zervimesine (CT1812), a treatment for Alzheimer's disease, which may support a New Drug Application (NDA) filing.
  • The Phase 3 program will enroll adults with mild-to-moderate Alzheimer's disease who have lower levels of p-tau217 at screening.
  • Zervimesine has been shown to arrest cognitive deterioration in this population by 95% compared to placebo, making plasma p-tau217 a predictive biomarker of robust treatment effect.
  • The Phase 3 program will include biomarker and imaging assessments to support clinical outcomes.
  • Participants who complete either study will be eligible to enroll in an open-label extension study.
  • Cognition Therapeutics plans to include 100mg of oral zervimesine or placebo daily for six months in the Phase 3 program.
  • Efficacy and safety will be assessed with endpoints affirmed by the FDA in the meeting minutes.

Statistics:

  • 95% increase in cognitive preservation in zervimesine-treated patients compared to placebo.
  • $30 million in grant funding from the National Institute on Aging of the National Institutes of Health (NIH) for the Phase 2 SHINE Study.
  • $81 million in grant support from the National Institute of Aging (NIA) at the National Institutes of Health for the ongoing Phase 2 START study in early Alzheimer's disease.
  • 153 adults with mild-to-moderate Alzheimer's disease participated in the Phase 2 SHINE Study.

Sources:

  • Globe Newswire, Cognition Therapeutics, Inc.
  • Cognition Therapeutics, Inc. Press Release
  • U.S. Food and Drug Administration (FDA)

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