NCT06304883 · Phase 3 · TERMINATED
Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects
This is a long-term extension of a Phase 3 trial testing ALZ-801, an oral drug designed to reduce toxic amyloid clumps in the brain. Researchers are tracking safety and effectiveness over additional time beyond the original 78-week study. Phase 3 means the drug has already been tested for basic safety and is now being evaluated more rigorously — but it is not approved or proven effective yet.
You may qualify if
- Subject has completed the Week 78 of the Phase 3 core study (ALZ-801-AD301) while on study drug.
- Subject has a reliable study partner who has sufficient contact with the subject to be able to provide accurate information about the subject's cognitive and functional abilities.
You're excluded if
- Significant worsening of medical conditions that may preclude completion of this study.
- Evidence of symptomatic or new moderate-severe radiologic ARIA at baseline.
- Has received (or plans to receive) amyloid antibodies since completing Phase 3 core study (ALZ-801-AD301).
- Subject taking any prohibited medications per protocol.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-06-25