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Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects
Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects

NCT06304883

TerminatedPhase 3

Sponsor: Alzheon Inc.

Conditions: Early Alzheimer's Disease

Interventions: Experimental: ALZ-801

Countries: United States, Canada, United Kingdom

This study is being conducted to evaluate the long-term safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is an open-label trial of treatment with ALZ-801.

Eligibility overview

Sex: ALL

Age: 50 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
Locations (41)
  • Phoenix, Arizona, United States
  • Sun City, Arizona, United States
  • Costa Mesa, California, United States
  • Lomita, California, United States
  • Sacramento, California, United States
  • Atlantis, Florida, United States
  • Maitland, Florida, United States
  • Miami Beach, Florida, United States
  • Naples, Florida, United States
  • Orlando, Florida, United States
  • Port Orange, Florida, United States
  • Stuart, Florida, United States
  • Wellington, Florida, United States
  • West Palm Beach, Florida, United States
  • Columbus, Georgia, United States
  • Fort Wayne, Indiana, United States
  • Plymouth, Massachusetts, United States
  • Toms River, New Jersey, United States
  • Albany, New York, United States
  • New York, New York, United States
  • Rochester, New York, United States
  • Greensboro, North Carolina, United States
  • Matthews, North Carolina, United States
  • Portland, Oregon, United States
  • Abington, Pennsylvania, United States
  • East Providence, Rhode Island, United States
  • Houston, Texas, United States
  • Fairfax, Virginia, United States
  • Bellevue, Washington, United States
  • Kelowna, British Columbia, Canada
  • + 11 more on CT.gov