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

Stopped early · Phase 3

Conditions studied: Early Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT06304883

Run by

Alzheon Inc.

People needed

163

Starts

2024-04-02

Expected to finish

2026-03-11

Last updated by the study team

2026-06-25

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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 may not qualify 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.

Where it is running

• Xenoscience, Inc. — Phoenix, Arizona, United States
• Banner Sun Health Research Institute — Sun City, Arizona, United States
• ATP Clinical Research — Costa Mesa, California, United States
• Torrance Clinical Research Institute — Lomita, California, United States
• Sutter Health — Sacramento, California, United States
• JEM Research Institute, Headlands Site — Atlantis, Florida, United States
• K2 Medical Research, LLC — Maitland, Florida, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• Aqualane Clinical Research — Naples, Florida, United States
• Charter Research — Orlando, Florida, United States
• Progressive Medical Research — Port Orange, Florida, United States
• ALZ Research and Treatment Center (A.R.T.C.) — Stuart, Florida, United States
• ALZ Research and Treatment Center (A.R.T.C.) — Wellington, Florida, United States
• Premiere Research Institute — West Palm Beach, Florida, United States
• Columbus Memory Center — Columbus, Georgia, United States
• Fort Wayne Neurological Center — Fort Wayne, Indiana, United States
• Headlands Research Eastern MA — Plymouth, Massachusetts, United States
• Advanced Memory Research Center — Toms River, New Jersey, United States
• Neurological Associates of Albany — Albany, New York, United States
• NYU Alzheimer's Disease Research Center — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Triad Clinical Trials — Greensboro, North Carolina, United States
• AMC Research — Matthews, North Carolina, United States
• Center for Cognitive Health — Portland, Oregon, United States
• Abington Neurological Associates — Abington, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.