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An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects
NCT04770220 · View on ClinicalTrials.gov ↗
Study Summary
This study is being conducted to evaluate the safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is a double-blind, randomized trial with one dose of ALZ-801 compared to placebo.
Conditions Studied
Interventions
- DRUG Placebo Comparator: Placebo
- DRUG Experimental: ALZ-801
Study Locations (20)
Florida
- JEM Research Institute, Headlands Site — Atlantis
- Bradenton Research Center — Bradenton
- Galiz Research — Hialeah
- Alphab Global Research — Jupiter
- Charter Research — Lady Lake
- K2 Medical Research, LLC — Maitland
- Miami Jewish Health — Miami
- Y & L Advance Health Care, Inc /DBA Elite Clinical Research — Miami
- Mount Sinai Medical Center — Miami Beach
California
- ATP Clinical Research — Costa Mesa
- Tilda Research — Irvine
- UCSD Shiley-Marcos Alzheimer's Disease Research Center — La Jolla
- Torrance Clinical Research Institute — Lomita
- Collaborative NeuroScience Network LLC — Long Beach
- Stanford University — Palo Alto
- SC3 Research Group — Pasadena
- Sutter Health — Sacramento
Arizona
- Xenoscience — Phoenix
- CCT Research — Scottsdale
- Banner Sun Health Research Institute — Sun City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 325 participants |
| Start Date | 2021-05-19 |
| Est. Completion | 2024-07-29 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04770220
The ClinicalTrials.gov registry entry for NCT04770220 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 325 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alzheon, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Early Alzheimer's Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo Comparator: Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04770220 reports 20 study locations spanning 3 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04770220 about?
NCT04770220 is a clinical study titled "An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects". This study is being conducted to evaluate the safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is a double-blind, randomized trial with one dose of ALZ-801 compared to placebo.
What is the current status of trial NCT04770220?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 325 participants. The study started on 2021-05-19. Estimated completion is 2024-07-29.
What conditions does trial NCT04770220 study?
This clinical trial studies the following conditions: Early Alzheimer's Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04770220?
The interventions under investigation include: Placebo Comparator: Placebo (DRUG), Experimental: ALZ-801 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04770220?
This trial is sponsored by Alzheon, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04770220 being conducted?
This trial has 20 study locations across Arizona, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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