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NCT06304883 · ClinicalTrials.gov registry record · Phase 3
Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects
A Phase 3 study of Early Alzheimer's Disease, sponsored by Alzheon.
- Active
- Registry status
- Phase 3
- Development phase
- 163
- Enrollment target
- 20
- Study locations
NCT06304883 is a Phase 3 study of Early Alzheimer's Disease that is active but no longer recruiting, run by Alzheon. The registered enrollment target is 163 participants, below the 1,079-participant average among 7 other Early Alzheimer's Disease trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 8 states.
The verdict
NCT06304883, a Phase 3 study of Early Alzheimer's Disease, is active but no longer recruiting, sponsored by Alzheon.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 163 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Experimental: ALZ-801
Study Locations (20)
Florida
- JEM Research Institute, Headlands Site - Atlantis
- K2 Medical Research, LLC - Maitland
- Mount Sinai Medical Center - Miami Beach
- Aqualane Clinical Research - Naples
- Charter Research - Orlando
- Progressive Medical Research - Port Orange
- ALZ Research and Treatment Center (A.R.T.C.) - Stuart
- ALZ Research and Treatment Center (A.R.T.C.) - Wellington
- Premiere Research Institute - West Palm Beach
California
- ATP Clinical Research - Costa Mesa
- Torrance Clinical Research Institute - Lomita
- Sutter Health - Sacramento
Arizona
- Xenoscience, Inc. - Phoenix
- Banner Sun Health Research Institute - Sun City
New York
- Neurological Associates of Albany - Albany
- NYU Alzheimer's Disease Research Center - New York
Georgia
- Columbus Memory Center - Columbus
Indiana
- Fort Wayne Neurological Center - Fort Wayne
Massachusetts
- Headlands Research Eastern MA - Plymouth
New Jersey
- Advanced Memory Research Center - Toms River
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2024-04-02 |
| Est. Completion | 2027-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06304883
The ClinicalTrials.gov registry entry for NCT06304883 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 163 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,079-participant average among 7 other Early Alzheimer's Disease trials with a reported enrollment target (85% lower). The listed sponsor is Alzheon, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Early Alzheimer's Disease appearing as the primary indexed condition, and to 1 intervention - of which Experimental: ALZ-801 is the first listed.
NCT06304883 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT06304883 about?
NCT06304883 is a clinical study titled "Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects". 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.
What is the current status of trial NCT06304883?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 163 participants. The study started on 2024-04-02. Estimated completion is 2027-01.
What conditions does trial NCT06304883 study?
This clinical trial studies the following conditions: Early Alzheimer's Disease.
What interventions are being tested in trial NCT06304883?
The interventions under investigation include: Experimental: ALZ-801 (DRUG).
Who is sponsoring clinical trial NCT06304883?
This trial is sponsored by Alzheon, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06304883 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.