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NCT04770220 · ClinicalTrials.gov registry record · Phase 3

An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects

A Phase 3 study of Early Alzheimer's Disease, sponsored by Alzheon.

Completed
Registry status
Phase 3
Development phase
325
Enrollment target
20
Study locations

NCT04770220 is a Phase 3 study of Early Alzheimer's Disease that has completed, run by Alzheon. The registered enrollment target is 325 participants, below the 1,056-participant average among 7 other Early Alzheimer's Disease trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 3 states.

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The verdict

NCT04770220, a Phase 3 study of Early Alzheimer's Disease, has completed, sponsored by Alzheon.

COMPLETED
Registry status
Phase 3
Development phase
325 participants
Enrollment target
20
Study locations

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

FieldValue
Enrollment Target 325 participants
Start Date 2021-05-19
Est. Completion 2024-07-29
Phase Phase 3

Sponsor

Alzheon

2 total trials

What the Registry Record Tells You About NCT04770220

The ClinicalTrials.gov registry entry for NCT04770220 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 325 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,056-participant average among 7 other Early Alzheimer's Disease trials with a reported enrollment target (69% 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 2 interventions - of which Placebo Comparator: Placebo is the first listed.

NCT04770220 reports 20 study locations spanning 3 distinct geographic areas - top geographies include Florida, California, Arizona.

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.

What interventions are being tested in trial NCT04770220?

The interventions under investigation include: Placebo Comparator: Placebo (DRUG), Experimental: ALZ-801 (DRUG).

Who is sponsoring clinical trial NCT04770220?

This trial is sponsored by Alzheon, which has 2 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.