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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: Completed Phase 3 study of Early Alzheimer's Disease, sponsored by Alzheon.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-Cog13) scores. The ADAS-Cog13 is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS-Cog13 consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit
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 |
What the finished NCT04770220 record still lists
NCT04770220 is an interventional study that assigns participants to a tested intervention. The registered 325 participants enrollment target is mid-sized for trials with a published cap, below the 1,056-participant average among 7 other Early Alzheimer's Disease trials with a reported enrollment target (69% lower).
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 names 20 study sites across 3 states, led by 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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