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

Completed · Phase 3 · Has a placebo group

Conditions studied: Early Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT04770220

Run by

Alzheon Inc.

People needed

325

Starts

2021-05-19

Expected to finish

2024-07-29

Last updated by the study team

2025-11-10

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of MCI or Mild Dementia due to AD consistent with the National Institute on Aging-Alzheimer's Association (NIA-AA) Working Group Criteria.
• Homozygous for the ε4 allele of the apolipoprotein E gene (APOE4/4).
• MMSE score at Screening of 22 to 30 (inclusive).
• CDR - Global score of 0.5 or 1 and CDR Memory Box Score of ≥ 0.5.
• RBANS delayed memory index score ≤ 85.
• Evidence of progressive memory loss over the last 12 months per investigator assessment

You may not qualify if…

• Brain magnetic resonance imaging (MRI) indicative of significant abnormality per central reader, other than AD related atrophy. Computed tomography (CT) scan acceptable for subjects who cannot undergo MRI.
• Diagnosis of neurodegenerative disorder other than AD.
• Diagnosis of major depressive disorder (MDD) within one year prior to screening.
• Currently taking memantine or has taken memantine within 12 weeks prior to the Baseline Visit.
• History of suicidal behavior within one year prior to screening or has ongoing suicidal ideation.
• History of seizures, excluding febrile seizures of childhood or a single distant seizure (> 5 years).
• Medically confirmed history of recent cerebral infarct or transient ischemic attack within one year prior to screening.

Where it is running

• CCT Research — Scottsdale, Arizona, United States
• Banner Sun Health Research Institute — Sun City, Arizona, United States
• ATP Clinical Research — Costa Mesa, California, United States
• Tilda Research — Irvine, California, United States
• UCSD Shiley-Marcos Alzheimer's Disease Research Center — La Jolla, California, United States
• Torrance Clinical Research Institute — Lomita, California, United States
• Collaborative NeuroScience Network LLC — Long Beach, California, United States
• Stanford University — Palo Alto, California, United States
• SC3 Research Group — Pasadena, California, United States
• Sutter Health — Sacramento, California, United States
• JEM Research Institute, Headlands Site — Atlantis, Florida, United States
• Bradenton Research Center — Bradenton, Florida, United States
• Galiz Research — Hialeah, Florida, United States
• Alphab Global Research — Jupiter, Florida, United States
• Charter Research — Lady Lake, Florida, United States
• K2 Medical Research, LLC — Maitland, Florida, United States
• Miami Jewish Health — Miami, Florida, United States
• Y & L Advance Health Care, Inc /DBA Elite Clinical Research — Miami, 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
• Headlands Research Orlando — Orlando, Florida, United States
• Advanced Research Consultants — Palm Beach Gardens, Florida, United States
• Quantum CNS Clinical Research — Pompano Beach, Florida, United States
• Xenoscience — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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