NCT04770220 · Phase 3 · COMPLETED
An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects
This Phase 3 trial is testing ALZ-801, an oral drug designed to reduce toxic amyloid clusters in the brain, against a placebo in people with early Alzheimer's disease. Phase 3 means it is a large, late-stage study focused on whether the drug actually works and confirming its safety profile. Participants are randomly assigned to ALZ-801 or placebo, and neither they nor researchers know which they receive.
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're excluded 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-11-10