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

NCT04770220 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 325

Last updated 2025-11-10

Study results available
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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

  • Early Alzheimer's Disease

Interventions

DRUG

Experimental: ALZ-801

ALZ-801 tablet 265 mg once daily in the evening for the first 2 weeks, then ALZ-801 tablet 265 mg BID

DRUG

Placebo Comparator: Placebo

Placebo tablet BID

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Alzheon Inc.

    lead INDUSTRY

Principal Investigators

  • Susan Abushakra, MD · Alzheon Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-19
Primary Completion
2024-05-29
Completion
2024-07-29
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Czechia
  • France
  • Germany
  • Iceland
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04770220 on ClinicalTrials.gov