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Biomarker Effects of ALZ-801 in APOE4 Carriers With Early Alzheimer's Disease

NCT04693520 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-12-18

No results posted yet for this study

Summary

The study will investigate the effects of oral ALZ-801, in subjects with Early AD who have the APOE4/4 or APOE3/4 genotype, on the biomarkers of core AD pathology. The objectives of this study include determining the efficacy and safety/tolerability of ALZ-801. In addition, the study will evaluate the extended PK profile over 8 hours in 16 subjects after 65 weeks of treatment.

Conditions

  • Early Alzheimer's Disease

Interventions

DRUG

ALZ-801

ALZ-801 265 mg twice daily (BID)

Sponsors & Collaborators

  • Alzheon Inc.

    lead INDUSTRY

Principal Investigators

  • John Hey, PhD · Alzheon Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2023-06-20
Completion
2025-07-16
FDA Drug
Yes

Countries

  • Czechia
  • Netherlands

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 NCT04693520 on ClinicalTrials.gov