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Long-term Extension of Phase 3 Study of ALZ- 801 in APOE4/4 Early AD Subjects

NCT06304883 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2025-10-31

No results posted yet for this study

Summary

This study is being conducted to evaluate the long-term safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is an open-label trial of treatment with ALZ-801.

Conditions

  • Early Alzheimer's Disease

Interventions

DRUG

Experimental: ALZ-801

ALZ-801 265 mg BID tablet orally.

Sponsors & Collaborators

  • Alzheon Inc.

    lead INDUSTRY

Principal Investigators

  • Susan Abushakra, MD · Alzheon Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-04-02
Primary Completion
2026-12-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • 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 NCT06304883 on ClinicalTrials.gov