NCT04693520

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

A Phase 2, Single-arm Study of the Biomarker Effects of ALZ-801 in Subjects With Early Alzheimer's Disease Who Are Carriers of the ε4 Variant of the Apolipoprotein E Gene (APOE4/4 or APOE3/4)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Alzheon Inc. · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The LTE year 1 \& 2 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 LTE study are to continue longitudinal assessment of the efficacy and safety/tolerability of ALZ-801 over a total period of 4 years (2-year Core study plus 2 years of LTE). Core study: ALZ-801 265 mg twice daily (BID) in the Core Study, Weeks 0-104 LTE year 1: ALZ-801 265 mg BID in the Core Study and the Long-Term Extension (LTE, Weeks 104-208) LTE year 2: ALZ-801 265mg BID in the Core Study and LTE Year 1 (Weeks 104-156), and LTE Year 2 (Weeks 156-208)

Conditions

• Early Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	ALZ-801	ALZ-801 265 mg twice daily (BID)

Timeline

• Start date: 2020-09-30
• Primary completion: 2023-06-20
• Completion: 2025-07-16
• First posted: 2021-01-05
• Last updated: 2025-12-18

Locations

6 sites across 2 countries: Czechia, Netherlands

Regulatory

• FDA-regulated drug study