NCT06885567

A Phase 2 Study to Evaluate the Safety and Efficacy of BEY2153 in Patients with Early Alzheimer's Disease

A Multicenter, Randomized, Double-blind, Parallel Design, Placebo-controlled, Phase 2 Clinical Trial and Open-Label Extension Study to Evaluate the Safety and Efficacy for BEY2153 in Patients with Early Alzheimer's Disease

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: BeyondBio Inc. · Industry
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the safety and efficacy of BEY2153 in patients with early Alzheimer's Disease. Subjects who meet the inclusion and exclusion criteria will be randomized 1:1:1 to one of three treatment arms for 26 weeks administration. The extension study for additional 26 weeks will be conducted open-label with one treatment arm. Subjects will take BEY2153 orally once a day during the study.

Conditions

• Alzheimer Disease
• Alzheimer' Disease

Interventions

Type	Name	Description
DRUG	BEY2153	Participants administer once daily, PO, 26 weeks
DRUG	Placebo	Participants administer once daily, PO, 26 weeks

Timeline

• Start date: 2025-07-01
• Primary completion: 2028-07-01
• Completion: 2028-08-01
• First posted: 2025-03-20
• Last updated: 2025-03-20

Locations

3 sites across 1 country: South Korea