NCT07457125

The Effect of CB-Exo-A600 in Mild to Moderate Alzheimer's Disease

The Safety and Preliminary Efficacy of Exosomes Derived From Umbilical Cord Mesenchymal Stem Cell (CB-Exo-A600) in Mild to Moderate Alzheimer's Disease

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study is divided into two phases: a dose-escalation phase and an expansion cohort phase. The dose-escalation phase is a single-center study, while the expansion cohort phase is a multicenter, prospective, randomized, double-blind, placebo-controlled study.

Detailed description

Dose-Escalation Phase: A traditional "3+3" dose-escalation design will be used. Subjects will be sequentially assigned to one of three dose groups (0.75 × 10¹⁰ Particles/mL, 1.50 × 10¹⁰ Particles/mL, 3.00 × 10¹⁰ Particles/mL; 1 mL per nostril, total dose volume of 2 mL per administration, twice weekly with an interval of 3±1 days between doses, for 12 weeks). Three subjects will be enrolled in each dose group. Escalation to the next dose level will proceed if no Dose-Limiting Toxicity (DLT) is observed in these 3 subjects. If 1 out of 3 subjects experiences a DLT, an additional 3 subjects will be enrolled in the same dose group. Escalation to the next dose level will proceed if no DLT is observed in these additional 3 subjects. Expansion Cohort Phase: 24 subjects will be randomized in a 1:1 ratio to either the experimental group (exosome group) or the control group (exosome mimetic group). The dose for the experimental group in this phase will be determined by the Safety Review Committee based on the safety and efficacy data from the dose-escalation phase. The dosing frequency and duration will be 1 mL per nostril, total dose volume of 2 mL per administration, twice weekly with an interval of 3±1 days between doses, for 12 weeks.

Conditions

• Mild to Moderate Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Exosomes derived from umbilical cord mesenchymal stem cell for intranasal drop	Specification: 2.0 mL/vial. Particle concentration: (Low) 0.75 × 10¹⁰ Particles/mL, (Medium) 1.50 × 10¹⁰ Particles/mL, (High) 3.00 × 10¹⁰ Particles/mL.
DRUG	A placebo of exosomes derived from umbilical cord mesenchymal stem cell for intranasal drop	Specification: 2.0 mL/vial.

Timeline

• Start date: 2026-03-10
• Primary completion: 2028-12-30
• Completion: 2028-12-30
• First posted: 2026-03-09
• Last updated: 2026-03-09

Locations

1 site across 1 country: China