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

NCT07457125 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Mild to Moderate Alzheimer's Disease

Interventions

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.

Sponsors & Collaborators

  • Carrier Biomed (Suzhou) Co., Ltd

    collaborator UNKNOWN

  • Institute of Process Engineering, Chinese Academy of Sciences

    collaborator UNKNOWN

  • Xuanwu Hospital, Beijing

    lead OTHER

Principal Investigators

  • Junwei Hao, MD; PhD · Xuanwu Hospital, Beijing

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-30
Primary Completion
2028-12-30
Completion
2028-12-30

Countries

  • China

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 NCT07457125 on ClinicalTrials.gov