Study of Neural Stem Cell-Derived Exosomes in Moderate-to-Severe Early-Onset Alzheimer's Disease

This is an open-label, single-center, phase I clinical study in patients with moderate-to-severe early-onset Alzheimer's disease. The study aims to evaluate the safety, tolerability, and preliminary efficacy of neural stem cell-derived exosomes (NSC-EVs) administered by the intranasal route. A total of 9 participants will be enrolled in 3 frequency-escalation groups: once every 3 days, once every other day, and once daily, each for 28 days. Participants will undergo screening and baseline assessment, a 28-day treatment period, and follow-up visits at 4, 8, and 24 weeks after the end of treatment.

NCT Number	NCT07554872
Lead Sponsor	Shanghai Mental Health Center Collaborators: Shanghai Angecon Biotechnology Co., Ltd.
Conditions	Alzheimer Disease (AD)
Enrollment	9 participants
Start Date	2026-05
Primary Completion	2027-10-20 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2026-05-15