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.
Male or postmenopausal female, aged 50 to 75 years.
Meets the 2011 NIA-AA criteria for probable Alzheimer's disease dementia.
Age at onset ≤65 years.
CMMS score 5-20
Dementia due to causes other than Alzheimer's disease.
Brain MRI showing any of the following: Fazekas white matter hyperintensity score >2; more than 2 lacunar infarcts >1.5 cm; lacunar infarcts involving critical regions such as the thalamus, hippocampus, entorhinal cortex, or parahippocampal region; cerebral hemorrhage, subdural hematoma, aneurysm, arteriovenous malformation, intracranial mass lesion, or other clinically significant structural abnormalities.
Allergy to stem cell-derived exosomes or PET examination.
Severe psychiatric disorder or symptoms.
Shanghai Mental Health Center
Lead sponsor
Shanghai Angecon Biotechnology Co., Ltd.
Collaborator