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

Eligibility criteria

* Inclusion Criteria:
* 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
* Stable dose for at least 2 months before enrollment if receiving pro-cognitive or psychiatric medications.
* Primary school education or above and able to complete study-required cognitive assessments.
* Hachinski Ischemic Score ≤4.
* GDS-30 total score ≤10.
* Screening brain MRI+DWI+SWI meeting protocol-defined cerebrovascular exclusion thresholds and no major structural abnormalities inconsistent with Alzheimer's disease.
* Positive amyloid pathology confirmed by Aβ-PET at screening or before enrollment.
* Adequate vision and hearing to complete assessments.
* Has a reliable caregiver able to accompany the participant to study visits and provide information for assessments.
* Willing to participate and sign informed consent.
Exclusion Criteria:
* 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.
* Significant active physical illness, including severe cardiac disease, severe systemic infection, or severe liver/kidney dysfunction.
* Elevated tumor markers or tumor history.
* Immune-related disease.
* Significant nasal obstruction.
* Serious suicide risk.
* Participation in another clinical trial or stem cell therapy within the past 6 months.
* Any other condition judged inappropriate by the investigator.
* Contraindications to MRI or inability to complete MRI examinations, including non-MRI-compatible metallic implants, certain stents, plates, pacemakers, or severe claustrophobia.

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2026-05-15