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

Not Yet RecruitingPhase 1

Sponsor: Shanghai Mental Health Center

Conditions: Alzheimer Disease (AD)

Interventions: Neural Stem Cell-Derived Exosomes

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 50 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (1)

Shanghai, Shanghai Municipality, China