NCT07554872Not yet recruitingPhase 1
Study of Neural Stem Cell-Derived Exosomes in Moderate-to-Severe Early-Onset Alzheimer's Disease
A Phase I, Open-Label, Single-Center, Frequency-Escalation Study of the Safety, Tolerability, and Preliminary Efficacy of Neural Stem Cell-Derived Exosomes in Patients With Moderate-to-Severe Early-Onset Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (estimated)
- First submitted
- 21 Apr 2026
- Start date
- May 2026
- Primary completion date
- 20 Oct 2027
- Lead sponsor
- Shanghai Mental Health Center
- Diseases
- Alzheimer disease
- NCT number
- NCT07554872
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 9
- From May 2026 to the primary completion date, 20 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another clinical trial or stem cell therapy within the past 6 months.
- Contraindications to MRI or inability to complete MRI examinations, including non-MRI-compatible metallic implants, certain stents, plates, pacemakers, or severe claustrophobia.
Other illness
- 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.
- Immune-related disease.
- Any other condition judged inappropriate by the investigator.
Other
- Elevated tumor markers or tumor history.
- Significant nasal obstruction.
- Serious suicide risk.
Criteria the registry did not label
- 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.
Age in the registry: 50 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Mental Health Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.