Study of Neural Stem Cell-Derived Exosomes in Moderate-to-Severe Early-Onset Alzheimer's Disease (NCT07554872) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Study of Neural Stem Cell-Derived Exosomes in Moderate-to-Severe Early-Onset Alzheimer's Disease
China9 participantsStarted 2026-05
Plain-language summary
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.
Who can participate
Age range50 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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 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 psych…
What they're measuring
1
Number of Participants With Treatment-Related Adverse Events
Timeframe: Baseline to Week 4
2
Number of Participants With Treatment-Related Clinical Laboratory Abnormalities