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

StatusNot Yet Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Eligibility criteria revised
    • Secondary endpoints: details revised at 1 of 8 entries
    v4
  2. Re-verified, no change to tracked fieldsv3
  3. Secondary endpoints: details revised at 8 of 8 entriesv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07554872
Lead Sponsor Shanghai Mental Health Center
Collaborators: Shanghai Angecon Biotechnology Co., Ltd.
Conditions
(from sponsor)		 Alzheimer Disease (AD)
Related terms Alzheimer Disease
Enrollment 9 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov