The Effect of CB-Exo-A600 in Mild to Moderate Alzheimer's Disease
ConditionMild to Moderate Alzheimer's Disease
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorXuanwu Hospital, Beijing
About this trial
This study is divided into two phases: a dose-escalation phase and an expansion cohort phase. The dose-escalation phase is a single-center study, while the expansion cohort phase is a multicenter, prospective, randomized, double-blind, placebo-controlled study.
Eligibility criteria
Qualifiers
Age ≥ 50 years, male or female.
Clinical diagnosis of AD (mild to moderate stage, corresponding to clinical stage 4-5 at screening according to the 2024 National Institute on Aging/Alzheimer's Association [NIA/AA] criteria).
Patients with cerebrospinal fluid biomarker data supporting an AD diagnosis within the past 3 years, or a positive amyloid Positron Emission Tomography (PET) scan result within the past 3 years, or a plasma p-tau217 test result indicating brain amyloid positivity.
Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan performed within 6 months prior to screening shows findings consistent with the clinical diagnosis of mild to moderate AD and no other clinically significant comorbid pathologies, particularly cerebrovascular disease. If an MRI or CT scan is not available within the 6 months prior to screening, an MRI must be completed and results confirmed before the subject initiates treatment.
Disqualifiers
Patients with a known allergic reaction to the investigational drug or similar drugs.
Patients with a known allergic constitution.
Previous receipt of umbilical cord mesenchymal stem cell therapy.
Laboratory findings (any of the following): absolute neutrophil count < 1.0 × 10⁹/L, platelet count < 100 × 10⁹/L, serum creatinine > upper limit of normal range, serum total bilirubin, alanine aminotransferase, or aspartate aminotransferase > 2 × upper limit of normal range.
Trial design
Treatments tested in this trial
- Exosomes derived from umbilical cord mesenchymal stem cell for intranasal drop
- A placebo of exosomes derived from umbilical cord mesenchymal stem cell for intranasal drop
Treatment groups
33 Participants
are divided into 2 treatment groupsSponsors and collaborators
Xuanwu Hospital, Beijing
Lead sponsor
Carrier Biomed (Suzhou) Co., Ltd
Collaborator
Institute of Process Engineering, Chinese Academy of Sciences
Collaborator
Source ClinicalTrials.gov