The Effect of CB-Exo-A600 in Mild to Moderate Alzheimer's Disease

NCT07457125 | Recruiting Phase 1

• 1 other identifier: X-MEC-2026-001
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild to Moderate Alzheimer's Disease

Keywords

Exosomes

Outcome Measures

Primary Outcomes (1)

• Incidence of serious adverse events

  The proportion of patients who experienced severe adverse events.

  24 weeks (±1 week)

Secondary Outcomes (11)

• Alzheimer's Disease Assessment Scale-cog

  24 weeks (±1 week）

• Incidence of adverse events

  24 weeks (±1 week)

• Incidence of severe adverse events

  12 weeks (±1 week)

• Incidence of adverse events

  12 weeks (±1 week)

• Incidence of severe adverse events

  4 weeks (±3 days)

Other Outcomes (6)

• AD biomarkers

  12 weeks (±1 week)

• AD biomarkers

  24 weeks (±1 week)

• Proteomics and RNA sequencing molecular profiles

  12 weeks (±1 week)

Study Arms (2)

Exosomes group

EXPERIMENTAL

Patients in this group will receive intranasal drops of exosomes derived from umbilical cord mesenchymal stem cells, twice weekly for 12 weeks.

Drug: Exosomes derived from umbilical cord mesenchymal stem cell for intranasal drop

Exosomes placebo group

PLACEBO COMPARATOR

Patients in this group will receive a placebo intranasal drops of exosomes derived from umbilical cord mesenchymal stem cells, twice weekly for 12 weeks.

Drug: A placebo of exosomes derived from umbilical cord mesenchymal stem cell for intranasal drop

Interventions

Exosomes derived from umbilical cord mesenchymal stem cell for intranasal drop DRUG

Specification: 2.0 mL/vial. Particle concentration: (Low) 0.75 × 10¹⁰ Particles/mL, (Medium) 1.50 × 10¹⁰ Particles/mL, (High) 3.00 × 10¹⁰ Particles/mL.

Exosomes group

A placebo of exosomes derived from umbilical cord mesenchymal stem cell for intranasal drop DRUG

Specification: 2.0 mL/vial.

Exosomes placebo group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Modified Hachinski Ischemic Score (mHIS) ≤ 4.
• Mini-Mental Status Examination (MMSE) score between 10 and 24 (inclusive).
• The subject has a clearly identified and reliable caregiver who meets the following criteria: able to independently read and understand relevant study documents at the study site and communicate necessary information with the investigator; willing to comply with clinical study procedures and ensure the provision of accurate information regarding the subject's status throughout the study; resides with the subject or provides care for the subject for no less than 2 hours per day on at least 3 days per week.
• Female subjects of childbearing potential (including women of reproductive age and those less than 1 year postmenopausal) must use effective contraceptive methods throughout the study.
• Patients have been on stable doses of cholinesterase inhibitors (e.g., donepezil, rivastigmine, galantamine, huperzine A), excitatory amino acid receptor antagonists (e.g., memantine), or other cognitive-enhancing medications (e.g., sodium oligomannate) for at least 60 days prior to enrollment and must continue on the same doses throughout the study period.
• The subject or their legal guardian voluntarily signs a written informed consent form and is able to comply with the study requirements for dosing and follow-up.

You may not qualify if:

• 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.
• Contraindications for MRI, including but not limited to: presence of cardiac pacemaker, defibrillator, cardiac stent, artificial heart valve, post-aneurysm surgery metal clips, implanted drug infusion device, any implanted electronic device (nerve stimulator, bone growth stimulator), intravascular embolization coils, filters, ECG monitor, metal sutures, shrapnel or buckshot, fracture fixation hardware, cochlear implant, middle ear implant, intraocular metallic foreign body, etc.
• Subject has Parkinson's disease, multiple cerebral infarction, vascular dementia, Huntington's disease, hydrocephalus, progressive supranuclear palsy, multiple sclerosis, epilepsy, intellectual disability, or a history of significant traumatic brain injury (with or without persistent neurological deficits) or known structural brain abnormalities.
• Serious systemic infection within 3 months prior to the screening period.
• Positive for Hepatitis B surface antigen, e antigen, or e antibody, or positive for Hepatitis B core antibody with detectable Hepatitis B virus DNA; positive for Hepatitis C virus antibody; positive for syphilis serology; or positive for Human Immunodeficiency Virus antibody.
• History of alcohol abuse, drug abuse, or psychiatric illness within 10 years prior to screening.
• History of malignant tumors.
• Uncontrolled or poorly controlled cardiovascular, cerebrovascular, hepatic, renal, pulmonary, endocrine or other systemic diseases.
• Presence of severe aphasia, auditory/visual impairment, unstable cardiac arrhythmia, or other severe conditions that would preclude completion of cognitive assessments or receipt of treatment.
• Any other severe, advanced, or end-stage disease with a life expectancy of less than 12 months.
• Known pregnancy or breastfeeding, or positive pregnancy test prior to randomization.
• Current participation in another interventional clinical study that may interfere with outcome assessments.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• Carrier Biomed (Suzhou) Co., Ltd: collaborator
• Institute of Process Engineering, Chinese Academy of Sciences: collaborator

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

RECRUITING

Study Officials

• Junwei Hao, MD; PhD

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Junwei Hao, MD; PhD

CONTACT

010 8319 8277; haojunwei@vip.163.com

Gaoting Ma, MD

CONTACT

010 8319 8277; demo_doctor@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Neurology Department

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 9, 2026
• Study Start: May 30, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)