Mild to Moderate Alzheimer's DiseasePhase 1/2CB-EXOADNCT07457125
The Effect of CB-Exo-A600 in Mild to Moderate Alzheimer's Disease
A Phase 1/2 study testing Exosomes derived from umbilical cord mesenchymal stem cell for intranasal drop in people with Mild to Moderate Alzheimer's Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild to Moderate Alzheimer's Disease
- What is being tested?
- Exosomes derived from umbilical cord mesenchymal stem cell for intranasal drop
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2026to 30 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
- Any other condition deemed by the investigator to make the subject unsuitable for participation or that may pose a significant risk to the patient.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, 100053
Gaoting Ma, 010 8319 8277, demo_doctor@163.com
About this study
Official title: The Safety and Preliminary Efficacy of Exosomes Derived From Umbilical Cord Mesenchymal Stem Cell (CB-Exo-A600) in Mild to Moderate Alzheimer's Disease
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.
Read the detailed description
Dose-Escalation Phase:
A traditional "3+3" dose-escalation design will be used. Subjects will be sequentially assigned to one of three dose groups (0.75 × 10¹⁰ Particles/mL, 1.50 × 10¹⁰ Particles/mL, 3.00 × 10¹⁰ Particles/mL; 1 mL per nostril, total dose volume of 2 mL per administration, twice weekly with an interval of 3±1 days between doses, for 12 weeks). Three subjects will be enrolled in each dose group. Escalation to the next dose level will proceed if no Dose-Limiting Toxicity (DLT) is observed in these 3 subjects. If 1 out of 3 subjects experiences a DLT, an additional 3 subjects will be enrolled in the same dose group. Escalation to the next dose level will proceed if no DLT is observed in these additional 3 subjects.
Expansion Cohort Phase:
24 subjects will be randomized in a 1:1 ratio to either the experimental group (exosome group) or the control group (exosome mimetic group). The dose for the experimental group in this phase will be determined by the Safety Review Committee based on the safety and efficacy data from the dose-escalation phase. The dosing frequency and duration will be 1 mL per nostril, total dose volume of 2 mL per administration, twice weekly with an interval of 3±1 days between doses, for 12 weeks.
- Conditions
- Mild to Moderate Alzheimer's Disease
- Being tested
- 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
- Keywords
- Exosomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exosomes derived from umbilical cord mesenchymal stem cell for intranasal dropDrug
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.
A placebo of exosomes derived from umbilical cord mesenchymal stem cell for intranasal dropDrug
Specification: 2.0 mL/vial.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: A placebo of exosomes derived from umbilical cord mesenchymal stem cell for intranasal drop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious adverse events
The proportion of patients who experienced severe adverse events.
Measured: 24 weeks (±1 week)
Secondary outcomes (11)
Alzheimer's Disease Assessment Scale-cog
Change from baseline in the Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-cog) score
Measured: 24 weeks (±1 week）
Incidence of adverse events
The proportion of patients who experienced adverse events.
Measured: 24 weeks (±1 week)
Incidence of severe adverse events
The proportion of patients who experienced severe adverse events.
Measured: 12 weeks (±1 week)
Incidence of adverse events
The proportion of patients who experienced adverse events.
Measured: 12 weeks (±1 week)
Incidence of severe adverse events
The proportion of patients who experienced severe adverse events.
Measured: 4 weeks (±3 days)
Incidence of adverse events
The proportion of patients who experienced adverse events.
Measured: 4 weeks (±3 days)
Alzheimer's disease assessment scale-cognitive section（ADAS-cog）
Change from baseline in ADAS-cog score
Measured: 12 weeks (±1 week)
Mini-Mental State Examination (MMSE)
Change from baseline in Mini-Mental State Examination (MMSE) score
Measured: 24 weeks (±1 week)
Montreal Cognitive Assessment (MoCA)
Change from baseline in Montreal Cognitive Assessment (MoCA) score
Measured: 24 weeks (±1 week)
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) score
Measured: 24 weeks (±1 week)
Neuropsychiatric Inventory (NPI)
Change from baseline in Neuropsychiatric Inventory (NPI) score
Measured: 24 weeks (±1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start30 May 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Carrier Biomed (Suzhou) Co., Ltd, Chinese Academy of Sciences
- Responsible party
- Principal investigator, Junwei Hao, MD, Xuanwu Hospital, Beijing
- Investigators
- Junwei Hao, MD; PhD, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457125
- Sponsor's protocol ID
- X-MEC-2026-001
- Acronym
- CB-EXOAD
- Status last verified
- May 2026
- First submitted
- 2 Mar 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study will not share individual participant data to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Preliminary Efficacy of Exosomes Derived From Umbilical Cord Mesenchymal Stem Cell (CB-Exo-A600) in Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07457125
- Acronym / sponsor ID
- CB-EXOAD / X-MEC-2026-001
- Conditions
- Mild to Moderate Alzheimer's Disease
- Keywords
- Exosomes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Carrier Biomed (Suzhou) Co., Ltd, Chinese Academy of Sciences
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Dose-Escalation Phase:
A traditional "3+3" dose-escalation design will be used. Subjects will be sequentially assigned to one of three dose groups (0.75 × 10¹⁰ Particles/mL, 1.50 × 10¹⁰ Particles/mL, 3.00 × 10¹⁰ Particles/mL; 1 mL per nostril, total dose volume of 2 mL per administration, twice weekly with an interval of 3±1 days between doses, for 12 weeks). Three subjects will be enrolled in each dose group. Escalation to the next dose level will proceed if no Dose-Limiting Toxicity (DLT) is observed in these 3 subjects. If 1 out of 3 subjects experiences a DLT, an additional 3 subjects will be enrolled in the same dose group. Escalation to the next dose level will proceed if no DLT is observed in these additional 3 subjects.
Expansion Cohort Phase:
24 subjects will be randomized in a 1:1 ratio to either the experimental group (exosome group) or the control group (exosome mimetic group). The dose for the experimental group in this phase will be determined by the Safety Review Committee based on the safety and efficacy data from the dose-escalation phase. The dosing frequency and duration will be 1 mL per nostril, total dose volume of 2 mL per administration, twice weekly with an interval of 3±1 days between doses, for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exosomes group | Experimental | Drug: Exosomes derived from umbilical cord mesenchymal stem cell for intranasal dropPatients in this group will receive intranasal drops of exosomes derived from umbilical cord mesenchymal stem cells, twice weekly for 12 weeks. |
| Exosomes placebo group | Placebo comparator | Drug: A placebo of exosomes derived from umbilical cord mesenchymal stem cell for intranasal dropPatients in this group will receive a placebo intranasal drops of exosomes derived from umbilical cord mesenchymal stem cells, twice weekly for 12 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exosomes derived from umbilical cord mesenchymal stem cell for intranasal dropSpecification: 2.0 mL/vial. Particle concentration: (Low) 0.75 × 10¹⁰ Particles/mL, (Medium) 1.50 × 10¹⁰ Particles/mL, (High) 3.00 × 10¹⁰ Particles/mL. | Drug | Exosomes group |
| A placebo of exosomes derived from umbilical cord mesenchymal stem cell for intranasal dropSpecification: 2.0 mL/vial. | Drug | Exosomes placebo group |
Primary outcome
Incidence of serious adverse events
Time frame: 24 weeks (±1 week)
The proportion of patients who experienced severe adverse events.
11 secondary outcomes
Alzheimer's Disease Assessment Scale-cog
Time frame: 24 weeks (±1 week）
Incidence of adverse events
Time frame: 24 weeks (±1 week)
Incidence of severe adverse events
Time frame: 12 weeks (±1 week)
Incidence of adverse events
Time frame: 12 weeks (±1 week)
Incidence of severe adverse events
Time frame: 4 weeks (±3 days)
Incidence of adverse events
Time frame: 4 weeks (±3 days)
Alzheimer's disease assessment scale-cognitive section（ADAS-cog）
Time frame: 12 weeks (±1 week)
Mini-Mental State Examination (MMSE)
Time frame: 24 weeks (±1 week)
Montreal Cognitive Assessment (MoCA)
Time frame: 24 weeks (±1 week)
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Time frame: 24 weeks (±1 week)
Neuropsychiatric Inventory (NPI)
Time frame: 24 weeks (±1 week)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No. The study will not share individual participant data to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Junwei Hao, MD; PhD principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Exosomes derived from umbilical cord mesenchymal stem cell for intranasal drop in people with Mild to Moderate Alzheimer's Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junwei Hao, MD; PhD (010 8319 8277, haojunwei@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of serious adverse events (time frame: 24 weeks (±1 week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.