Can a nasal spray of stem cell 'Messages' slow Alzheimer's?
NCT ID NCT07457125
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial is testing whether a nasal spray containing exosomes from umbilical cord stem cells is safe and might help people with mild to moderate Alzheimer's. The study involves 33 participants and will first test different doses, then compare the best dose to a placebo. The main focus is on safety, but researchers will also check if it affects memory and thinking.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- exosomes derived from umbilical cord mesenchymal stem cells (CB-Exo-A600) given as a nasal spray
- What this could lead to
- If it works, this could point toward a new way to slow or manage Alzheimer's symptoms using stem cell-derived exosomes delivered through the nose.
- What could go wrong
- This is an early Phase 1/2 trial with only 33 participants, so it is too small to prove effectiveness. The main goal is safety, and it is unknown if the treatment will actually help memory or thinking.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 33 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Any other condition deemed by the investigator to make the subject unsuitable for participation or that may pose a significant risk to the patient.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Xuanwu Hospital, Capital Medical University
RECRUITINGBeijing, 100053, China
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