BridgeMD
New treatment option for Mild to Moderate Alzheimer's Disease
Official title The Effect of CB-Exo-A600 in Mild to Moderate Alzheimer's Disease
ClinicalTrials.gov ID: NCT07457125
What this study is testing
What is Exosomes derived from umbilical cord mesenchymal stem cell for intranasal drop?
Exosomes derived from umbilical cord mesenchymal stem cell for intranasal drop is an investigational medicine, given as an once-weekly, being studied as a potential treatment for mild to moderate alzheimer's disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join 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...
- Patients with cerebrospinal fluid biomarker data supporting an AD diagnosis within the past 3 years, or a positive amyloid Positron Emission...
- Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan performed within 6 months prior to screening shows findings consistent with the...
- Modified Hachinski Ischemic Score (mHIS) ≤ 4.
You likely can't join 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 \ upper limit of normal range, serum total bilirubin, alanine aminotransferase...
- Contraindications for MRI, including but not limited to: presence of cardiac pacemaker, defibrillator, cardiac stent, artificial heart valve...
- Subject has Parkinson's disease, multiple cerebral infarction, vascular dementia, Huntington's disease, hydrocephalus, progressive supranuclear...
See the full eligibility 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...
- 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...
- 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...
- Female people 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...
- 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.
- 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 \ 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...
- 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...
- 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...
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.