BridgeMD
New treatment option for Alzheimer Disease (AD)
Official title Alzheimer's Disease Treated With Vagus Nerve Stimulation
ClinicalTrials.gov ID: NCT06923007
What this study is testing
- What it's testing
- The goal of this clinical trial is to evaluate the safety and efficacy of vagus nerve stimulation (VNS) for treating Alzheimer's disease (AD) in patients aged 50-80 years with mild cognitive impairment to moderate Alzheimer's disease. The main questions it aims to answer are: Is the change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) score at 6 months post-randomization better in the VNS group compared to the sham stimulation group?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 80
You may be able to join if
- Age: 50-80 years
- people conform to the diagnostic criteria for AD established by the National Institute on Aging and the Alzheimer's Association [National Institution...
- There is mild to moderate cognitive impairment, and the clinical cognitive rating scale [Clinical Dementia Rating (CDR)] score is 0.5-2.
- Stable use of the drug for more than 1 month, and no plan to change the medication within 6 months after randomization
- The informed consent form is signed, and the patient complies with the requirements.
You likely can't join if
- Dementia caused by other reasons, including vascular dementia, central nervous system infections (such as AIDS, syphilis, etc.), Creutzfeldt-Jakob...
- The presence of a serious or unstable disease, including cardiovascular, liver, kidney, gastrointestinal, respiratory, endocrine, neurological...
- A history of cancer within 5 years, except for non-metastatic basal cell carcinoma and/or squamous cell carcinoma, cervical carcinoma in situ...
- The subject has been diagnosed with any primary mental disorder other than AD-related cognitive impairment. If the investigator deems that the...
- people who are judged by the investigator to have suicidal tendencies
- Illiteracy or insufficient education to complete the scale assessment
See the full eligibility criteria
Who can join
- Age: 50-80 years
- people conform to the diagnostic criteria for AD established by the National Institute on Aging and the Alzheimer's Association [National Institution Aging and Alzheimer's Association (NIA-AA)]
- There is mild to moderate cognitive impairment, and the clinical cognitive rating scale [Clinical Dementia Rating (CDR)] score is 0.5-2.
- Stable use of the drug for more than 1 month, and no plan to change the medication within 6 months after randomization
- The informed consent form is signed, and the patient complies with the requirements.
What rules you out
- Dementia caused by other reasons, including vascular dementia, central nervous system infections (such as AIDS, syphilis, etc.), Creutzfeldt-Jakob disease, Huntington's disease and Parkinson's disease, dementia with...
- The presence of a serious or unstable disease, including cardiovascular, liver, kidney, gastrointestinal, respiratory, endocrine, neurological (AD-derived cognitive impairment excluded), psychiatric, immune or blood...
- A history of cancer within 5 years, except for non-metastatic basal cell carcinoma and/or squamous cell carcinoma, cervical carcinoma in situ, non-progressive prostate cancer, or other cancers with low risk of...
- The subject has been diagnosed with any primary mental disorder other than AD-related cognitive impairment. If the investigator deems that the presence of this mental disorder or symptom may affect the interpretation of...
- people who are judged by the investigator to have suicidal tendencies
- Illiteracy or insufficient education to complete the scale assessment
- Having a history of alcohol or drug abuse (excluding smoking history) within 2 years prior to the screening visit
- A history of multiple or severe drug allergy, obvious atopic allergic constitution or severe hypersensitivity after treatment (including but not limited to severe polymorphic erythema, linear IgA dermatosis, toxic...
- Important abnormalities that may be clinically significant and harmful to the subject, affect the study, or suggest other evidence of etiology of dementia during screening, such as physical examination or neurological...
- Screening MRI results showing significant abnormalities suggest another potential cause of progressive cognitive impairment, or findings with clinical significance that may affect the participants ability to safely...
- Any MRI contraindications, including claustrophobia, or the presence of prohibited metal (ferromagnetic) implant/cardiac pacemakers
- There are contraindications for VNS surgery, such as left vagus nerve injury, severe infection at the surgical site, and severe heart, lung, liver, kidney or other system dysfunction that cannot tolerate general...
- Currently participating in other treatment clinical trials, or any other type of medical research that is considered scientifically or medically incompatible with this study
- Other reasons that hinder the completion of this study, such as lack of stable caregivers
- Female people who are pregnant or planning to become pregnant
- Research center staff members and/or their immediate family members directly related to this study. Immediate family members are spouses, parents, children, or siblings, whether biological or legally adopted relatives.
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 to 80 years. 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.