NCT05575271 · NOT YET RECRUITING
Implantable Vagus Nerve Stimulation Modulation of Coeruleus-Norepinephrine Network for Mild-Moderate AD Patients
This trial is testing whether a surgically implanted device that stimulates the vagus nerve can improve memory and thinking in people with mild-to-moderate Alzheimer's disease. The device targets a brain region called the locus coeruleus, which regulates a chemical called norepinephrine. Phase NA here means this is a controlled clinical study focused on evaluating effectiveness and safety, conducted in China. Details beyond the summary are limited.
You may qualify if
- Referring to the NIA-AA clinical AD diagnostic criteria formulated by 2011 National Institute on Aging (NIA) and Alzheimer's Disease Association (ADA) groups, select mild to moderate AD patients with positive amyloid PET;
- Male or female AD patients between the ages of 50-85;
- Neuropsychological evaluation reaches the following standards: MMSE 16-24 points, CDR 0.5-2 points;
- Patients who receives a stable cholinesterase inhibitor regimen continues the oral drug with the same dose for at least 8 weeks before entering the study
- The patient has sufficient proficiency in Mandarin Chinese and is able to complete the cognitive assessment form;
- Those who voluntarily accept the test and sign an informed consent form.
You're excluded if
- There is a clear history of cerebrovascular stroke, and there are clear symptoms or signs of neurological deficit at the time of onset, and there are corresponding responsible lesions left on neuroimaging;
- Those with a history of alcoholism, or drug addiction, or neurological diseases that can cause cognitive impairment, such as traumatic brain injury, epilepsy, encephalitis, normal intracranial pressure hydrocephalus;
- Suffering from systemic diseases that may lead to cognitive impairment (such as liver and kidney insufficiency, endocrine diseases, vitamin deficiency);
- Suffering from cardiac conductive dysfunction (bradycardia) or sleep apnea syndrome;
- Participating in other drug clinical trials;
- There are contraindications to head MRI.
- Those who are deemed unsuitable to participate the trial by the investigator.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2022-10-12