A randomized controlled clinical study will be conducted in Xuanwu Hospital of Capital Medical University. This study initially explore the effect of selective vagus nerve(C fiber) stimulation on mild-to-moderate AD patients, in order to regulate the activity of the locus coeruleus-norepinephrine network, and to observe the improvement of cognitive function and memory function. We aim to evaluate the efficacy and safety of minimally invasive selective vagus nerve stimulation in the treatment of mild-to-moderate AD patients, to clarify the effective mechanism, and to provide an effective clinical treatment strategy.
This project plans to recruit 6 patients with Mild-Moderate Alzheimer's disease. They were randomly divided into vagus nerve active stimulation group and sham stimulation group, to receive vagus nerve stimulator implantation. 2 weeks after implantation, the active group will start the treatment for 12 weeks, and the stimulator of the shame group will be turned off for 12 weeks. Before treatment, cognitive assessment, head MRI and PET examination of norepinephrine distribution were completed. Side effects and adverse events were assessed at 6 weeks, 10 weeks, and 14 weeks, and cognitive assessment, head MRI and PET examination of norepinephrine distribution was also performed at the 14th week, Then, the true stimulation group continued to be turned on for 12 weeks, and the sham group turned on the stimulator to start the treatment for 12 weeks. cognitive assessment, head MRI and PET examination of norepinephrine distribution were also performed at 26 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
6
The implant surgery is performed under general anesthesia. The generator is implanted subcutaneously in the left upper chest or left axillary border. The electrode lead wire is attached to the left mid-cervical vagus nerve through a second incision in the left neck area. The lead wire is passed through a subcutaneous tunnel and attached to the pulse generator.
Xuanwu Hospital, Capital Medical University.
Beijing, China
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
To evaluate the improvement of the cognitive state of AD patients
Time frame: 26 weeks
Mini-mental state examination
To evaluate the improvement of the cognitive state of AD patients. The scale consists of 20 questions with a total of 30 items, involving five aspects of orientation, memory, attention and calculation, recall, and language. It can be used as a screening examination and evaluation method for patients with moderate or severe dementia.
Time frame: 26 weeks
Montreal cognitive assessment(MoCA)
To evaluate the improvement of the cognitive state of AD patients
Time frame: 26 weeks
Clinical dementia rating(CDR)
To evaluate the improvement of the cognitive state of AD patients
Time frame: 26 weeks
World Health Organization-University of California-Los Angeles Auditory Verbal Learning Test (WHO-UCLA AVLT)
To evaluate the improvement of the cognitive state of AD patients
Time frame: 26 weeks
Digit Span Test
To evaluate the improvement of the cognitive state of AD patients
Time frame: 26 weeks
Trail making test(TMT)
To evaluate the improvement of the cognitive state of AD patients
Time frame: 26 weeks
Boston naming test(BNT)
To evaluate the improvement of the cognitive state of AD patients
Time frame: 26 weeks
Clock-drawing test
To evaluate the improvement of the cognitive state of AD patients
Time frame: 26 weeks
Global Deterioration Scale(GDS)
To evaluate the improvement of the cognitive state of AD patients.The Global Deterioration Scale (GDS), developed by Dr. Barry Reisberg, provides caregivers an overview of the stages of cognitive function for those suffering from a primary degenerative dementia such as Alzheimer's disease. It is broken down into 7 different stages. Stages 1-3 are the pre-dementia stages. Stages 4-7 are the dementia stages. Biginning in stage 5, an individual can no longer survive without assistance.
Time frame: 26 weeks
Modified hachinski ischemic score
The modified Hachinski ischaemic scale is an attempt to differentiate Alzheimer's type dementia and multi-infarct dementia.A score of 2 or less are typical of a patient with Alzheimer's disease. A score of greater than 2 is typical of multi-infarct dementia.
Time frame: 26 weeks
Neuropsychiatric Inventory(NPI)
To assess the improvement of common behaviors associated with dementia
Time frame: 26 weeks
Sturcture MRI
To evaluate the morphologic change of locus coeruleus
Time frame: 26 weeks
Functional MRI and Diffussion Tensor Imaging
To evaluate the brain connectivity change
Time frame: 26 weeks
Event related potential measured by electroencephalogram
To evaluate the improvement of the working memory
Time frame: 26 weeks
The norepinephrine transporter PET(NET-PET)
To evaluate the change of norepinephrine distribution of the brain
Time frame: 26 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.