Implantable Vagus Nerve Stimulation Modulation of Coeruleus-Norepinephrine Network for Mild-Moderate AD Patients
1 other identifier
interventional
6
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable alzheimer-disease
Started Nov 2022
Longer than P75 for not_applicable alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2022
CompletedFirst Posted
Study publicly available on registry
October 12, 2022
CompletedStudy Start
First participant enrolled
November 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
October 12, 2022
October 1, 2022
3.8 years
July 14, 2022
October 9, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
To evaluate the improvement of the cognitive state of AD patients
26 weeks
Secondary Outcomes (15)
Mini-mental state examination
26 weeks
Montreal cognitive assessment(MoCA)
26 weeks
Clinical dementia rating(CDR)
26 weeks
World Health Organization-University of California-Los Angeles Auditory Verbal Learning Test (WHO-UCLA AVLT)
26 weeks
Digit Span Test
26 weeks
- +10 more secondary outcomes
Study Arms (2)
Vagus nerve stimulation
EXPERIMENTALThe stimulator will be activated 2 weeks after the operation and continue for 24 weeks. The initial parameters of the program is set as: current 0.20mA, pulse width 500us, frequency 20Hz, stimulation time 30s, interval time 5min. A dynamic program control will be started at a speed of 0.20 mA, and the stimulation intensity will be controlled with the range of 0.4- 0.8mA.
Sham stimulation
SHAM COMPARATOR2 weeks after the operation, the stimulator will be turned off for 12 weeks. Then the stimulator will be turned on for 12 weeks. The initial parameters of the program is set as: current 0.20mA, pulse width 500us, frequency 20Hz, stimulation time 30s, interval time 5min. A dynamic program control will be started at a speed of 0.20 mA, and the stimulation intensity will be controlled with the range of 0.4- 0.8mA.
Interventions
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.
Eligibility Criteria
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 may not qualify 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xuanwu Hospital, Capital Medical University.
Beijing, 100053, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2022
First Posted
October 12, 2022
Study Start
November 1, 2022
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
October 12, 2022
Record last verified: 2022-10