A Randomized, Double-blind, Experimental Study Evaluating the Efficiency and Safety for the VGuard Device in the Treatment of Alzheimer's Disease.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Alzheimer Disease (AD)
- Sponsor
- Neuromedical Sp. z o.o.
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- Primary efficacy: proportion of patients responding to treatment with VGuard
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The project will allow the assessment of the safety and clinical effectiveness of the device for the treatment of cognitive impairment at Alzheimer's diease. The technology used in this study is based on the vagal nerve stimulation method used for more than 25 years and approved by the FDA in the treatment of drug-resistant epilepsy, depression and migraine. The study will use a non-invasive device for percutaneous electrostimulation of the vagal nerve. The previous clinical experience described in the literature has shown that vagal nerve stimulation leads to the activation of brain areas responsible for processing and consolidation of the fresh memory, i.e. the memory being impaired in so-called Alzheimer's Disease -AD. In relation to currently used methods of cognitive disorders treatment such as pharmacotherapy, the new solution will increase the effectiveness of therapy. In addition, VGuard is a completely non-invasive device that uses percutaneous stimulation, safe for the patient, and stimulation ranges are below the threshold of perception.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed written informed consent prior to beginning study-related procedures.
- •Female and male subjects aged ≥ 60
- •Able to comply with the study protocol, in the investigator\'s judgment.
- •Exlusion Criteria:
- •Current or past history of: active psychosis, intellectual disability, bipolar disorder, alcohol abuse, addiction to psychoactive substances or any other major psychiatric condition.
- •Current or past history of any neurological disorder other than dementia, such as: epilepsy, stroke, Transient Ischemic Attack (TIA), Huntington\'s disease, Hakim syndrome, Parkinson\'s disease, multiple sclerosis, intracranial hematoma or brain lesions; and history of previous neurosurgery or head trauma that resulted in residual neurologic impairment.
- •Anticancer treatment within 12 months prior to the screening visit.
- •Clinically relevant serious co-morbid medical conditions within 3 months prior to the screening visit, including, but not limited to:
- •current active or persistent infection
- •clinically significant cardiac disease including unstable angina, acute myocardial infarction, congestive heart failure (NYHA III or NYHA IV), uncontrolled arrhythmia, uncontrolled hypertension (\> 2nd stage),
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Primary efficacy: proportion of patients responding to treatment with VGuard
Time Frame: up to 24 weeks
The primary efficacy endpoint is defined as the proportion of patients responding to treatment with VGuard as measured by using the median change in the: * Mini-Mental State Examination (MMSE) * ADAS-cog scores from baseline between study arms. A responder is defined as a patient showing improvement or no decline in MMSE score on or from Visit C or E/F/G\*. \*Visit F and G will be performed according to Investigator\'s discretion.
Secondary Outcomes
- Secondary efficacy cognitive variable(up to 24 weeks)
- Secondary efficacy affective and behavioral variables(up to 24 weeks)