A Study Evaluating the Efficiency and Safety for the VGuard Device in Alzheimer's Disease. (CogniGuard)

A Randomized, Double-blind, Experimental Study Evaluating the Efficiency and Safety for the VGuard Device in the Treatment of Alzheimer's Disease.

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease (AD)
• Intervention / Treatment: Device: Intervention will most probably modify activity of neuron networks in specific brain areas responsible for cognitive functions, especially memory consolidation.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Łódzkie
    • Łódź, Łódzkie, Poland, 91-229
      • Department of Adult Psychiatry Medical University of Lodz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Signed written informed consent prior to beginning study-related procedures.
2. Female and male subjects aged ≥ 60
3. Able to comply with the study protocol, in the investigator's judgment.

Exlusion Criteria:

1. Current or past history of: active psychosis, intellectual disability, bipolar disorder, alcohol abuse, addiction to psychoactive substances or any other major psychiatric condition.
2. 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.
3. Anticancer treatment within 12 months prior to the screening visit.

4. Clinically relevant serious co-morbid medical conditions within 3 months prior to the screening visit, including, but not limited to:

   1. current active or persistent infection
   2. clinically significant cardiac disease including unstable angina, acute myocardial infarction, congestive heart failure (NYHA III or NYHA IV), uncontrolled arrhythmia, uncontrolled hypertension (> 2nd stage),
   3. severe liver disease
   4. severe renal impairment
   5. uncontrolled diabetes
   6. chronic obstructive pulmonary disease (COPD)
   7. other metabolic, endocrine or systemic diseases affecting the central nervous system (present hypothyroidism), which in the physician's opinion may be the cause of dementia.
5. Permanent usage of benzodiazepines or cholinergic drugs.
6. Insomnia
7. Metal implants (excluding dental fillings) or devices such as pacemaker, medication pump, nerve stimulator, TENS unit, ventriculo-peritoneal shunt, cochlear implant, unless cleared by the study MD.
8. A serious communication barrier.
9. Clinically significant abnormalities at screening (Visit A) in laboratory tests, including: vitamin B12 deficiency or other laboratory abnormalities of possible clinical significance should be discussed with Principal Investigator to determine eligibility.

I 0. Positive pregnancy test ( for female of childbearing potential confirmed in medical interview) or is known from medical interview that woman is lactacting or pregnant.

11. Currently in a study of similar investigational device or investigational product which could interfere in study integrity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARM A: Active VGuard device; Active VGuard device	Device: Intervention will most probably modify activity of neuron networks in specific brain areas responsible for cognitive functions, especially memory consolidation.; Nigth stimulation
Sham Comparator: ARM B: Sham VGuard device; Sham VGuard device	Device: Intervention will most probably modify activity of neuron networks in specific brain areas responsible for cognitive functions, especially memory consolidation.; Nigth stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary efficacy: proportion of patients responding to treatment with VGuard	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.	up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary efficacy cognitive variable	The secondary efficacy endpoint is defined as the proportion of patients responding to treatment with VGuard as measured by using the median change in the: Color Trails Test (CTT); Verbal memory probing The scores from baseline between study arms. A responder is defined as a patient showing improvement or no decline in tests score from Visit C or E/F/G.* Responder rates will be evaluated separately for the listed above tests by independent raters.Visit F will be performed according to Investigator's discretion.	up to 24 weeks
Secondary efficacy affective and behavioral variables	Proportion of patients responding to treatment with VGuard between study arms. A responder is defined as a patient showing improvement or no decline in: Hamilton Depression Rating Scale, HORS;; Satisfaction With Life Scale (SWLS) assessed at the following time-points:; VisitC; Visit D; Visit E + End of Study; Additional (Visit F/G*)Visit F/G will be performed according to Investigator's discretion.	up to 24 weeks

Collaborators and Investigators

• Sponsor: Neuromedical Sp. z o.o.

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: September 26, 2024
• First Submitted That Met QC Criteria: September 27, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 27, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Alzheimer Disease (AD)
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: VGuard- MCI- AD- 2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No