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

NCT06620640 | Completed

• 1 other identifier: VGuard- MCI- AD- 2020
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease (AD)

Keywords

Alzheimer Disease (AD)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Secondary efficacy cognitive variable

  up to 24 weeks

• Secondary efficacy affective and behavioral variables

  up to 24 weeks

Study Arms (2)

ARM A: Active VGuard device

EXPERIMENTAL

Active VGuard device

Device: Intervention will most probably modify activity of neuron networks in specific brain areas responsible for cognitive functions, especially memory consolidation.

ARM B: Sham VGuard device

SHAM COMPARATOR

Sham VGuard device

Device: Intervention will most probably modify activity of neuron networks in specific brain areas responsible for cognitive functions, especially memory consolidation.

Interventions

Intervention will most probably modify activity of neuron networks in specific brain areas responsible for cognitive functions, especially memory consolidation. DEVICE

Nigth stimulation

ARM A: Active VGuard device; ARM B: Sham VGuard device

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),
• severe liver disease
• severe renal impairment
• uncontrolled diabetes
• chronic obstructive pulmonary disease (COPD)
• 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.

Sponsors & Collaborators

• Neuromedical Sp. z o.o.: lead

Study Sites (1)

Department of Adult Psychiatry Medical University of Lodz

Lodz, Łódź Voivodeship, 91-229, Poland

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: January 21, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

PL (1)