Alzheimer Disease (AD)CogniGuardNCT06620640
A Study Evaluating the Efficiency and Safety for the VGuard Device in Alzheimer's Disease.
A study testing Intervention will most probably modify activity of neuron networks in specific brain areas responsible for cognitive functions, especially memory consolidation. in people with Alzheimer Disease (AD), run by Neuromedical Sp. z o.o. at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Alzheimer Disease (AD)
- What is being tested?
- Intervention will most probably modify activity of neuron networks in specific brain areas responsible for cognitive functions, especially memory consolidation.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 sitePoland
- Study dates
- 21 Jan 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Permanent usage of benzodiazepines or cholinergic drugs.
- Insomnia
- 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.
- A serious communication barrier.
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Adult Psychiatry Medical University of Lodz
Lodz, Łódź Voivodeship, 91-229
About this study
Official title: 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.
- Conditions
- Alzheimer Disease (AD)
- Being tested
- Intervention will most probably modify activity of neuron networks in specific brain areas responsible for cognitive functions, especially memory consolidation.
- Keywords
- Alzheimer Disease (AD)
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention will most probably modify activity of neuron networks in specific brain areas responsible for cognitive functions, especially memory consolidation.Device
Nigth stimulation
| Study group | Role | What they receive |
|---|---|---|
| ARM A: Active VGuard device | Experimental | Active VGuard device Receives: 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 Receives: Device: Intervention will most probably modify activity of neuron networks in specific brain areas responsible for cognitive functions, especially memory consolidation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 24 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start21 Jan 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuromedical Sp. z o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620640
- Sponsor's protocol ID
- VGuard- MCI- AD- 2020
- Acronym
- CogniGuard
- Status last verified
- Sep 2024
- First submitted
- 26 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Experimental Study Evaluating the Efficiency and Safety for the VGuard Device in the Treatment of Alzheimer's Disease.
- ClinicalTrials.gov ID
- NCT06620640
- Acronym / sponsor ID
- CogniGuard / VGuard- MCI- AD- 2020
- Conditions
- Alzheimer Disease (AD)
- Keywords
- Alzheimer Disease (AD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Neuromedical Sp. z o.o.Industry (pharma, biotech, devices)
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM A: Active VGuard device | Experimental | Device: Intervention will most probably modify activity of neuron networks in specific brain areas responsible for cognitive functions, especially memory consolidation.Active VGuard device |
| ARM B: Sham VGuard device | Sham comparator | Device: Intervention will most probably modify activity of neuron networks in specific brain areas responsible for cognitive functions, especially memory consolidation.Sham VGuard device |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention will most probably modify activity of neuron networks in specific brain areas responsible for cognitive functions, especially memory consolidation.Nigth stimulation | Device | ARM A: Active VGuard device, ARM B: Sham VGuard device |
Primary outcome
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.
2 secondary outcomes
Secondary efficacy cognitive variable
Time frame: up to 24 weeks
Secondary efficacy affective and behavioral variables
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention will most probably modify activity of neuron networks in specific brain areas responsible for cognitive functions, especially memory consolidation. in people with Alzheimer Disease (AD), run by Neuromedical Sp. z o.o. at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary efficacy: proportion of patients responding to treatment with VGuard (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024; AzTrials last refreshed its copy on 29 Oct 2026.