Evaluation of the Link Between Carotid Arterial Wall Viscosity and Major Neurocognitive Disorders

NCT07205003 | Recruiting

• 2 other identifiers: 2021/021/OB2021-A00291-40
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The mechanical behavior of conductance arteries is viscoelastic. While the elastic component has been extensively studied, the viscous component has often been neglected for methodological reasons and also because it was considered weak. Unlike a purely elastic solid, which exhibits instantaneous deformation/relaxation upon application/discontinuation of a force, a viscoelastic solid is characterized, from a mechanical point of view, by a delay between the application or discontinuation of the force and deformation. Thus, at the arterial level, the elasticity of the arterial wall allows the internal diameter to increase proportionally to the blood pressure during systole. The viscous component will induce a delay in diameter restoration, resulting in a larger diameter at each pressure level during the diastolic phase compared to the systolic phase. This results in a shift between the systolic and diastolic curves of the pressure-diameter relationship, creating a hysteresis loop. From a thermodynamic point of view, while a purely elastic material fully restores the energy stored during the loading phase, viscoelastic arteries will incompletely restore this energy. Thus, the surface of the hysteresis loop reflects the energy dissipated during each cardiac cycle (WV), and the area under the loading phase curve represents the energy stored by the arterial wall (WE) during the latter. Thus, arterial wall viscosity (APV) can be expressed either as the absolute value of WV or as a function of the stored energy (WV/WE). Physiologically, this energy loss is low. Its increase could be accompanied by excessive energy dissipation, leading to increased cardiac work and cardio-circulatory decoupling. Conversely, low parietal viscosity could lead to damage to peripheral organs by excessive transmission of pulsatile energy to the periphery due to lack of damping.

Conditions

Neurocognitive Disorders; Alzheimer's Disease

Keywords

carotid arterial wall viscosity

Outcome Measures

Primary Outcomes (2)

• Evaluation of the difference in relative arterial wall viscosity value of the common carotid artery of patients with vascular dementia compared to that of patients with Alzheimer's disease

  Carotid wall viscosity will be assessed using a method developed in the pharmacology department, involving simultaneous and continuous measurement by two operators of local pressure and diameter at the right and left carotid arteries, combining echotracking (Vevo 3100®) with applanation tonometry (Millar®). Three successive measurements will be performed. These measurements will establish the diameter-pressure relationship, and their analysis will allow calculation of wall viscosity by measuring the area under the curve of this relationship during the cardiac cycle. The primary outcome measure will be the difference in carotid arterial wall viscosity between the two groups of subjects; it will be studied by analysis of variance (ANOVA).

  enrollment visit

• Evaluation of the difference in relative arterial wall viscosity value of the common carotid artery of patients with vascular dementia compared to that of patients not presenting dementia

  Carotid wall viscosity will be assessed using a method developed in the pharmacology department, involving simultaneous and continuous measurement by two operators of local pressure and diameter at the right and left carotid arteries, combining echotracking (Vevo 3100®) with applanation tonometry (Millar®). Three successive measurements will be performed. These measurements will establish the diameter-pressure relationship, and their analysis will allow calculation of wall viscosity by measuring the area under the curve of this relationship during the cardiac cycle. The primary outcome measure will be the difference in carotid arterial wall viscosity between the two groups of subjects; it will be studied by analysis of variance (ANOVA).

  enrollment visit

Secondary Outcomes (9)

• Evaluation of the link between arterial parietal viscosity of the common carotid artery and the intensity of cerebral vascular

  enrollment visit

• Study of the link between arterial parietal viscosity of the common carotid artery and the severity of cognitive impairment (MMSE)

  enrollment visit

• Study of the link between arterial parietal viscosity of the common carotid artery and the severity of cognitive impairment (Gröber test)

  enrollment visit

• Study of the link between arterial parietal viscosity of the common carotid artery and the severity of cognitive impairment (verbal fluency)

  enrollment visit

• Study of the link between arterial parietal viscosity of the common carotid artery and the severity of cognitive impairment (cognitive performance score (BREF))

  enrollment visit

Interventions

Assessment of carotid wall viscosity in patients with vascular dementia DIAGNOSTIC_TEST

Carotid wall viscosity will be assessed by simultaneous and continuous measurement by 2 operators of local pressure and diameter at the level of the right and left carotids by coupling echotracking (Vevo 3100®) with applanation tonometry (Millar®). 3 successive measurements will be carried out. These measurements will establish the diameter-pressure relationship and its analysis will allow the calculation of wall viscosity by measuring the area under the curve of this relationship during the cardiac cycle.

Assessment of carotid wall viscosity in patients with Alzheimer's disease DIAGNOSTIC_TEST

Carotid wall viscosity will be assessed by simultaneous and continuous measurement by 2 operators of local pressure and diameter at the level of the right and left carotids by coupling echotracking (Vevo 3100®) with applanation tonometry (Millar®). 3 successive measurements will be carried out. These measurements will establish the diameter-pressure relationship and its analysis will allow the calculation of wall viscosity by measuring the area under the curve of this relationship during the cardiac cycle.

Assessment of carotid wall viscosity in patients not presenting dementia. DIAGNOSTIC_TEST

Carotid wall viscosity will be assessed by simultaneous and continuous measurement by 2 operators of local pressure and diameter at the level of the right and left carotids by coupling echotracking (Vevo 3100®) with applanation tonometry (Millar®). 3 successive measurements will be carried out. These measurements will establish the diameter-pressure relationship and its analysis will allow the calculation of wall viscosity by measuring the area under the curve of this relationship during the cardiac cycle.

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

140 sujets dont 55 sujets avec démence vasculaire et 55 avec une démence de type maladie d'Alzheimer et 30 avec plainte mnésique sans troubles neurocognitifs.

You may qualify if:

• Age over 70
• Memory consultation consultant (neurology or geriatrics)
• Brain MRI less than one year old or planned as part of the cognitive assessment performed.
• Patient diagnosed with Alzheimer's disease according to DSM-5 criteria or vascular dementia according to DSM-5 criteria, or presenting a memory complaint without evidence of a dementia-related condition.
• No objection from the patient or their caregiver.
• Patient covered by a health insurance plan

You may not qualify if:

• Known unilateral or bilateral carotid stenosis or history of carotid surgery
• Permanent CA/AF
• Patient presenting with confusion
• Known psychiatric illness (severe depression, psychosis, etc.)
• Non-vascular, non-Alzheimer's dementia (e.g., Lewy Body Dementia, Parkinsonian Dementia, Progressive Supranuclear Palsy)
• Refusal to participate
• MMS less than or equal to 10
• Contraindication to performing an MRI
• Any acute decompensated pathology
• Patient under guardianship or curatorship

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

University Rouen Hospital

Rouen, 76031, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

In this context, an additional 4 mL EDTA tube will be collected to evaluate Alzheimer's disease biomarkers. This sample will be centrifuged to obtain six 150 μL aliquots and one 1 mL aliquot, which will then be stored at -80°C. The SIMOA® technique will allow the following Alzheimer's markers to be measured: Aβ1-40 and 1-42, Tau (the 3 included in the Neurology 3-Plex A kit), phosphoTau 181 and 231.

MeSH Terms

Conditions

Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Frédéric FR ROCA, Doctor

CONTACT

02 32 88 05 39; Frederic.Roca@chu-rouen.fr

Philippe PC CHASSAGNE, Professor

CONTACT

02 32 88 05 39; Philippe.Chassagne@chu-rouen.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 3, 2025
• Study Start: February 15, 2022
• Primary Completion: March 18, 2026
• Study Completion (Estimated): September 18, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)