NCT06010511 WHIte MAtter Hyperintensity Shape and Glymphatics
| NCT ID | NCT06010511 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Leiden University Medical Center |
| Condition | Cerebral Small Vessel Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2023-01-18 |
| Primary Completion | 2026-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2023-01-18 with a primary completion date of 2026-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In a society with increased life expectancy, the economic, social and personal burden of dementia increases. Dementia is often caused by a combination of neurovascular and neurodegenerative diseases. Impaired brain clearance is suggested to be closely related to dementia development, as waste products (e.g. amyloid beta) accumulate in the brain, leading to neurodegeneration. Cerebral small vessel disease (SVD) is the most common neurovascular disease that even contributes to about 45% of dementia pathophysiology in patients with a diagnosis of Alzheimer's dementia. White matter hyperintensities of presumed vascular origin (WMH) are the key brain MRI manifestation of cerebral SVD. There is evidence that the currently known and MRI-visible WMH are landmarks of an already progressed stage of the underlying pathology. The pathophysiology of WMH has been attributed to multiple underlying mechanisms, such as hypoperfusion, defective cerebrovascular reactivity and blood-brain barrier dysfunction. Furthermore, different anatomical locations and different types of WMH are related to different underlying pathological changes. Using ultra-high field 7T MR imaging techniques WMH lesions can be detected with a higher sensitivity and resolution than on 3T MRI. The hypothesis is that different pathological mechanisms of cerebral SVD lead to variations in WMH shape. Moreover, the brain clearance ('glymphatic') system of the brain appears to be tightly connected to dementia pathology. Thus, novel markers of glymphatic activity could aid to describe and understand the pathology.
Eligibility Criteria
Inclusion Criteria: * Admitted to the memory or the geriatric clinic of the LUMC, the Alrijne Hospital Leiden or the Haga Hospital the Hague * From 65 years of age * Eligible for MRI * Native-level Dutch speaker Exclusion Criteria: * Claustrophobia * Contraindications for MRI such as metal implants and pacemaker * Use of benzodiazepines * Initiated treatment with antidepressants less than 6 weeks prior to inclusion * Not being able to provide written informed consent (assessed by the treating physician) * Individuals that have been declared mentally incapacitated * Other severe neurological disease besides dementia related * Cognitive impairment due to known other neurological disease * Previous brain surgery
Contact & Investigator
Jeroen de Bresser, MD, PhD
PRINCIPAL INVESTIGATOR
Leiden University Medical Center
Frequently Asked Questions
Who can join the NCT06010511 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Cerebral Small Vessel Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06010511 currently recruiting?
Yes, NCT06010511 is actively recruiting participants. Contact the research team at i.eiling@lumc.nl for enrollment information.
Where is the NCT06010511 trial being conducted?
This trial is being conducted at Leiden, Netherlands.
Who is sponsoring the NCT06010511 clinical trial?
NCT06010511 is sponsored by Leiden University Medical Center. The principal investigator is Jeroen de Bresser, MD, PhD at Leiden University Medical Center. The trial plans to enroll 50 participants.