Investigating the relationship between white matter hyperintensity shape and brain clearance in dementia
White Matter Hyperintensity Shape and Glymphatics
Leiden University Medical Center · NCT06010511
This study is trying to see how the shape of certain brain changes in older adults with small vessel disease relates to their thinking skills and dementia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center (other) |
| Locations | 1 site (Leiden) |
| Trial ID | NCT06010511 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore how different pathological mechanisms in cerebral small vessel disease (SVD) influence the shape of white matter hyperintensities (WMH) in patients over 65 years old. Conducted at the Leiden University Medical Center and Alrijne Hospital, the study will utilize advanced 3T and 7T MRI scans alongside neuropsychological assessments to analyze the association between WMH shape and cognitive function, as well as other markers of cerebral SVD. The research seeks to better understand the underlying mechanisms of WMH shape variations and their implications for dementia development.
Who should consider this trial
Good fit: Ideal candidates are patients over 65 years old admitted to the memory or geriatric clinic who are eligible for MRI and speak Dutch at a native level.
Not a fit: Patients with severe neurological diseases unrelated to dementia or those unable to undergo MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of dementia mechanisms and lead to improved diagnostic and therapeutic strategies.
How similar studies have performed: While studies have explored aspects of cerebral small vessel disease and dementia, this specific approach focusing on WMH shape and glymphatic function is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leiden
- Leiden University Medical Center — Leiden, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Jeroen de Bresser, MD, PhD — Leiden University Medical Center
- Study coordinator: Ingmar Eiling, MSc
- Email: i.eiling@lumc.nl
- Phone: 0031715265411
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cerebral Small Vessel Diseases, Dementia, Mixed, Dementia, Vascular, Mild Cognitive Impairment, Cognitive Impairment, Cognitive Decline, dementia, cerebral small vessel disease