Cerebral Small Vessel DiseasesWHIMASNCT06010511
WHIte MAtter Hyperintensity Shape and Glymphatics
An observational study of Cerebral Small Vessel Diseases and Dementia, Mixed, run by Leiden University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cerebral Small Vessel Diseases, Dementia, Mixed, Dementia, Vascular
- What is being tested?
- 3T MRI scan, 7T MRI scan and Neuropsychological assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Jan 2023to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: We will prospectively include patients with memory complaints and/or vascular brain abnormalities (n=50; over 65 years of age) from the memory clinic at one of their first visits, prior to any diagnosis, at the Leiden University Medical Center, the Alrijne Hospital Leiden or the Haga Hospital the Hague. If not enough eligible patients are available from the memory clinic, we will include participants from the geriatric clinic.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Other severe neurological disease besides dementia related
- Cognitive impairment due to known other neurological disease
- Previous brain surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, 2333ZA
Jasmin Annica Keller, MSc, 0031715265411, j.a.keller@lumc.nl
Jeroen de Bresser, MD, PhD, 0031715262052, J.H.J.M.de_Bresser@lumc.nl
About this study
Official title: White Matter Hyperintensity Shape and Glymphatics
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.
Read the detailed description
Aim:
The overall aim is to study how different pathological mechanisms in cerebral SVD influence WMH shape.
Primary objective:
To study the association of a more complex WMH shape with abnormalities in small vessel morphology.
Secondary objectives:
To study the association between WMH shape and cognition/other cerebral small vessel disease markers. To study the association of novel MRI markers of glymphatics with cerebral SVD markers and cognition.
Study design: Cross-sectional study that will be conducted at the Leiden University Medical Center (LUMC). Patients will be included from the LUMC or the Alrijne Hospital Leiden. The study contains 3T and 7T MRI scans, as well as neuropsychological assessments. The data will be analyzed by performing association analysis.
Study population: Patients of the memory/geriatric clinic that are over 65 years of age.
Main study parameter/endpoint: In order to postulate underlying mechanisms related to WMH shape variations the investigators will study the association between a more complex WMH shape and structural and functional markers of cerebral SVD (such as lacunes and microbleeds).
WMH shape is assessed as follows: Convexity, solidity, concavity index, and fractal dimension are calculated for periventricular/confluent WMH. A lower convexity and solidity, and higher concavity index and fractal dimension indicate a more irregular shape of periventricular/confluent WMH. For deep WMH, fractal dimension and eccentricity are determined. A higher eccentricity and fractal dimension indicate a more complex shape of deep WMH.
Other study parameters: The investigators want to investigate WMH shape parameters and the association with cognition (mini-mental state exam, clinical dementia rating and cognitive domain scores). Another endpoint is to investigate if different WMH phenotypes can be identified (by machine learning models). Moreover, the association between SVD markers/cognition and novel glymphatics markers (such as size of perivascular spaces, CSF mobility and 4th ventricle CSF flow dynamics) will be investigated.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The participants will not directly benefit from the results of the study. However, their contribution to the study will add important information about the pathophysiology of the cerebrovascular pathology that contributes to dementia. Therefore, it is not possible to study the research question in a different population group. The ultra-high field 7T MRI system is widely used in a research setting and since its first introduction in the 1990s no serious adverse events have been reported. Important temporary side-effects are vertigo, nausea and involuntary eye motion due to forces on ion currents in the semicircular loops. As all MRI scans are performed within a maximum of 60 minutes and without any contrast agents, the participant burden is seen as a non-substantial burden.
- Conditions
- Cerebral Small Vessel Diseases, Dementia, Mixed, Dementia, Vascular, Mild Cognitive Impairment, Cognitive Impairment, Cognitive Decline
- Being tested
- 3T MRI scan, 7T MRI scan, Neuropsychological assessment, General baseline data
- Keywords
- dementia, cerebral small vessel disease, White matter hyperintensities, cognitive impairment, cognitive decline, Glymphatics
- Medical subject headings
- Cerebral Small Vessel Diseases, Mixed Dementias, Dementia, Vascular, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3T MRI scanOther
Conventional (3T) brain MRI scans will be used to determine global and functional markers of cerebral SVD, like WMH volume and presence of lacunes, microbleeds and superficial siderosis (3D T1, 3D FLAIR, SWI, DWI), hemodynamics (arterial spin labelling \& flow territory mapping) and white matter structural integrity (diffusion tensor imaging (DTI)). Furthermore, we want to measure structural integrity with a novel MR fingerprinting sequence and an inhomogeneous magnetization transfer (ihMT) MRI scan. We also want to apply a fMRI scan technique to measure CSF fluctuations in the 4th ventricle as a measure of brain glymphatics. Also the flow-territory mapping sequence is a non-standard sequence. Heart rate and respiratory signal will be measured during the scans (3T and 7T MRI) with standard vendor-supplied equipment.
7T MRI scanOther
Ultra-high field (7T) brain MRI scans will be used to determine WMH shape and other markers of cerebral SVD in or surrounding the WMH, like local enlarged perivascular spaces, (cortical) microinfarcts and microbleeds (T1, T2, FLAIR and T2*) and vascular pulsatility (phase contrast MRI). Moreover, a recently implemented MRI technique to measure glymphatic flow in perivascular spaces will be used.
Neuropsychological assessmentBehavioural
- Mini-mental state examination
- Clock drawing
- 15-Word Verbal Learning Test, immediate and delayed
- Visual Association Test
- Stroop Color Word Test, 40 item version
- Trail Making Test A\&B
- Letter Digit Substitution Test
- Animal fluency test
- Hospital anxiety and depression scale
- Informant Questionnaire on Cognitive Decline in the Elderly
General baseline dataOther
Baseline data, such as age, sex, psychiatric comorbidity and medication lists will be extracted from the patient files.
Age (Year of birth); Years of education; BMI (height \& weight); Sex; Verhage scale (education); Smoking status; Blood values; Sleep habits; Waste-hip ratio; Blood pressure; Current/general cardiovascular health; Psychiatric comorbidity; medical history related to cardiovascular health.
| Study group | Role | What they receive |
|---|---|---|
| Memory clinic patients | We will prospectively include patients with memory complaints and/or vascular brain abnormalities (n=50; over 65 years of age) from the memory clinic (or geriatric clinic) at one of their first visits, prior to any diagnosis. Receives: Other: 3T MRI scan; Other: 7T MRI scan; Behavioral: Neuropsychological assessment; Other: General baseline data |
What is being measured
The primary outcome is the main question the study is designed to answer.
WMH shape
The investigators will use an in-house developed analysis pipeline to calculate WMH shape on 3T and 7T brain MRI scans. Associations between WMH shape and other SVD markers and cognition will be investigated with linear and logistic regression (at least corrected for age and sex).
Measured: at study visit during inclusion up to 3 years
Secondary outcomes (3)
Brain clearance
Measured on brain MRI as a marker of glymphatic activity.
Measured: at study visit during inclusion up to 3 years
Perivascular space volume
This marker will be measured on brain MRI.
Measured: at study visit during inclusion up to 3 years
WMH subtypes
Based on WMH parameters the investigators will study if subtypes of WMH can be identified.
Measured: at study visit during inclusion up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start18 Jan 2023
- Primary completion30 Aug 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cerebral Small Vessel DiseasesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer Nederland
- Responsible party
- Principal investigator, Jeroen de Bresser, Leiden University Medical Center
- Investigators
- Jeroen de Bresser, MD, PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010511
- Sponsor's protocol ID
- WHIMAS
- Acronym
- WHIMAS
- Status last verified
- Apr 2025
- First submitted
- 18 Jul 2023
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bos D, Wolters FJ, Darweesh SKL, Vernooij MW, de Wolf F, Ikram MA, Hofman A. Cerebral small vessel disease and the risk of dementia: A systematic review and meta-analysis of population-based evidence. Alzheimers Dement. 2018 Nov;14(11):1482-1492. doi: 10.1016/j.jalz.2018.04.007. Epub 2018 May 21.
PubMed 29792871Ghaznawi R, Geerlings MI, Jaarsma-Coes M, Hendrikse J, de Bresser J; UCC-Smart Study Group. Association of White Matter Hyperintensity Markers on MRI and Long-term Risk of Mortality and Ischemic Stroke: The SMART-MR Study. Neurology. 2021 Apr 27;96(17):e2172-e2183. doi: 10.1212/WNL.0000000000011827. Epub 2021 Mar 16.
PubMed 33727406Ghaznawi R, Geerlings MI, Jaarsma-Coes MG, Zwartbol MH, Kuijf HJ, van der Graaf Y, Witkamp TD, Hendrikse J, de Bresser J. The association between lacunes and white matter hyperintensity features on MRI: The SMART-MR study. J Cereb Blood Flow Metab. 2019 Dec;39(12):2486-2496. doi: 10.1177/0271678X18800463. Epub 2018 Sep 11.
PubMed 30204039Keller JA, Sigurdsson S, Klaassen K, Hirschler L, van Buchem MA, Launer LJ, van Osch MJP, Gudnason V, de Bresser J. White matter hyperintensity shape is associated with long-term dementia risk. Alzheimers Dement. 2023 Dec;19(12):5632-5641. doi: 10.1002/alz.13345. Epub 2023 Jun 12.
PubMed 37303267Kuhn-Keller JA, Eiling I, Hirschler L, Vaclavu L, Witjes-Ane MN, Wijngaarden M, Nagtegaal M, Ercan E, Rius Ottenheim N, van der Elst M, Sohl E, van Buchem MA, Mooijaart S, van Osch MJ, de Bresser J. The White Matter Hyperintensity Shape and Brain Clearance (WHIMAS) Study for Identification of Novel 7T Magnetic Resonance Imaging Markers of Cerebral Small Vessel Disease: Protocol for a Cross-Sectional Study. JMIR Res Protoc. 2025 Dec 4;14:e77681. doi: 10.2196/77681.
PubMed 41344663
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- White Matter Hyperintensity Shape and Glymphatics
- ClinicalTrials.gov ID
- NCT06010511
- Acronym / sponsor ID
- WHIMAS / WHIMAS
- Conditions
- Cerebral Small Vessel Diseases, Dementia, Mixed, Dementia, Vascular, Mild Cognitive Impairment, Cognitive Impairment, Cognitive Decline
- Keywords
- dementia, cerebral small vessel disease, White matter hyperintensities, cognitive impairment, cognitive decline, Glymphatics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Collaborators
- Alzheimer Nederland
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 24 Aug 2023 (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.
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.
Detailed description
Aim:
The overall aim is to study how different pathological mechanisms in cerebral SVD influence WMH shape.
Primary objective:
To study the association of a more complex WMH shape with abnormalities in small vessel morphology.
Secondary objectives:
To study the association between WMH shape and cognition/other cerebral small vessel disease markers. To study the association of novel MRI markers of glymphatics with cerebral SVD markers and cognition.
Study design: Cross-sectional study that will be conducted at the Leiden University Medical Center (LUMC). Patients will be included from the LUMC or the Alrijne Hospital Leiden. The study contains 3T and 7T MRI scans, as well as neuropsychological assessments. The data will be analyzed by performing association analysis.
Study population: Patients of the memory/geriatric clinic that are over 65 years of age.
Main study parameter/endpoint: In order to postulate underlying mechanisms related to WMH shape variations the investigators will study the association between a more complex WMH shape and structural and functional markers of cerebral SVD (such as lacunes and microbleeds).
WMH shape is assessed as follows: Convexity, solidity, concavity index, and fractal dimension are calculated for periventricular/confluent WMH. A lower convexity and solidity, and higher concavity index and fractal dimension indicate a more irregular shape of periventricular/confluent WMH. For deep WMH, fractal dimension and eccentricity are determined. A higher eccentricity and fractal dimension indicate a more complex shape of deep WMH.
Other study parameters: The investigators want to investigate WMH shape parameters and the association with cognition (mini-mental state exam, clinical dementia rating and cognitive domain scores). Another endpoint is to investigate if different WMH phenotypes can be identified (by machine learning models). Moreover, the association between SVD markers/cognition and novel glymphatics markers (such as size of perivascular spaces, CSF mobility and 4th ventricle CSF flow dynamics) will be investigated.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The participants will not directly benefit from the results of the study. However, their contribution to the study will add important information about the pathophysiology of the cerebrovascular pathology that contributes to dementia. Therefore, it is not possible to study the research question in a different population group. The ultra-high field 7T MRI system is widely used in a research setting and since its first introduction in the 1990s no serious adverse events have been reported. Important temporary side-effects are vertigo, nausea and involuntary eye motion due to forces on ion currents in the semicircular loops. As all MRI scans are performed within a maximum of 60 minutes and without any contrast agents, the participant burden is seen as a non-substantial burden.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Memory clinic patients | – | Other: 3T MRI scan, Other: 7T MRI scan, Behavioral: Neuropsychological assessment, Other: General baseline dataWe will prospectively include patients with memory complaints and/or vascular brain abnormalities (n=50; over 65 years of age) from the memory clinic (or geriatric clinic) at one of their first visits, prior to any diagnosis. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- We will prospectively include patients with memory complaints and/or vascular brain abnormalities (n=50; over 65 years of age) from the memory clinic at one of their first visits, prior to any diagnosis, at the Leiden University Medical Center, the Alrijne Hospital Leiden or the Haga Hospital the Hague. If not enough eligible patients are available from the memory clinic, we will include participants from the geriatric clinic.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
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 |
|---|---|---|
| 3T MRI scanConventional (3T) brain MRI scans will be used to determine global and functional markers of cerebral SVD, like WMH volume and presence of lacunes, microbleeds and superficial siderosis (3D T1, 3D FLAIR, SWI, DWI), hemodynamics (arterial spin labelling \& flow territory mapping) and white matter structural integrity (diffusion tensor imaging (DTI)). Furthermore, we want to measure structural integrity with a novel MR fingerprinting sequence and an inhomogeneous magnetization transfer (ihMT) MRI scan. We also want to apply a fMRI scan technique to measure CSF fluctuations in the 4th ventricle as a measure of brain glymphatics. Also the flow-territory mapping sequence is a non-standard sequence. Heart rate and respiratory signal will be measured during the scans (3T and 7T MRI) with standard vendor-supplied equipment. | Other | Memory clinic patients |
| 7T MRI scanUltra-high field (7T) brain MRI scans will be used to determine WMH shape and other markers of cerebral SVD in or surrounding the WMH, like local enlarged perivascular spaces, (cortical) microinfarcts and microbleeds (T1, T2, FLAIR and T2*) and vascular pulsatility (phase contrast MRI). Moreover, a recently implemented MRI technique to measure glymphatic flow in perivascular spaces will be used. | Other | Memory clinic patients |
| Neuropsychological assessment* Mini-mental state examination * Clock drawing * 15-Word Verbal Learning Test, immediate and delayed * Visual Association Test * Stroop Color Word Test, 40 item version * Trail Making Test A\&B * Letter Digit Substitution Test * Animal fluency test * Hospital anxiety and depression scale * Informant Questionnaire on Cognitive Decline in the Elderly | Behavioural | Memory clinic patients |
| General baseline dataBaseline data, such as age, sex, psychiatric comorbidity and medication lists will be extracted from the patient files. Age (Year of birth); Years of education; BMI (height \& weight); Sex; Verhage scale (education); Smoking status; Blood values; Sleep habits; Waste-hip ratio; Blood pressure; Current/general cardiovascular health; Psychiatric comorbidity; medical history related to cardiovascular health. | Other | Memory clinic patients |
Primary outcome
WMH shape
Time frame: at study visit during inclusion up to 3 years
The investigators will use an in-house developed analysis pipeline to calculate WMH shape on 3T and 7T brain MRI scans. Associations between WMH shape and other SVD markers and cognition will be investigated with linear and logistic regression (at least corrected for age and sex).
3 secondary outcomes
Brain clearance
Time frame: at study visit during inclusion up to 3 years
Perivascular space volume
Time frame: at study visit during inclusion up to 3 years
WMH subtypes
Time frame: at study visit during inclusion up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Background: PubMed 29792871Bos D, Wolters FJ, Darweesh SKL, Vernooij MW, de Wolf F, Ikram MA, Hofman A. Cerebral small vessel disease and the risk of dementia: A systematic review and meta-analysis of population-based evidence. Alzheimers Dement. 2018 Nov;14(11):1482-1492. doi: 10.1016/j.jalz.2018.04.007. Epub 2018 May 21.
- Background: PubMed 33727406Ghaznawi R, Geerlings MI, Jaarsma-Coes M, Hendrikse J, de Bresser J; UCC-Smart Study Group. Association of White Matter Hyperintensity Markers on MRI and Long-term Risk of Mortality and Ischemic Stroke: The SMART-MR Study. Neurology. 2021 Apr 27;96(17):e2172-e2183. doi: 10.1212/WNL.0000000000011827. Epub 2021 Mar 16.
- Background: PubMed 30204039Ghaznawi R, Geerlings MI, Jaarsma-Coes MG, Zwartbol MH, Kuijf HJ, van der Graaf Y, Witkamp TD, Hendrikse J, de Bresser J. The association between lacunes and white matter hyperintensity features on MRI: The SMART-MR study. J Cereb Blood Flow Metab. 2019 Dec;39(12):2486-2496. doi: 10.1177/0271678X18800463. Epub 2018 Sep 11.
- Background: PubMed 37303267Keller JA, Sigurdsson S, Klaassen K, Hirschler L, van Buchem MA, Launer LJ, van Osch MJP, Gudnason V, de Bresser J. White matter hyperintensity shape is associated with long-term dementia risk. Alzheimers Dement. 2023 Dec;19(12):5632-5641. doi: 10.1002/alz.13345. Epub 2023 Jun 12.
- Derived from this study: PubMed 41344663Kuhn-Keller JA, Eiling I, Hirschler L, Vaclavu L, Witjes-Ane MN, Wijngaarden M, Nagtegaal M, Ercan E, Rius Ottenheim N, van der Elst M, Sohl E, van Buchem MA, Mooijaart S, van Osch MJ, de Bresser J. The White Matter Hyperintensity Shape and Brain Clearance (WHIMAS) Study for Identification of Novel 7T Magnetic Resonance Imaging Markers of Cerebral Small Vessel Disease: Protocol for a Cross-Sectional Study. JMIR Res Protoc. 2025 Dec 4;14:e77681. doi: 10.2196/77681.
- Individual participant dataSharing planned: Undecided
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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.
Jeroen de Bresser, MD, PhD principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Small Vessel Diseases and Dementia, Mixed, run by Leiden University Medical Center at 1 site in Netherlands.
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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 13 Apr 2025. 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 Netherlands. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ingmar Eiling, MSc (0031715265411, i.eiling@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WMH shape (time frame: at study visit during inclusion up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06010511, which also lists 5 linked publications.
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 13 Apr 2025.