DementiaNCT06322121
Vascular Aspects in Dementia: Part 2
An observational study of Dementia, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
Cerebral amyloid angiopathy (CAA), a common cerebrovascular small vessel disease (SVD), is a frequently (98%) found co-morbidity at autopsy in patients with Alzheimer's disease (AD). Current in vivo hallmarks of CAA represent changes relatively late in the disease process and leaves CAA in AD often undetected. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- MRI
- How many people
- 120 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Sep 2023to Sep 2026
- 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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who attended a memory clinic and healthy controls
Who may be able to join
- For this study three different routes for inclusion exists. Inclusion criteria for each group separately are shown below.
- Participants who were included in our previous CASCADE study (P19.039).
- Capable of giving informed consent (see appendix)
- Patients who attended a memory clinic within one year ago
- Diagnosed with (mixed) probable AD
- Diagnosed as MCI
Show all 13Show fewer
- Diagnosed as SCI
- Age between 50-90 years
- Capable of giving informed consent (see appendix)
- Control subjects
- Healthy adults without memory complaints
- Age between 50 -90 years
- Capable of giving informed consent
Who cannot join
- Contra-indication to MRI scanning:
- Claustrophobia
- Pacemakers and defibrillators
- Nerve stimulators
- Intracranial clips
- Intraorbital or intraocular metallic fragments
Show all 17Show fewer
- Cochlear implants
- Ferromagnetic implants
- Hydrocephaluspump
- Intra-utrine device (not all types) Permanent make-up
- Tattoos above the shoulders (not all)
- Specific contraindications to fMRI
- Seizure within prior year.
- Noncorrectable visual impairment.
- MMSE < 19 points (measured at moment of screening or at memory clinic with a maximum of 6 months in retrospect)
- Severe physical restrictions (completely wheelchair dependent)
- Age above 90
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clarifying the Vascular Aspects of Dementia; Natural History Study
Cerebral amyloid angiopathy (CAA), a common cerebrovascular small vessel disease (SVD), is a frequently (98%) found co-morbidity at autopsy in patients with Alzheimer's disease (AD). Current in vivo hallmarks of CAA represent changes relatively late in the disease process and leaves CAA in AD often undetected. Recently, it was shown that decreased vascular reactivity (VR) measured with blood oxygen level dependent (BOLD) MRI, after visual stimulus, is an early CAA marker. With BOLD-MRI to detect decreased VR in different stages of AD, it was shown that increasing stages of AD associate with decreasing VR independent of age, classic SVD markers and atrophy. Moreover, VR is associated with cognitive deficits. Therefore, cross-sectional data indicate that decreased VR is an important co-morbidity already in early stages of AD with an independent effect on disease severity. In this respect, the study aim is to determine the natural course of the decrease of VR in both controls and (early stage) AD patients to monitor AD disease progression. This is an essential step to aid in the development and application of effective treatment as it is expected that CAA can cause/worsen AD pathology.
Read the detailed description
Rationale: Cerebral amyloid angiopathy (CAA), a common cerebrovascular small vessel disease (SVD), is a frequently (98%) found co-morbidity at autopsy in patients with Alzheimer's disease (AD). Current in vivo hallmarks of CAA represent changes relatively late in the disease process and leaves CAA in AD often undetected. Recently, it was shown that decreased vascular reactivity (VR) measured with blood oxygen level dependent (BOLD) MRI, after visual stimulus, is an early CAA marker. With BOLD-MRI to detect decreased VR in different stages of AD, it was shown that increasing stages of AD associate with decreasing VR independent of age, classic SVD markers and atrophy. Moreover, VR is associated with cognitive deficits. Therefore, cross-sectional data indicate that decreased VR is an important co-morbidity already in early stages of AD with an independent effect on disease severity. In this respect, the study aim is to determine the natural course of the decrease of VR in both controls and (early stage) AD patients to monitor AD disease progression. This is an essential step to aid in the development and application of effective treatment as it is expected that CAA can cause/worsen AD pathology.
Objective: To investigate longitudinal changes in VR in patients with subjective cognitive impairment (SCI), mild cognitive impairment (MCI) and AD dementia compared with controls. To investigate whether VR predicts progression of disease severity (cognitive decline) over a time period of 3 years and to investigate if decreased VR at baseline predicts increasing severity of other MRI markers for AD and SVD-markers at follow-up.
Study design: an longitudinal observational case - control study.
Study population: 30 AD patients, 30 patients with mild cognitive impairment and 30 patients with subjective cognitive impairment plus 30 controls, 50-90 yr old.
Main study parameters/endpoints: 1) 3T MRI: the amplitude of the BOLD response in percentage signal change between stimulus on and off, time-to-peak response (sec), and time-to-baseline (sec) after discontinuation of the visual stimulus, classic signs of CAA (intracranial hemorrhage, lobar microbleeds, subarachnoidal hemorrhage and superficial siderosis) and SVD markers (number of small subcortical infarcts and lacunes, volume of white matter hyperintensities (WMHs), perivascular spaces in the basal ganglia and centrum semiovale, number and location of deep microbleeds and grey matter volume). 2) Neuropsychological assessment 3) Baseline characteristics, 4) DNA: APOE ε genotype.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This is a non-therapeutic group relatedness study in only capacitated subjects. In order to achieve the aim of the study AD patients are needed. Vascular reactivity has potential to determine the role of the vascular aspects in AD. The risks of this research are minimal (risk of every day life), because there are no consequences to the health of the participant. We will keep the burden at a minimum. The research will consist of a 60 minutes MRI scan, a neuropsychological assessment of 1 hour and collection of 2 ml saliva (if not already collected at baseline).
- Conditions
- Dementia
- Being tested
- MRI
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
Assessment of vascular reactivity and CAA/SVD MRI markers
| Study group | Role | What they receive |
|---|---|---|
| Dementia patients | Patients with a dementia diagnosis; probable Alzheimer or mixed-type dementia Receives: Other: MRI | |
| MCI patients | Patients with a MCI diagnosis; patients demonstrating cognitive deficits on neuropsychological testing but not fulfilling the criteria for dementia. Receives: Other: MRI | |
| SCI patients | Patients not demonstrating cognitive deficits on neuropsychological testing are classified as SCI Receives: Other: MRI | |
| Controls | Control subject without cognitive complaints Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular reactivity - BOLD amplitude
The change in BOLD signal in response to visual stimulation as measured by the amplitude of the BOLD response in percentage signal change between stimulus on and off.
Measured: 1,5 - 2 years between time point 1 and time point 2
Vascular reactivity - time-to-peak
The time-to-peak response (sec) is defined as the duration from the beginning of visual stimulation to the peak response.
Measured: 1,5 - 2 years between time point 1 and time point 2
Vascular reactivity - time-to-baseline
The time-to-baseline response (sec) is defined as the duration from the end of the stimulus to baseline.
Measured: 1,5 - 2 years between time point 1 and time point 2
Secondary outcomes (9)
Intracranial hemorrhage
number
Measured: 1,5 - 2 years between time point 1 and time point 2
Lobar microbleeds
number
Measured: 1,5 - 2 years between time point 1 and time point 2
Subarachnoidal hemorrhage
number
Measured: 1,5 - 2 years between time point 1 and time point 2
Superficial siderosis
absent / focal / disseminated
Measured: 1,5 - 2 years between time point 1 and time point 2
Lacunes
number
Measured: 1,5 - 2 years between time point 1 and time point 2
Volume of white matter hyperintensities (WMHs)
cm3
Measured: 1,5 - 2 years between time point 1 and time point 2
Perivascular spaces in the basal ganglia
degree 1: <5 PVS degree 2: 5 - 10 PVS degree 3: >10 PVS (but still numerable) degree 4: an innumerable number of PVS
Measured: 1,5 - 2 years between time point 1 and time point 2
Perivascular spaces in the centrum semiovale
0= no PVS
- < 10 PVS
- 11-20 PVS
- 21-40 PVS
- >40 PVS
Measured: 1,5 - 2 years between time point 1 and time point 2
Gray matter volume
cm3
Measured: 1,5 - 2 years between time point 1 and time point 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start4 Sep 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, svanrooden, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322121
- Sponsor's protocol ID
- NL83653.058.23
- Status last verified
- Sep 2025
- First submitted
- 11 Dec 2023
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clarifying the Vascular Aspects of Dementia; Natural History Study
- ClinicalTrials.gov ID
- NCT06322121
- Acronym / sponsor ID
- NL83653.058.23
- Conditions
- Dementia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 20 Mar 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.
Cerebral amyloid angiopathy (CAA), a common cerebrovascular small vessel disease (SVD), is a frequently (98%) found co-morbidity at autopsy in patients with Alzheimer's disease (AD). Current in vivo hallmarks of CAA represent changes relatively late in the disease process and leaves CAA in AD often undetected. Recently, it was shown that decreased vascular reactivity (VR) measured with blood oxygen level dependent (BOLD) MRI, after visual stimulus, is an early CAA marker. With BOLD-MRI to detect decreased VR in different stages of AD, it was shown that increasing stages of AD associate with decreasing VR independent of age, classic SVD markers and atrophy. Moreover, VR is associated with cognitive deficits. Therefore, cross-sectional data indicate that decreased VR is an important co-morbidity already in early stages of AD with an independent effect on disease severity. In this respect, the study aim is to determine the natural course of the decrease of VR in both controls and (early stage) AD patients to monitor AD disease progression. This is an essential step to aid in the development and application of effective treatment as it is expected that CAA can cause/worsen AD pathology.
Detailed description
Rationale: Cerebral amyloid angiopathy (CAA), a common cerebrovascular small vessel disease (SVD), is a frequently (98%) found co-morbidity at autopsy in patients with Alzheimer's disease (AD). Current in vivo hallmarks of CAA represent changes relatively late in the disease process and leaves CAA in AD often undetected. Recently, it was shown that decreased vascular reactivity (VR) measured with blood oxygen level dependent (BOLD) MRI, after visual stimulus, is an early CAA marker. With BOLD-MRI to detect decreased VR in different stages of AD, it was shown that increasing stages of AD associate with decreasing VR independent of age, classic SVD markers and atrophy. Moreover, VR is associated with cognitive deficits. Therefore, cross-sectional data indicate that decreased VR is an important co-morbidity already in early stages of AD with an independent effect on disease severity. In this respect, the study aim is to determine the natural course of the decrease of VR in both controls and (early stage) AD patients to monitor AD disease progression. This is an essential step to aid in the development and application of effective treatment as it is expected that CAA can cause/worsen AD pathology.
Objective: To investigate longitudinal changes in VR in patients with subjective cognitive impairment (SCI), mild cognitive impairment (MCI) and AD dementia compared with controls. To investigate whether VR predicts progression of disease severity (cognitive decline) over a time period of 3 years and to investigate if decreased VR at baseline predicts increasing severity of other MRI markers for AD and SVD-markers at follow-up.
Study design: an longitudinal observational case - control study.
Study population: 30 AD patients, 30 patients with mild cognitive impairment and 30 patients with subjective cognitive impairment plus 30 controls, 50-90 yr old.
Main study parameters/endpoints: 1) 3T MRI: the amplitude of the BOLD response in percentage signal change between stimulus on and off, time-to-peak response (sec), and time-to-baseline (sec) after discontinuation of the visual stimulus, classic signs of CAA (intracranial hemorrhage, lobar microbleeds, subarachnoidal hemorrhage and superficial siderosis) and SVD markers (number of small subcortical infarcts and lacunes, volume of white matter hyperintensities (WMHs), perivascular spaces in the basal ganglia and centrum semiovale, number and location of deep microbleeds and grey matter volume). 2) Neuropsychological assessment 3) Baseline characteristics, 4) DNA: APOE ε genotype.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This is a non-therapeutic group relatedness study in only capacitated subjects. In order to achieve the aim of the study AD patients are needed. Vascular reactivity has potential to determine the role of the vascular aspects in AD. The risks of this research are minimal (risk of every day life), because there are no consequences to the health of the participant. We will keep the burden at a minimum. The research will consist of a 60 minutes MRI scan, a neuropsychological assessment of 1 hour and collection of 2 ml saliva (if not already collected at baseline).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dementia patients | – | Other: MRIPatients with a dementia diagnosis; probable Alzheimer or mixed-type dementia |
| MCI patients | – | Other: MRIPatients with a MCI diagnosis; patients demonstrating cognitive deficits on neuropsychological testing but not fulfilling the criteria for dementia. |
| SCI patients | – | Other: MRIPatients not demonstrating cognitive deficits on neuropsychological testing are classified as SCI |
| Controls | – | Other: MRIControl subject without cognitive complaints |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who attended a memory clinic and healthy controls
Key inclusion criteria (13 listed)
- For this study three different routes for inclusion exists. Inclusion criteria for each group separately are shown below.
Key exclusion criteria (17 listed)
- Contra-indication to MRI scanning:
- Specific contraindications to fMRI
- MMSE < 19 points (measured at moment of screening or at memory clinic with a maximum of 6 months in retrospect)
- Severe physical restrictions (completely wheelchair dependent)
- Age above 90
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 |
|---|---|---|
| MRIAssessment of vascular reactivity and CAA/SVD MRI markers | Other | Controls, Dementia patients, MCI patients, SCI patients |
Primary outcome
Vascular reactivity - BOLD amplitude
Time frame: 1,5 - 2 years between time point 1 and time point 2
The change in BOLD signal in response to visual stimulation as measured by the amplitude of the BOLD response in percentage signal change between stimulus on and off.
Vascular reactivity - time-to-peak
Time frame: 1,5 - 2 years between time point 1 and time point 2
The time-to-peak response (sec) is defined as the duration from the beginning of visual stimulation to the peak response.
Vascular reactivity - time-to-baseline
Time frame: 1,5 - 2 years between time point 1 and time point 2
The time-to-baseline response (sec) is defined as the duration from the end of the stimulus to baseline.
9 secondary outcomes
Intracranial hemorrhage
Time frame: 1,5 - 2 years between time point 1 and time point 2
Lobar microbleeds
Time frame: 1,5 - 2 years between time point 1 and time point 2
Subarachnoidal hemorrhage
Time frame: 1,5 - 2 years between time point 1 and time point 2
Superficial siderosis
Time frame: 1,5 - 2 years between time point 1 and time point 2
Lacunes
Time frame: 1,5 - 2 years between time point 1 and time point 2
Volume of white matter hyperintensities (WMHs)
Time frame: 1,5 - 2 years between time point 1 and time point 2
Perivascular spaces in the basal ganglia
Time frame: 1,5 - 2 years between time point 1 and time point 2
Perivascular spaces in the centrum semiovale
Time frame: 1,5 - 2 years between time point 1 and time point 2
Gray matter volume
Time frame: 1,5 - 2 years between time point 1 and time point 2
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 15 Sep 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Dementia
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Recruiting
Momentary Coping Prompts and Hair Steroids in College Students
Emotional Regulation, Alcohol Drinking in College
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
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?
An observational study of Dementia, 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 13 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 15 Sep 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?
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?
Vascular reactivity - BOLD amplitude (time frame: 1,5 - 2 years between time point 1 and time point 2). The study lists 3 primary outcomes in all. 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 15 Sep 2025.