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DementiaNCT06322121

Vascular Aspects in Dementia: Part 2

An observational study of Dementia, run by Leiden University Medical Center at 1 site in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
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  • 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.

Netherlands1 site
  • Leids Universitair Medisch Centrum

    Leiden, 2333 ZA

Other trials in Netherlands

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 groups in NCT06322121
Study groupRoleWhat they receive
Dementia patientsPatients with a dementia diagnosis; probable Alzheimer or mixed-type dementia
Receives: Other: MRI
MCI patientsPatients with a MCI diagnosis; patients demonstrating cognitive deficits on neuropsychological testing but not fulfilling the criteria for dementia.
Receives: Other: MRI
SCI patientsPatients not demonstrating cognitive deficits on neuropsychological testing are classified as SCI
Receives: Other: MRI
ControlsControl subject without cognitive complaints
Receives: Other: MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  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

  3. 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)
  1. Intracranial hemorrhage

    number

    Measured: 1,5 - 2 years between time point 1 and time point 2

  2. Lobar microbleeds

    number

    Measured: 1,5 - 2 years between time point 1 and time point 2

  3. Subarachnoidal hemorrhage

    number

    Measured: 1,5 - 2 years between time point 1 and time point 2

  4. Superficial siderosis

    absent / focal / disseminated

    Measured: 1,5 - 2 years between time point 1 and time point 2

  5. Lacunes

    number

    Measured: 1,5 - 2 years between time point 1 and time point 2

  6. Volume of white matter hyperintensities (WMHs)

    cm3

    Measured: 1,5 - 2 years between time point 1 and time point 2

  7. 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

  8. Perivascular spaces in the centrum semiovale

    0= no PVS

    1. < 10 PVS
    2. 11-20 PVS
    3. 21-40 PVS
    4. >40 PVS

    Measured: 1,5 - 2 years between time point 1 and time point 2

  9. 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.

  1. First posted20 Mar 2024
  2. Study start4 Sep 2023
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

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)
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

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.

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