Objective: 1. To determine whether vascular reactivity is lowered in memory clinic patients with mixed and pure AD pathology. 2. To define whether vascular reactivity upon visual activation is associated with CAA or with other small vessel disease (…
ID
Source
Brief title
Condition
- Other condition
- Vascular haemorrhagic disorders
Synonym
Health condition
hersenaandoening
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 microbleeds and grey matter volume). 2) Neuropsychological
assessment 3) Baseline characteristics, 4) DNA: APOE * genotype.
Secondary outcome
NA
Background summary
Rationale: In patients with Alzheimer*s disease (AD), cerebral amyloid
angiopathy (CAA) is a frequently found co-morbidity at autopsy. Post-mortem
studies have shown that up to 98% of AD patients show moderate to severe CAA,
however currently clinical data are limited. Recent research shows a prominent
role of vascular damage as first hallmark of AD. Therefore, detection of CAA in
patients with AD offers increased insight into etiology of AD, and is expected
to be helpful in the development of efficient therapies against AD. Vascular
reactivity measured with BOLD MRI is a sensitive quantitative marker of vessel
damage in hereditary CAA, even before classical radiological hallmarks of the
disease become overt. This opens the possibility to study early, or subtle,
manifestations of CAA as comorbidity in AD at several stages of the disease.
Hypotheses are that increasing dementia severity associates with decreasing
vascular reactivity.
Study objective
Objective: 1. To determine whether vascular reactivity is lowered in memory
clinic patients with mixed and pure AD pathology. 2. To define whether vascular
reactivity upon visual activation is associated with CAA or with other small
vessel disease (SVD) neuroimaging markers and cardiovascular risk factors. 3.
To establish whether vascular reactivity is independently associated with
(additional) cognitive deficits.
Study design
Study design: Observational cross sectional case-control study.
Study burden and risks
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 charges at a minimum. The research will only
consist of a 30-45 minutes MRI scan, a neuropsychological assessment of 1 hour
(if not already performed at memory clinic) and collection of 2 ml saliva.
Albinusdreef 2
Leiden 2300 RC
NL
Albinusdreef 2
Leiden 2300 RC
NL
Listed location countries
Age
Inclusion criteria
Patients who attended the memory clinic of the Leiden University Medical
Center/ Bronovo/ Reinier de Graaf hospital within one year ago
• Diagnosed with probable Alzheimer's disease
• Diagnosed as Mild cognitive impairment
• Diagnosed as Subjective cognitive impairment
• Diagnosed as Vascular dementia
• Capable of giving informed consent (see appendix)Control subjects
• Healthy adults without memory complaints aged between 40-90 years old
t>üâ
Exclusion criteria
- Contra-indication to MRI scanning:
• Claustrophobia
• Pacemakers and defibrillators
• Nerve stimulators
• Intracranial clips
• Intraorbital or intraocular metallic fragments
• Cochlear implants
• Ferromagnetic implants
• Hydrocephaluspump
• Intra-utrine device (not all types)
• An iron wire behind the teeth
• 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) (this
cutoff was also used in the Leiden 85-Plus study30)
- Severe physical restrictions (completely wheelchair dependent)
- Age above 90
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL69241.058.19 |