The main aim of the present study is to improve our understanding of the role of blood-brain barrier function and cerebral perfusion in dementia of the Alzheimer*s type.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
neurodegeneratieve aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study measures are blood brain barrier permeability as measured by
T1-weighted dynamic contrast MRI; and cerebral perfusion as measured by
Arterial Spin Labeling MRI.
Secondary outcome
Not applicable
Background summary
The number of Alzheimer patients increases dramatically and will have doubled
by 2030. Yet, the cause of Alzheimer*s disease (AD) is still unknown. This lack
of knowledge has hampered the search for effective treatments for dementia of
the AD type. Recently, new MRI techniques have been developed to measure
microscopic vascular changes in the brain, such as decreased blood supply and
blood-brain barrier leakage. Partly based on knowledge acquired with these
techniques, there is an increasing recognition that vascular pathology plays a
significant role in the pathogenesis of AD. We hypothesize that microvascular
dysfunction - more specifically *cerebral perfusion and blood-brain barrier
leakage* - is a determinant of cognitive decline and cortical atrophy in AD.
Study objective
The main aim of the present study is to improve our understanding of the role
of blood-brain barrier function and cerebral perfusion in dementia of the
Alzheimer*s type.
Study design
The present study is a cross-sectional observational MRI study.
Study burden and risks
Individuals with contraindications for MRI and the contrast agent Gadovist will
be excluded. Risks associated with participants are therefore negligible. The
burden for patients with AD or prodromal AD is restricted to a 1 hour MRI scan
session (45 minutes scanning plus preparations), including contrast
administration. Other variables will be obtained from the standard diagnostic
procedure of the memory clinic. The burden for healthy participants is a test
session of 1.5 hours, including MRI with contrast administration, global
cognitive assessment, blood pressure, and clinical history. The burden for all
participants is minimal and the study is group related.
Dr. Tanslaan 12
6229 ET Maastricht
NL
Dr. Tanslaan 12
6229 ET Maastricht
NL
Listed location countries
Age
Inclusion criteria
Patients with AD:
• Informed consent before participation in the study
• Received standard diagnostic procedure according to the Parelsnoer Initiative procedure
• Diagnosed with dementia of the Alzheimer*s type
• Clinical dementia rating (CDR) of 1, which means a mild to moderate stage of dementia
• MMSE >= 20 and patients are mentally competent This inclusion criterion is conform the Parelsnoer Initiative inclusion criteria. By the Parelsnoer Initiative, individuals with an MMSE >=18 are considered mentally competent.;Patients with prodromal AD:
• Informed consent before participation in the study
• Received standard diagnostic procedure according to the Parelsnoer Initiative procedure
• Diagnosis of prodromal dementia according to the Dubois criteria (16)
• CDR of 0.5, which suggests a very mild stage of dementia
• Memory impairment defined as Delayed Recall on Verbal Learning Test (15 WLT) <1.5 SD
• MMSE >= 20 and patients are mentally competent.
• Medial temporal lobe atrophy scale MTA >= 1 (17) OR abnormal levels of Aß42, t-tau or p-tau;Healthy participants:
• Informed consent before participation in the study
• No Diagnosis of dementia, prodromal dementia, or mild cognitive impairment.
• MMSE >= 26
• No substantial memory complaints (according to participant ánd partner/relative)
• Age, gender and education is matched to the patient groups.
Exclusion criteria
• Contraindications for scanning (e.g. brain surgery, cardiac pacemaker, metal implants, claustrophobia, large body tattoos)
• Contraindications for contrast agent Gadovist (renal failure) as determined by the estimated Glomular Filtration Rate eGFR < 30 mL/min.
• Major vascular disorders (e.g. stroke, heart disease)
• Psychiatric or neurological disorders (e.g. Major depression; history of schizophrenia; bipolar disorder; psychotic disorder NOS or treatment for a psychotic disorder; cognive impairment due to alcohol abuse; epilepsy, Parkinson*s disease, MS, brain surgery, brain trauma, electroshock therapy, kidney dialysis, Meniere*s disease, brain infections)
• Structural abnormalities of the brain
• Cognitive impairment due to alcohol/drug abuse
• Absence of reliable informant (for AD patient groups)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL36156.068.11 |