Blood-brain barrier leakage in dementia A dynamic contrast-enhanced MRI study

Blood-brain barrier leakage in dementia A dynamic contrast-enhanced MRI study - Blood-brain barrier leakage in dementia

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44871

Enrollment

140

Registered

2014-04-25

Start date

2014-11-06

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neurodegeneratieve aandoeningen dementia

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients (baseline): * Informed consent before participation in the study * Age of 55 and older * Diagnosed with AD, VaD, mixed AD and VaD, mild cognitive impairment, vascular cognitive impairment and subjective cognitive impairment * MMSE * 20 and patients are mentally competent (in general, individuals with an MMSE *18 are considered mentally competent) ;Healthy participants (baseline): * Informed consent before participation in the study * Age of 55 and older * No Diagnosis of dementia, prodromal dementia, or mild cognitive impairment. * MMSE * 26 * No substantial memory complaints (according to participant) * Average age, gender and education is similar to the patient groups.;Follow-up participants with leakage: * Informed consent before participation in the follow-up study * MMSE * 20 * Participation in baseline study * Blood-brain barrier leakage is apparent on baseline post-contrast FLAIR sequence ;Follow-up participants without leakage: * Informed consent before participation in the follow-up study * MMSE * 20 * Participation in baseline study * Blood-brain barrier leakage is not apparent on baseline post-contrast FLAIR sequence * Average age, gender and diagnosis is similar to the follow-up participants with leakage group.

Exclusion criteria

Exclusion criteria: * Contraindications for MR 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

Design outcomes

Primary

Measure	Time frame
The main study measures are blood brain barrier permeability as measured by T1-weighted dynamic contrast MRI; and cognitive performance as measured by the neuropsychological assessment of the standard diagnostic procedure of the memory clinic, including global cognition (Mini Mental State examination), memory performance (Verbal Learning Test), mental speed (Letter Digit Substitution Test), and attention (Stroop task and Concept Shifting Test). Another outcome measure is the status of MRI visible cerebrovascular pathology (i.e. white matter hyperintensities, lacunar infarctions, microbleeds).	—

Measure

Time frame

The main study measures are blood brain barrier permeability as measured by T1-weighted dynamic contrast MRI; and cognitive performance as measured by the neuropsychological assessment of the standard diagnostic procedure of the memory clinic, including global cognition (Mini Mental State examination), memory performance (Verbal Learning Test), mental speed (Letter Digit Substitution Test), and attention (Stroop task and Concept Shifting Test). Another outcome measure is the status of MRI visible cerebrovascular pathology (i.e. white matter hyperintensities, lacunar infarctions, microbleeds).

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Secondary

Measure	Time frame
Gray matter atrophy	—

Countries

Netherlands

Outcome results