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Glymphatic dysfunction in cognitive impairment: a memory clinic study

Recruiting
Conditions
Alzheimer's disease
dementia
10042258
10012272
Registration Number
NL-OMON56079
Lead Sponsor
Medisch Universitair Ziekenhuis Maastricht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
120
Inclusion Criteria

Patients with Alzheimer's disease (AD) dementia:
-Diagnosis of dementia of the AD type (McKhann et al. 2011)
-Age > 55 years
-Mentally competent (MMSE>=18) and able to give informed consent
-Informed consent before participation in the study

Patients with Mild cognitive impairments (MCI) or Subjective cognitive
impairment (SCI):
-Diagnosis of MCI (Albert et al. 2011) or diagnosis of Mild Neurocognitive
Disorder (DSM V) (Sachs-Ericsson and Blazer 2015) or diagnosis of SCI as given
by the memory clinic (SCI is defined by an individual experiencing subjective
complaints and visiting the memory clinic for these complaints, but not showing
a significant decline in objective cognitive assessment)
-Age > 55 years
-Mentally component (MMSE >=18) and able to give informed consent
-Informed consent before participation in the study

Control subjects:
-Mini-Mental State Examination (MMSE) >= 26
-Age > 55 years
-Mentally component (MMSE >=18) and able to give informed consent
-Informed consent before participation in the study

Exclusion Criteria

- Any significant disease or unstable medical condition that could influence
neuropsychological testing (with the exception of a SCI, MCI or AD diagnosis)
- Major depression (according to the DSM IV) (< 12 months ago)
- Psychiatric history (schizophrenia, schizoaffective disorder, bipolar
disorder or any his-tory of electroconvulsive therapy)
- Vascular dementia
- Ischemic or valvular heart disease or electrocardiographic evidence of atrial
fibrillation
- Recent transient ischemic attacks and ischemic or haemorrhagic stroke or
cerebrovascular accident (< 2 years or paired with cognitive decline within 3
months after incident)
- Obstructive sleep apnoea syndrome
- Normal Pressure Hydrocephalus, M. Huntington, Parkinson*s disease,
Frontotemporal dementia, Motor neuron diseases, Multiple sclerosis, Epilepsy
- Systemic inflammation, such as active rheumatoid arthritis
- Diabetes
- Cognitive impairment due to alcohol/drug abuse
- Structural abnormalities of the brain, such as tumours or stroke lesions
- Inability to provide informed consent
- Any contraindication for MRI: metallic implants, pacemaker, claustrophobia,
pregnancy, tattoos in the head/neck region (with potential exception of
permanent
make-up after assessment with SOP permanent make-up)
- Unwillingness to be informed about potential abnormal MRI-findings

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>- To determine group differences on glymphatic metrics (ISF, pulsatility)<br /><br>between the patient groups (AD, MCI, SCI) and cognitively normal control<br /><br>subjects.<br /><br>- To determine the relation between glymphatic metrics (ISF, pulsatility),<br /><br>neurodegeneration and lower cognitive performance.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>- To determine the association between ISF characteristics, arterial<br /><br>pulsatility and demographical data, data on sleep and physical activity.<br /><br>- To determine the association of MRI derived glymphatic metrics, brain tissue<br /><br>markers and functional cerebral networks<br /><br>- To determine the associations of glymphatic metrics and biochemical markers<br /><br>of Alzheimer*s disease</p><br>
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