Glymphatic dysfunction in cognitive impairment: a memory clinic study
- Conditions
- Alzheimer's diseasedementia1004225810012272
- 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
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
- 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
Name Time Method <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
Name Time Method <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>