Glymphatic dysfunction in cognitive impairment: a memory clinic study

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

Patients with mild Alzheimer's disease dementia, patients with mild cognitive impairment (MCI), and healthy subjects will be included.

In order to be eligible for the AD dementia-group, a subject must meet all of the following criteria:
- Mentally competent (MMSE=18) and able to give informed consent
- Informed consent before participation in the study
- Age > 55 years
- Diagnosis of dementia of the AD type

Criteria for the MCI-group:
- Mentally component (MMSE =18) and able to give informed consent
- Informed consent before participation in the study
- Age > 55 years
- Diagnosis of MCI or diagnosis of Mild Neurocognitive Disorder (DSM V)

Criteria for the control (cognitively normal) group:
- Mentally component (MMSE =18) and able to give informed consent
- Informed consent before participation in the study
- Age > 55 years
- MMSE = 26
- Average age and gender is similar to the patient groups

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Any significant disease or unstable medical condition that could influence neuropsychological testing (with the exception of a MCI or AD diagnosis)
- Major depression (according to the DSM IV) (< 12 months ago)
- Psychiatric history (schizophrenia, schizoaffective disorder, bipolar disorder or any history 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
- Unwillingness to be informed about potential abnormal MRI-findings

Additional exclusion criteria for the control group:
- A known diagnosis of mild cognitive impairment, prodromal dementia or dementia
- Substantial memory complaints (according to participant)

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoints are the interstitial fluid characteristics, the derived cerebral blood flow pulsatility index, and other derived MRI measures.

Secondary Outcome Measures

Name	Time	Method
The cerebral blood flow pulsatility and ISF characteristics will be analysed as a determinant of cognitive function, day-to-day functioning, sleep behaviour, physical activity and MRI markers. The CSF or blood and tear fluid biomarkers will also be taken into account in when determining the relation of ISF characteristics, pulsatility and the structural and functional brain properties in patients.