Measuring and Monitoring Brain Health in Older Adults: The Applied Cognition Glymphatic Function Study at The Villages
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Applied Cognition
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Non-invasive MRI - fast functional MRI
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a cross-over randomized study to validate the Sponsor investigational medical device against measurements of glymphatic function from MRI-based neuroimaging, EEG, blood biomarkers and cognitive tests in healthy older volunteers.
Detailed Description
The study population will consist of healthy individuals, ages 55 to 65, that are cognitively normal and do not have a medical history of neurological or sleep disorder, cardiovascular disease, hypertension, or diabetes. The objectives of this study are to define whether sleep- and wake-associated device measurements (i) faithfully reflect glymphatic function measured by gold-standard contrast enhanced MRI and non-invasive MRI-based measures of glymphatic function; (ii) replicate pre-clinical findings between sleep EEG power bands and glymphatic flow; (iii) predict plasma levels of Alzheimer's disease (AD)-related biomarkers; and (iv) predict morning cognitive performance.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants must have a Montreal Cognitive Assessment (MoCA) score at least
- •Participants must have a Geriatric Depression Scale (GDS) 15-item score of 4 or less.
Exclusion Criteria
- •Participants with a formal diagnosis of any sleep disorder (e.g., sleep apnea on positive-airway-pressure (PAP) therapy, insomnia, restless leg syndrome, circadian rhythm sleep disorder, parasomnia).
- •Participants with a history of significant neurological disease or history of epilepsy.
- •Participants with cardiovascular disease or cardiovascular risk factors (smoking or hypertension).
- •Participants with diabetes.
- •Participants with traumatic brain injury, or serious mental illness including bipolar disorder, schizophrenia, major depressive disorder or post-traumatic stress disorder.
- •Participants who have taken in the past 30 days prescribed or overthe- counter (OTC) stimulants, sleeping medications, or psychiatric medications including antidepressants.
- •Participants who consume more than 400 mg/day of caffeine. Participants will be required to not consume caffeine beginning 12pm on the day-of the sleep study.
- •Female Participants who consume more than 3 alcoholic drinks on any day or more than 7 drinks per week. Male participants who consume more than 4 alcoholic drinks on any day or more than 14 drinks per week.
- •Participants planning travel to alternate time zones within two weeks of study participation
- •Participants with travel plans or conflicts that would prevent them from either Study Visit.
Outcomes
Primary Outcomes
Non-invasive MRI - fast functional MRI
Time Frame: Immediately before and immediately after each sleep/wake period
Sleep- and wake-associated device measurements (impedances in milli-ohms) faithfully reflect glymphatic function measured by non-invasive MRI measures of glymphatic function using fast functional MRI (f-MRI) low-frequency vasomotor oscillations, Hz.
Non-invasive MRI - multi-echo arterial spin-labeling
Time Frame: Immediately before and immediately after each sleep/wake period
Sleep- and wake-associated device measurements (impedances in milli-ohms) faithfully reflect glymphatic function measured by non-invasive MRI measures of glymphatic function using multi-echo arterial spin-labeling (ME-ASL)-MRI (glial-vascular water transport) (flow in ml/sec).
Non-invasive MRI - diffusion-based intravoxel incoherent motion
Time Frame: Immediately before and immediately after each sleep/wake period
Sleep- and wake-associated device measurements (impedances in milli-ohms) faithfully reflect glymphatic function measured by non-invasive MRI measures of glymphatic function using diffusion-based intravoxel incoherent motion (IVIM)-MRI (long-distance water transport) (diffusion signal, a.u.).
Contrast-enhanced MRI
Time Frame: Immediately after the overnight sleep/wake period
Overnight sleep- and wake-associated device measurements (impedances in milli-ohms) faithfully reflect glymphatic function measured by ROI parenchymal signal intensity using gold-standard contrast-enhanced MRI for gray and white matter ROI.
Non-invasive MRI - T1/FLAIR-based assessment
Time Frame: Immediately before and immediately after each sleep/wake period
Sleep- and wake-associated device measurements (impedances in milli-ohms) faithfully reflect glymphatic function measured by non-invasive MRI measures of glymphatic function using T1/FLAIR-based assessment of MRI-visible perivascular spaces (MVPVS) that are structural indicators of perivascular impairment, (a.u.).
Non-invasive MRI - phase-contrast
Time Frame: Immediately before and immediately after each sleep/wake period
Sleep- and wake-associated device measurements (impedances in milli-ohms) faithfully reflect glymphatic function measured by non-invasive MRI measures of glymphatic function using phase-contrast (PC)-MRI (aqueductal cerebral spinal fluid (CSF) flow) (flow in ml/sec).
Secondary Outcomes
- Cognitive function - symbol digit modality test(Immediately after the sleep/wake period)
- Sleep EEG(Measurements sampled every 5 to 10 minutes during the overnight sleep period)
- Cognitive function - psychomotor vigilance test(Immediately after the sleep/wake period)
- Blood biomarkers(Immediately before and immediately after each sleep/wake period)
- Cognitive function - trail making tests A&B(Immediately after the sleep/wake period)
- Cognitive function - digits forward recall(Immediately after the sleep/wake period)