Status:
COMPLETED
Applied Cognition Benchmarking Study
Lead Sponsor:
Applied Cognition
Collaborating Sponsors:
University of Florida Health
Conditions:
Healthy
Eligibility:
All Genders
55-65 years
Phase:
NA
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 cognitiv...
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, hypert...
Eligibility Criteria
Inclusion
- Participants must have a Montreal Cognitive Assessment (MoCA) score at least 26.
- Participants must have a Geriatric Depression Scale (GDS) 15-item score of 4 or less.
Exclusion
- 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.
- Participants who are enrolled in other research studies and are receiving an investigational drug within 30 days of the planned start date.
- Participants who have any condition that, in the opinion of the Sponsor Principal Investigator, would compromise the well-being of the participant or the study or prevent the participant from meeting or performing study requirements.
- Participants with absolute or relative contraindications to MRI imaging based on current up-to-date screening questionnaires including claustrophobia, inability to lie still on their back for 30-45 minutes or require sedation prior to the MRI.
- Participants with a head circumference greater than 60 cm that would prevent use of a high-resolution 64 channel MRI head coil required for this study
- Participants who have a pre-planned surgery or medical procedure that would interfere with the conduct of the study.
- Participants who have an implanted medical device or contraindications that would exclude MRIs
- Participants with a serious infection requiring medical attention in the past 30 days
- Participants with a diagnosis of substance use-disorder in the past 2 years.
- Participants with known acute or chronic kidney disease and/or compromised GFR.
Key Trial Info
Start Date :
November 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2023
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06222385
Start Date
November 7 2022
End Date
June 8 2023
Last Update
January 24 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UF Health - Precision Health Research Center
The Villages, Florida, United States, 32159