Applied Cognition Benchmarking Study

NCT ID: NCT06222385

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-07
• Study Completion Date: 2023-06-08

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Sleep Opportunity-Sleep Deprivation

Participant randomized to overnight sleep period with a morning wake period on first visit of cross-over study.

Group Type: EXPERIMENTAL

Device measurements during overnight sleep and morning wake

Intervention Type: DIAGNOSTIC_TEST

Overnight period and morning period device measurements

Sleep Deprivation-Sleep Opportunity

Participant randomized to overnight sleep deprivation period with a morning recovery sleep period on first visit of cross-over study.

Group Type: EXPERIMENTAL

Device measurements during overnight wake and morning sleep

Intervention Type: DIAGNOSTIC_TEST

Overnight period and morning period device measurements

Interventions

Device measurements during overnight sleep and morning wake

Overnight period and morning period device measurements

Intervention Type: DIAGNOSTIC_TEST

Device measurements during overnight wake and morning sleep

Overnight period and morning period device measurements

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Participants must have a Montreal Cognitive Assessment (MoCA) score at least 26.

2. Participants must have a Geriatric Depression Scale (GDS) 15-item score of 4 or less.

Exclusion Criteria

1. 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).

2. Participants with a history of significant neurological disease or history of epilepsy.

3. Participants with cardiovascular disease or cardiovascular risk factors (smoking or hypertension).

4. Participants with diabetes.

5. Participants with traumatic brain injury, or serious mental illness including bipolar disorder, schizophrenia, major depressive disorder or post-traumatic stress disorder.

6. Participants who have taken in the past 30 days prescribed or overthe- counter (OTC) stimulants, sleeping medications, or psychiatric medications including antidepressants.

7. 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.

8. 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.

9. Participants planning travel to alternate time zones within two weeks of study participation

10. Participants with travel plans or conflicts that would prevent them from either Study Visit.

11. Participants who are enrolled in other research studies and are receiving an investigational drug within 30 days of the planned start date.

12. 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.

13. 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.

14. 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

15. Participants who have a pre-planned surgery or medical procedure that would interfere with the conduct of the study.

16. Participants who have an implanted medical device or contraindications that would exclude MRIs

17. Participants with a serious infection requiring medical attention in the past 30 days

18. Participants with a diagnosis of substance use-disorder in the past 2 years.

19. Participants with known acute or chronic kidney disease and/or compromised GFR.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida Health

OTHER

Sponsor Role: collaborator

Applied Cognition

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carla Vandeweerd, PhD

Role: PRINCIPAL_INVESTIGATOR

UF Health

Locations

UF Health - Precision Health Research Center

The Villages, Florida, United States

Countries

United States

Other Identifiers

AC.2022.02

Identifier Type: -

Identifier Source: org_study_id