Pharmacological Enhancement of Glymphatic Function in Humans (NCT07432997) | Clinical Trial Compass
CompletedPhase 1/2
Pharmacological Enhancement of Glymphatic Function in Humans
United States31 participantsStarted 2023-12-11
Plain-language summary
Alzheimer's disease is linked in part to the buildup of harmful proteins in the brain, including amyloid and tau. Most current treatments aim to remove these proteins directly. This study explores a different approach: helping the brain clear waste more effectively during sleep. The investigators will test whether certain medications can safely boost the brain's natural "cleaning system," known as the glymphatic system, in healthy older adults. Participants will receive controlled sleep treatments and blood tests to measure protein clearance. If successful, this strategy could support new therapies that work alongside existing Alzheimer's treatments.
Who can participate
Age range
55 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. In the opinion of the Principal Investigator, participants must be fluent in English and be able to understand the informed consent form approved by the Institutional Review Board (IRB). All participants must sign the study informed consent document indicating that they understand the purpose of procedures required for the study and are willing to participate in the study prior to any study procedures being performed.
. Participants may be men or women, age 55 - 65 years (inclusive). Enrollment will target equal number of men and women participants.
. Participants must have a MoCA score at least 26 for in-person assessment or 19 for over-the-phone assessment, unless waived by decision of the PI.
. Participants must have a GDS-15 score of 4 or less.
. Participants must provide an address and phone number where they can be accessible to the Study team for follow up.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean change from baseline in plasma Aβ42/Aβ40 ratio following dexmedetomidine treatment
Timeframe: Pre/post 4-hour sleep period
2
Mean change from baseline in plasma Aβ42/Aβ40 ratio following dexmedetomidine and midodrine treatment
Timeframe: Pre/post 4-hour sleep period
3
Mean change from baseline in plasma %p-tau217 following dexmedetomidine treatment
Timeframe: Pre/post 4-hour sleep period
4
Mean change from baseline in plasma %p-tau217 following dexmedetomidine and midodrine treatment
. Participants must agree to wear the GF Monitor per the Study Phase under baseline and dexmedetomidine infusion and be willing to complete all other aspects of the protocol.
Exclusion criteria
. Participants with a formal diagnosis of any sleep disorder (e.g., sleep apnea on 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 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 over-the-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 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.