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CompletedPhase 1 / PHASE2

Pharmacological Enhancement of Glymphatic Function in Humans

The Effect of Dexmedetomidine on Glymphatic Function in the Human Brain

Lead sponsor

Applied Cognition

Assets

Dexmedetomidine / Dexmedetomidine and Midodrine

Listed sites

2

Recruiting sites

-

Enrollment

31

actual

Study population

Alzheimer’s disease

Key I/E criterion

MoCA ≥26

Primary endpoints

Plasma Aβ42/Aβ40 ratio following dexmedetomidine treatmentPlasma Aβ42/Aβ40 ratio following dexmedetomidine and midodrine treatmentPhosphorylated tau 217 (p-tau217)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDAC.2023.01
NCT IDNCT07432997

Timeline

Milestones

Study start2023-12-11actual
Primary completion2024-09-13actual
Study completion2024-09-13actual
Study first posted2026-02-25actual
Last update posted2026-02-25actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

Potential participants must satisfy the following criteria to be enrolled in the study:

1. 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.

2. Participants may be men or women, age 55 - 65 years (inclusive). Enrollment will target equal number of men and women participants.

3. 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.

4. Participants must have a GDS-15 score of 4 or less.

5. Participants must provide an address and phone number where they can be accessible to the Study team for follow up.

6. 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

Potential participants who meet any of the following criteria will be excluded from participating in the study:

1. 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).

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

3. Participants with cardiovascular disease 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 over-the-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 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 who are enrolled in other research studies and are receiving an investigational drug within 30 days of the planned start date for visit 1.

10. Participants who have any condition that, in the opinion of the Principal Investigator, would compromise the well-being of the participant or the study or prevent the participant from meeting or performing study requirements.

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

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

13. Any significant neurological impairment in the opinion of the Principal Investigator that would affect the GF Monitor data.

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

15. Participants with urinary retention or requiring to void several times during the night

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Amyloid biomarkers
2
Other (unclassified)
2

Amyloid biomarkers

2 endpoints
Primary/protocol endpoint

Mean change from baseline in plasma Aβ42/Aβ40 ratio following dexmedetomidine treatment

Time frame:Pre/post 4-hour sleep period

change from baseline, improvement

Primary/protocol endpoint

Mean change from baseline in plasma Aβ42/Aβ40 ratio following dexmedetomidine and midodrine treatment

Time frame:Pre/post 4-hour sleep period

change from baseline, improvement

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

Mean change from baseline in plasma %p-tau217 following dexmedetomidine treatment

Time frame:Pre/post 4-hour sleep period

Phosphorylated tau 217 (p-tau217)

change from baseline, improvement

Primary/protocol endpoint/low confidence

Mean change from baseline in plasma %p-tau217 following dexmedetomidine and midodrine treatment

Time frame:Pre/post 4-hour sleep period

Phosphorylated tau 217 (p-tau217)

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.