Could a nasal spray boost sleep and brain health in seniors?
NCT ID NCT07610343
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a nasal spray containing two medicines, dexmedetomidine and esketamine, can improve sleep quality and thinking abilities in older adults with mild-to-moderate Alzheimer's-related cognitive impairment and sleep problems. Sixty participants will receive either the active spray or a placebo twice a week for four weeks. The main goal is to see if sleep quality gets better, with a secondary look at whether thinking skills also improve.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dexmedetomidine and esketamine nasal spray
- What this could lead to
- If it works, this could point toward a new way to improve sleep and possibly slow cognitive decline in older adults with Alzheimer's disease.
- What could go wrong
- This is a small, early-phase trial with only 60 participants. The combination may cause side effects like low blood pressure, slow heart rate, or neuropsychiatric issues, and it may not improve sleep or cognition as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged ≥ 60 years. 2. Meeting the clinical diagnostic criteria for Alzheimer's disease, with mild cognitive impairment (MoCA score 18-25) or moderate cognitive impairment (MoCA score 10-17) due to Alzheimer's disease. 3. Comorbid with sleep disorders (Pittsburgh Sleep Quality Index \[PSQI\] score ≥ 7). 4. Signed informed consent. Exclusion Criteria: 1. Cognitive impairment/dementia due to other causes (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease dementia). 2. Unsuitable for intranasal administration due to nasal cavity diseases (e.g., rhinitis, nasal polyps, or nasal congestion of any cause). 3. Inability to communicate due to visual, auditory, language, or other reasons, or Mini-Mental State Examination (MMSE) score ≤ 9 or MoCA score ≤ 9. 4. History of schizophrenia, epilepsy, or Parkinson's disease, or confirmed diagnosis of glaucoma, hyperthyroidism, pheochromocytoma, or myasthenia gravis. 5. Confirmed diagnosis of restless legs syndrome or sleep apnea, or judged to be at high risk of moderate-to-severe sleep apnea according to STOP-Bang score, or Body Mass Index (BMI) \> 30 kg/m2. 6. History of stroke or transient ischemic attack within 12 months prior to enrollment, confirmed intracranial aneurysm, or elevated intracranial pressure from any cause. 7. Uncontrolled hypertension (e.g., hypertensive crisis or systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg prior to enrollment), myocardial infarction, unstable angina, revascularization surgery within 12 months prior to enrollment, or NYHA class III. 8. Sick sinus syndrome, severe sinus bradycardia (heart rate \< 50 beats/min), atrioventricular block above degree II without a pacemaker, corrected QT interval (Fridericia-corrected QTcF) ≥ 450 ms, or other severe arrhythmias (e.g., frequent premature ventricular contractions). 9. Uncontrolled diabetes (e.g., HbA1c \> 9%, diabetic ketosis, hyperglycemic coma, or hypoglycemia). 10. Severe hepatic dysfunction (Child-Pugh Class C), renal dysfunction (eGFR ≤ 30 ml/min/1.73m2), respiratory insufficiency (SpO2 \< 93% on room air), or other severe diseases (e.g., frailty with inability to walk independently, advanced-stage tumors). 11. Alcohol or drug dependence (manifested as strong cravings, uncontrolled use, and withdrawal symptoms upon cessation), or use of contraindicated medications. 12. Major surgery under general anesthesia within 12 weeks prior to enrollment, or planned surgery within 12 weeks. 13. Allergy to dexmedetomidine and/or esketamine. 14. Participation in other interventional clinical studies. 15. Any other conditions deemed unsuitable for study inclusion by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
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