drugset / Trial / NCT07610343

Intranasal Dexmedetomidine-esketamine on Sleep and Cognition in Older Adults With Mild-to-moderate Cognitive Impairment

NCT07610343

Phase 4 Not yet recruiting 60 enrolled Peking University First Hospital
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Patients with cognitive decline are frequently comorbid with sleep disorders which may in turn aggravate cognitive decline. Sedative dose dexmedetomidine improved sleep quality but incresed bradycardia and hypotension; low dose dexmedetomidine produce less side effects, but the sleep promoting effects are relatively weak. Low dose esketamine also has sleep-promoting effects but may produce neuropsychiatric side effects. Both dexmedetomidine and esketamine are approved for intranasal administration. We suppose that intranasal administration of dexmedetomidine-esketamine combination may improve sleep quality and therefore cognitive function in older ptients with Alzheimer's disease cognitive impairment and sleep disorders.

Timeline

Start
2026-06
Primary completion
2027-11
Completion
2027-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexmedetomidine Other / unclassified 0.4 ug/kg Intranasal
Subject Esketamine Other / unclassified 0.2 mg/kg Intranasal