Pilot Randomized, Double-Blind, Placebo-Controlled Crossover Trial Evaluating the Feasibility of an Intranasal Oxytocin in Improving Social Cognition in Individuals Living with Alzheimer’s Disease

Background: Individuals living with Alzheimer’s disease (AD) demonstrate extensive deficits in social cognition. To date, no studies have investigated the feasibility of an intranasal oxytocin (INOT) treatment to improve cognition individuals AD. Objective: We conducted a pilot trial determine recruitment feasibility, enrolment acceptability, and adherence INOT inform on subsequent design future randomized controlled (RCT). also estimated effect sizes potential cognitive function outcome measures related participants their caregivers. Methods: Four AD were enrolled single-center, randomized, double-blind, placebo-controlled crossover involving one-week period both (72 IU twice daily) placebo. Results: All reported treatment-causative or serious adverse events following repeated administration. While acceptability (100%) (placebo, 95%; INOT, 98%) excellent, was not acceptable (i.e., n = 4/58 screened met inclusion criteria). However, positive/large effects associated secondary outcomes self-reported health wellbeing, caregiver ‘burden’, intimacy interpersonal-bonding, No positive participant Conclusion: This RCT provides first evidence that administration is safe well-tolerated. Despite limitations sample size, moderate-to-large size improvements identified as well core functions ‘burden’ by caregiver. suggests broad-ranging beneficial which should be assessed RCTs.