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  • Oxytocin for frontotemporal dementia: a randomized dose-finding study of safety and tolerability.

Oxytocin for frontotemporal dementia: a randomized dose-finding study of safety and tolerability.

Neurology (2014-12-17)
Elizabeth C Finger, Julia MacKinley, Mervin Blair, Lindsay D Oliver, Sarah Jesso, Maria C Tartaglia, Michael Borrie, Jennie Wells, Isabel Dziobek, Stephen Pasternak, Derek G V Mitchell, Katherine Rankin, Andrew Kertesz, Adam Boxer
ABSTRACT

To determine the safety and tolerability of 3 doses of intranasal oxytocin (Syntocinon; Novartis, Bern, Switzerland) administered to patients with frontotemporal dementia (FTD). We conducted a randomized, parallel-group, double-blind, placebo-controlled study using a dose-escalation design to test 3 clinically feasible doses of intranasal oxytocin (24, 48, or 72 IU) administered twice daily for 1 week to 23 patients with behavioral variant FTD or semantic dementia (clinicaltrials.gov registration number NCT01386333). Primary outcome measures were safety and tolerability at each dose. Secondary measures explored efficacy across the combined oxytocin vs placebo groups and examined potential dose-related effects. All 3 doses of intranasal oxytocin were safe and well tolerated. A multicenter trial is warranted to determine the therapeutic efficacy of long-term intranasal oxytocin for behavioral symptoms in FTD. This study provides Class I evidence that for patients with FTD, intranasal oxytocin is not significantly associated with adverse events or significant changes in the overall neuropsychiatric inventory.

MATERIALS
Product Number
Brand
Product Description

USP
Oxytocin, United States Pharmacopeia (USP) Reference Standard
Oxytocin, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Oxytocin
Sigma-Aldrich
Oxytocin, lyophilized powder, ~15 IU/mg solid (Prepared from synthetic oxytocin)