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

Authors

Finger, E. C., MacKinley, J., Blair, M., Oliver, L. D., Jesso, S., Tartaglia, M. C., Borrie, M., Wells, J., Dziobek, I., Pasternak, S., Mitchell, D. G. V., Rankin, K., Kertesz, A., Boxer, A.

Journal

Neurology, Volume: 84, No.: 2, Pages.: 174-181

Year of Publication

2015

Abstract

Objective: To determine the safety and tolerability of 3 doses of intranasal oxytocin (Syntocinon; Novartis, Bern, Switzerland) administered to patients with frontotemporal dementia (FTD). Methods: 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. Results: All 3 doses of intranasal oxytocin were safe and well tolerated. Conclusions: A multicenter trial is warranted to determine the therapeutic efficacy of long-term intranasal oxytocin for behavioral symptoms in FTD. Classification of evidence: 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. (PsycINFO Database Record (c) 2015 APA, all rights reserved). (journal abstract)

Bibtex Citation

@article{Finger_2014, doi = {10.1212/wnl.0000000000001133}, url = {http://dx.doi.org/10.1212/wnl.0000000000001133}, year = 2014, month = {dec}, publisher = {Ovid Technologies (Wolters Kluwer Health)}, volume = {84}, number = {2}, pages = {174--181}, author = {E. C. Finger and J. MacKinley and M. Blair and L. D. Oliver and S. Jesso and M. C. Tartaglia and M. Borrie and J. Wells and I. Dziobek and S. Pasternak and D. G. V. Mitchell and K. Rankin and A. Kertesz and A. Boxer}, title = {Oxytocin for frontotemporal dementia: A randomized dose-finding study of safety and tolerability}, journal = {Neurology} }

Keywords

clinical trial, clinical trials, drug therapy, drug tolerance, frontotemporal dementia, intranasal, oxytocin, safety, semantic dementia, tolerability

Countries of Study

Canada

Types of Dementia

Fronto Temporal (also known as Pick’s Disease)

Types of Study

Randomised Controlled Trial

Type of Outcomes

Other

Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions

Other