Impact of Emotional Mimicry and Oxytocin on Frontotemporal Dementia

What Was Tested

In this phase 2 trial, researchers set out to test Oxytocin.

It had two arms (groups): Intranasal Oxytocin (experimental) and Saline Nasal Mist (placebo comparator).

Participants will be randomized to receive intranasal saline mist (placebo) on opposite visits from the interventional drug visit 2 or 3.

The registry classes the interventions as drug.

More on the Plan

Frontotemporal dementia (FTD) and Pick's disease cause changes in personality, behaviour, and emotional responses.

However, these drugs do not help all patients who experience blunting of emotion and loss of empathy.

Who Took Part

Enrollment: 52 actual participants took part.

It was open to people of any sex aged from 30 years up to 85 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Meet consensus criteria for probable behavioural variant FTD (bvFTD). Age and sex matched with patients. Mini-Mental State Exam (MMSE) scores \>27.

The full record lists 4 inclusion and 20 exclusion criteria; among the exclusions: history of stroke; intracranial haemorrhage or other medical or neurological disorder apart from ftd that could affect cognition; diagnosis of bipolar disorder or schizophrenia not better accounted for by the diagnosis of ftd.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

In the crossover set-up each of the participants took both Oxytocin and the comparison in turn, acting as their own control.

Blinding on both sides kept the participants and researchers unaware of who received Oxytocin.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2013-09-12 with completion listed for 2017-12-21.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Functional magnetic resonance imaging (fMRI) BOLD signal (time frame: 2 weeks).

It also tracked 1 secondary outcome, for example Cognitive and Emotional Task performance.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 52 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.