Safety Study of Intranasal Oxytocin in Frontotemporal Dementia

What Was Tested

The trial (phase 1) is built around Oxytocin.

Oxytocin is a hormone produced by the brain that appears to have important roles in social cognition and emotion in humans.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Saline nasal spray (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 23 actual participants took part.

It was open to people of any sex aged from 30 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 30-80 years. Meets "Neary criteria" for diagnosis of probable frontotemporal dementia. Neuroimaging (CT, MRI or SPECT scan) supports diagnosis of frontotemporal dementia. Provides written informed consent and has a caregiver or legally acceptable representative who provides written informed consent.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: has a history of a myocardial infarction within the last two years or congestive heart failure; current uncontrolled hypertension; current bradycardia (rate \< 50 beats per minute/bpm) or tachycardia (rate \> 100 bpm).

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

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

The Oxytocin group and the comparison group ran side by side rather than switching.

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 2011-06 with completion listed for 2013-10.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: 2 week).

It also tracked 6 secondary outcomes, for example Neuropsychiatric Inventory, Frontal Behavioural Inventory, Clinicians Global Impression of Change, Interpersonal Reactivity Index and Multi-faceted Empathy Test.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Oxytocin in 23 people.

Its size is small, so on its own it can only give an early look.

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.