Intranasal Oxytocin for Frontotemporal Dementia

What Was Tested

The trial (phase 2) is built around Oxytocin.

Approximately 112 patients in total will be enrolled in this study.

It had three arms (groups): one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 112 planned participants were the target.

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: Current symptoms of social apathy/indifference as measured by NPI apathy/indifference severity subscale score \>= 2 indicating the presence of moderate to marked levels of apathy/indifference. Study partner who consents to study participation and who cares for/visits the patient daily for at least 3 hours/day and who can administer all trial medications. FTLD-CDR score 0-2. Stable baseline medications related to cognition or behaviour for \>=30 days such as acetylcholinesterase inhibitors, memantine, anti-depressants, antipsychotic agents, other mood stabilizers, benzodiazepines. Written informed consent must be obtained and documented (from the patient or, where jurisdictions allow it, from their substitute decision maker).

The full record lists 7 inclusion and 16 exclusion criteria; among the exclusions: history of stroke, other neurologic or psychiatric disorder other than ftd that is considered to better account for behavioural symptoms; history of a myocardial infarction within the last two years or congestive heart failure; current uncontrolled hypertension.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

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

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

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

It started in 2018-01-31 with completion listed for 2023-06-30.

It ran at 11 sites in Canada (6) and United States (5).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Neuropsychiatric Inventory (NPI) apathy/indifference domain score (time frame: Up to 20 weeks).

It also tracked 3 secondary outcomes, for example Change in emotional facial expression recognition performance, Change in the Revised Self-Monitoring Scale score and Change in modified Clinicians Global Impression of Change (apathy) scores.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 112 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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