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Adaptive crossover designs for assessment of symptomatic treatments targeting behaviour in neurodegenerative disease: a phase 2 clinical trial of intranasal oxytocin for frontotemporal dementia (FOXY)
Plain-language guide to PMID 30261917 (2018): crossover randomized controlled trial study of Oxytocin in 2, patients.
Key Facts
- PMID
- 30261917
- Journal
- Alzheimer's research & therapy
- Year
- 2018
- Study type
- Randomized Controlled Trial
- Authors
- Finger E et al. (7 authors)
- DOI
- 10.1186/s13195-018-0427-2
What This Study Did, in Plain Language
What Was Tested
This randomized controlled trial paper looks at Oxytocin.
The objective of the present study is to describe the design of a phase 2 adaptive randomised controlled crossover trial of intranasal oxytocin in frontotemporal dementia (FOXY) as an efficient model for future investigations of symptomatic treatments in neuropsychiatric and neurodegenerative disorders.
Objective measures include facial expression recognition, cerebrospinal fluid (CSF) oxytocin levels, and behavioural ratings of videotaped interactions.
Why It Was Studied
There are currently no treatments for empathy deficits in neuropsychiatric disorders.
Registered on August 24, 2017.
Who Took Part
The study group was 2, patients.
PubMed tags the participants as both men and women.
How the Study Was Run
In design terms this was a randomized and crossover study.
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 patients took both Oxytocin and the comparison in turn, acting as their own control.
The methods mention a period of 6 weeks.
What Was Measured
The subject headings attached to it are Apathy, Empathy, Frontotemporal Dementia, Neurodegenerative Diseases, Neuropsychological Tests, Oxytocin and Sample Size.
Author keywords: Adaptive design, Clinical trial and Crossover design.
What This Means in Plain Language
The paper is a randomized and crossover study of Oxytocin in 2, patients over 6 weeks.
With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.
Results are reported in around 3 sentences of the abstract; we leave them to the paper itself rather than summarise them.
The publication is from 2018 (Alzheimer's research & therapy), a journal based in England.
More context: the Oxytocin compound page, all human trials.
Our Notes on the Compound
Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.
Related Pages
Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.