Evidence map›Paper›PMID 30261917›Full record

Trial reportAlzheimer's research & therapy2018

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).

Elizabeth Finger, Scott Berry, Jeffrey Cummings, Kristy Coleman, Robin Hsiung, Howard H Feldman, Adam Boxer

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Alzheimer's research & therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03260920 (A Phase 2 Clinical Trial of Intranasal Oxytocin for Frontotemporal Dementia), which is not on this map. Cited by 23 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 2 pooled it
4.8field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03260920 phase2unknown statusnot on this map

A Phase 2 Clinical Trial of Intranasal Oxytocin for Frontotemporal Dementia

TypeinterventionalSponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sRan2018 to 2024Enrolled112ConditionsFrontotemporal DementiaArmsSyntocinon
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 35 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Article
  8. Article
  9. Review
  10. New Approaches to the Treatment of Frontotemporal Dementia.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2023
    Article
  11. Review
  12. The contribution of behavioral features to caregiver burden in FTLD spectrum disorders.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2022
    Article
  13. Review
  14. The Role of Oxytocin in Social Circuits and Social Behavior in Dementia.Methods in molecular biology (Clifton, N.J.) · 2022
    Article
  15. Review
  16. Review
  17. Apathy: Neurobiology, Assessment and Treatment.Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology · 2021
    Article
  18. Review
  19. Developments in treating the nonmotor symptoms of stroke.Expert review of neurotherapeutics · 2020
    Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 7 institutions in 2 countries.

Elizabeth FingerDepartment of Clinical Neurological Sciences, Schulich School of Medicine and Dentistry, University of Western Ontario, London, ON, Canada. elizabeth.finger@lhsc.on.ca.ORCID 0000-0003-4461-7427
Scott BerryBerry Consultants, Austin, TX, USA.
Jeffrey CummingsCleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV, USA.
Kristy ColemanParkwood Institute and Lawson Health Research Institute, 550 Wellington Road South, London, ON, N6C 0A7, Canada.
Robin HsiungDepartment of Medicine, Division of Neurology, University of British Columbia, Vancouver, BC, Canada.
Howard H FeldmanDepartment of Neurosciences, Alzheimer's Disease Cooperative Study, University of California, San Diego, CA, USA.
Adam BoxerDepartment of Neurology, University of California San Francisco School of Medicine, San Francisco, CA, USA.
Berry & Associates (United States) · USCleveland Clinic · USLawson Health Research Institute · CAUniversity of British Columbia · CAUniversity of California San Diego · USUniversity of California, San Francisco · USWestern University · CA

Funding

Training - The Frontotemporal Lobar Degeneration Clinical Research ConsortiumU54NS092089 · NINDS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI BOXER, ADAM L. · 2014 to 2018
$6.4M
CIHR 363926NINDS NIH HHS U54 NS092089
6 · The paper itself

Abstract

backgroundThere are currently no treatments for empathy deficits in neuropsychiatric disorders. Acute administration of the hormone oxytocin has been associated with symptomatic improvements across animal models and several neuropsychiatric disorders, but results of the majority of oxytocin randomised controlled trials (RCTs) of longer duration have been negative or inconclusive. This lack of efficacy of may be due to rapid habituation to oxytocin with chronic dosing. 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.

methodsStage 1 will identify which of three dose schedules is most promising based on change in the primary outcome measure, the Neuropsychiatric Inventory apathy/indifference domain score, over 6 weeks of treatment. In stage 2, additional patients are enrolled at the most promising dose for preliminary efficacy analysis when combined with stage 1 to determine if a phase 3 trial is warranted. Objective measures include facial expression recognition, cerebrospinal fluid (CSF) oxytocin levels, and behavioural ratings of videotaped interactions.

resultsA total of 20 patients per arm will be entered into stage 1 for a total of 60 patients. In stage 2, an additional 40 patients will be enrolled in the most promising dose arm.

conclusionsThe use of adaptive, crossover designs and inclusion of objective measures of change in CSF oxytocin levels and social behaviour will improve the efficiency and conclusiveness of RCTs of oxytocin and other symptomatic treatments in neuropsychiatric disorders.

trial registrationClinicalTrials.gov, NCT03260920 . Registered on August 24, 2017.

Indexed as

Research DesignSocial BehaviorAdministration, IntranasalApathyCross-Over StudiesEmpathyFemaleFrontotemporal DementiaHumansMaleNeurodegenerative DiseasesNeuropsychological TestsOxytocinSample SizeTreatment OutcomeOxytocinAdaptive designApathyClinical trialCrossover designEmpathyFrontotemporal dementiaOxytocin

Identifiers

PMID30261917
PMCPMC6161323
OpenAlexW2892727357

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.