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Hormone Therapy

Oxytocin Nasal Spray for Frontotemporal Dementia (FOXY Trial)

Phase 2

Waitlist Available

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of probable FTD (behavioural variant FTD, FTD-semantic subtype or FTD-Progressive Nonfluent Aphasia) with supportive brain imaging (centrally rated frontotemporal atrophy score of 2 or greater on brain MRI or CT) or known FTD causing genetic mutation

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 20 weeks

Awards & highlights

FOXY Trial Summary

This trial is testing the safety and effects of oxytocin given as a nasal spray to people with frontotemporal dementia or Pick's disease, compared to a placebo. Approximately 112 patients will be enrolled at 15 centers in the US and Canada, and will be given either oxytocin or the placebo nasal spray. The trial will happen in two phases, first testing different doses of oxytocin to see which is most effective, and then randomly assigning patients in the second phase to either the most effective dose of oxytocin or the placebo.

Who is the study for?

This trial is for individuals with frontotemporal dementia or Pick's disease who have a caregiver able to assist daily. Participants must be capable of giving consent, have certain cognitive function scores (FTLD-CDR score 0-2 and MMSE >10), and stable medications for cognition/behavior. Exclusions include pregnancy, other major neurological disorders, unstable medical conditions, recent investigational drug use, extreme heart rates, plans for long-term care within the study period, and uncontrolled hypertension.Check my eligibility

What is being tested?

The study tests Syntocinon nasal spray against a placebo in patients with frontotemporal dementia across Canada and the U.S., aiming to find safe dosing schedules and observe behavioral effects. Initially testing three dosages to determine effectiveness before randomizing new participants into the most effective schedule identified.See study design

What are the potential side effects?

While specific side effects are not listed here, intranasal oxytocin may cause local irritation or discomfort at the site of administration. Systemic side effects could potentially include changes in mood or behavior given its role as a neurotransmitter/hormone.

FOXY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with FTD and have either supportive brain scans or a known genetic mutation.

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I experience moderate to severe lack of interest or concern.

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My medications for cognition or mood have been stable for at least 30 days.

FOXY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 20 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 20 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 20 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Neuropsychiatric Inventory (NPI) apathy/indifference domain score

Secondary outcome measures

Change in emotional facial expression recognition performance

Change in modified Clinicians Global Impression of Change (apathy) scores

Change in the Revised Self-Monitoring Scale score

Side effects data

From 2014 Phase 2 trial • 30 Patients • NCT01183221

14%

Headache

Runny nose

Fatigue

Burning in throat after nasal spray

Sinuses tender

Felt body/joint pain

Slowed thought process

Difficulty hearing

Mild diarrhea

Shortness of Breath

Watery eyes

Lack of focus

Breasts tender

Difficulty sleeping

100%

80%

60%

40%

20%

Study treatment Arm

Syntocinon

Placebo

FOXY Trial Design

3Treatment groups

Experimental Treatment

Group I: Medium DoseExperimental Treatment1 Intervention

Group II: Low DoseExperimental Treatment1 Intervention

Group III: High DoseExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oxytocin

FDA approved

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Weston Brain InstituteOTHER

11 Previous Clinical Trials

861 Total Patients Enrolled

1 Trials studying Frontotemporal Dementia

6 Patients Enrolled for Frontotemporal Dementia

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,340 Previous Clinical Trials

26,452,586 Total Patients Enrolled

2 Trials studying Frontotemporal Dementia

59 Patients Enrolled for Frontotemporal Dementia

Lawson Health Research InstituteLead Sponsor

656 Previous Clinical Trials

413,316 Total Patients Enrolled

5 Trials studying Frontotemporal Dementia

1,139 Patients Enrolled for Frontotemporal Dementia

Media Library

Syntocinon (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03260920 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people of all ages welcome to participate in this research?

"The minimum age requirement for this clinical trial is 30 years old and the maximum age limit is 80."

Answered by AI

How many subjects are included in this research?

"That is correct. The table on clinicaltrials.gov indicates that this study is currently enrolling patients. This trial was posted on 1/31/2018 and updated as recently as 7/30/2021. A total of 112 individuals will be participating at 11 sites."

Answered by AI

Does the FDA sanction Syntocinon for therapeutic use?

"While there is some evidence of Syntocinon's safety, as this is a Phase 2 trial, none of the data collected thus far supports efficacy."

Answered by AI

By how many people is this clinical trial being overseen?

"There are 11 sites conducting this trial at the moment, and they are situated in cities such as Los Angeles, Baltimore and New york. If you enroll in the study, try to select a location close to you to limit travel time requirements."

Answered by AI

Are there any volunteers needed for this current clinical trial?

"From what is indicated on clinicaltrials.gov, this trial is searching for test subjects right now. This trial was originally put up on 1/31/2018 and most recently updated 7/30/2021."

Answered by AI

Why is Syntocinon prescribed most frequently?

"Syntocinon, which is typically used to control bleeding, can also help with uterine contractions during labor and delivery."

Answered by AI

Do I fit the bill to join this clinical trial?

"This study is looking for 112 individuals between the ages of 30 and 80 who have semantic dementia. Additionally, it is essential that potential participants meet the following requirements: MMSE >10., 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., 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"

Answered by AI

Is there a significant body of research on Syntocinon?

"Hadassah University Medical Organization first looked into syntocinon in 2011 and, since then, there have been a total of 313 completed studies. As of now, 57 different research groups are actively recruiting for clinical trials related to this topic with many based in Los Angeles."

Answered by AI

Recent research and studies

Alzheimer's Research & TherapyJournal

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)

Finger, Elizabeth, Scott Berry, Jeffrey Cummings, Kristy Coleman, Robin Hsiung, Howard H. Feldman, and Adam Boxer. 2018. “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)”. Alzheimer's Research & Therapy. Springer Science and Business Media LLC. doi:10.1186/s13195-018-0427-2.

clinicaltrials.govStudy

Intranasal Oxytocin for Frontotemporal Dementia

2018. "Intranasal Oxytocin for Frontotemporal Dementia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03260920.

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