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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
Must not have
Current use of topical prostaglandin medications applied to the cervix
History of stroke, other neurologic or psychiatric disorder other than FTD that is considered to better account for behavioural symptoms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 20 weeks
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently using medication on my cervix.
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I have a history of stroke or neurological/psychiatric disorders not including FTD.
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My high blood pressure is not under control.
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I haven't used any experimental drugs or devices recently.
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I am not pregnant, breastfeeding, nor planning to conceive during the study.
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I have had a heart attack in the last 2 years or suffer from heart failure.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Neuropsychiatric Inventory (NPI) apathy/indifference domain score

Side effects data

From 2014 Phase 2 trial • 30 Patients • NCT01183221
14%
Headache
7%
Runny nose
7%
Fatigue
7%
Burning in throat after nasal spray
7%
Sinuses tender
7%
Felt body/joint pain
4%
Slowed thought process
4%
Difficulty hearing
4%
Mild diarrhea
4%
Shortness of Breath
4%
Watery eyes
4%
Lack of focus
4%
Breasts tender
4%
Difficulty sleeping
100%
80%
60%
40%
20%
0%
Study treatment Arm
Syntocinon
Placebo

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

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
1,392 Previous Clinical Trials
26,529,333 Total Patients Enrolled
2 Trials studying Frontotemporal Dementia
59 Patients Enrolled for Frontotemporal Dementia
Lawson Health Research InstituteLead Sponsor
681 Previous Clinical Trials
431,228 Total Patients Enrolled
5 Trials studying Frontotemporal Dementia
1,139 Patients Enrolled for Frontotemporal Dementia
Berry ConsultantsOTHER
14 Previous Clinical Trials
57,819 Total Patients Enrolled

Media Library

Syntocinon (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03260920 — Phase 2
~14 spots leftby Dec 2025
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