Oxytocin Nasal Spray for Frontotemporal Dementia
(FOXY Trial)

Recruiting in Palo Alto (17 mi)

+10 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The purpose of this study is to assess the safety, tolerability and effects on behaviour of Syntocinon given intranasally (by a spray into the nostrils) compared to placebo (an inactive saline substance that contains no medication) in participants with frontotemporal dementia/Pick's disease. This study will take place in approximately 15 centres across Canada and the United States. Approximately 112 patients in total will be enrolled in this study. In the first phase we will examine which of three different dosing schedules of oxytocin may be more effective. In the second phase of the study, patients entering the study will be randomized to the oxytocin dosing schedule that appeared most effective in the first phase.

Eligibility Criteria

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.

Inclusion Criteria

Written informed consent must be obtained and documented (from the patient or, where jurisdictions allow it, from their substitute decision maker)

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

I experience moderate to severe lack of interest or concern.

+4 more

Exclusion Criteria

I am currently using medication on my cervix.

Participant has speech difficulties that in the opinion of the investigator would be incompatible with neuropsychology and safety assessments

Your heart beats too slow (less than 50 beats per minute) or too fast (more than 100 beats per minute).

+10 more

Participant Groups

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.

3Treatment groups

Experimental Treatment

Group I: Medium DoseExperimental Treatment1 Intervention

Group II: Low DoseExperimental Treatment1 Intervention

Group III: High DoseExperimental Treatment1 Intervention