Oxytocin Nasal Spray for Frontotemporal Dementia

(FOXY Trial)

Recruiting at 10 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

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

Must not be taking: Topical prostaglandins, Anticoagulants

Disqualifiers: Stroke, Myocardial infarction, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

112 Participants Needed

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.

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).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Examine which of three different dosing schedules of oxytocin may be more effective

10 weeks

Treatment Phase 2

Patients are randomized to the oxytocin dosing schedule that appeared most effective in the first phase

10 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Syntocinon

Trial Overview 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.

Participant Groups

Group I: Medium Dose Experimental Treatment 1 Intervention

Group II: Low Dose Experimental Treatment 1 Intervention

Group III: High Dose Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

678

Recruited

421,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

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

Lead Sponsor

Trials

668

Recruited

424,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Weston Brain Institute

Collaborator

Trials

13

Recruited

990+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Berry Consultants

Collaborator

Trials

16

Recruited

58,200+