Oxytocin Nasal Spray for Frontotemporal Dementia

(FOXY Trial)

Not currently recruiting at 11 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and effectiveness of an oxytocin nasal spray, known as Syntocinon, for individuals with frontotemporal dementia, a condition affecting behavior and personality. Researchers aim to determine if different doses of the spray can improve symptoms compared to a placebo, which contains no medication. The trial suits individuals with frontotemporal dementia who experience social withdrawal or lack of interest in activities. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications to join the trial?

The trial requires that your current medications related to cognition or behavior, like antidepressants or antipsychotics, have been stable for at least 30 days. If your medications meet this condition, you may not need to stop them.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Syntocinon nasal spray, containing intranasal oxytocin, is generally safe and well-tolerated. Studies have found that doses up to 72 IU twice a day are safe for individuals with frontotemporal dementia. Most side effects are mild, including dizziness, drowsiness, and nasal irritation. Some individuals also reported a runny nose, dry throat, headache, stomach ache, and anxiety. Overall, patients in previous studies responded well to the treatment, experiencing only minor issues. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Unlike the standard treatments for frontotemporal dementia, which often focus on managing symptoms with medications like antidepressants or antipsychotics, the investigational treatment Syntocinon is unique because it uses oxytocin, a hormone that plays a role in social bonding and emotional regulation. This nasal spray delivery method allows the hormone to quickly reach the brain, potentially improving social and emotional behavior more directly. Researchers are excited about Syntocinon because it targets the underlying social and emotional symptoms of dementia in a novel way, offering a new avenue for treatment that could complement or enhance existing therapies.

What evidence suggests that Syntocinon nasal spray might be an effective treatment for frontotemporal dementia?

Research has shown that oxytocin nasal spray might improve behavior in people with frontotemporal dementia (FTD). In one study, a single dose of oxytocin spray temporarily improved social behavior and mood. Other studies have found that using oxytocin every three days reduced apathy, meaning patients showed more interest in their surroundings. These findings suggest that oxytocin could help relieve some symptoms of FTD, even if the improvements are small. While the effects are modest, they offer hope for managing some symptoms of this condition. Participants in this trial will receive varying doses of oxytocin nasal spray to further evaluate its effectiveness. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4336088/

Oxytocin for frontotemporal dementia: A randomized dose- ... A single dose of intranasal oxytocin vs placebo was associated with a transient improvement in social and neuropsychiatric behaviors in patients with FTD. Thus, ...

2. thelancet.com thelancet.com/journals/laneur/article/PIIS1474-4422(24)00456-3/abstract

Intranasal oxytocin for apathy in people with frontotemporal ... Intranasal oxytocin given every third day was well tolerated and was associated with a small reduction in apathy in patients with frontotemporal dementia.

3. theaftd.org theaftd.org/posts/1ftd-in-the-news/blog-apathy-oxytocin-study/

Study Evaluates the Efficacy of Nasally Administered ... A study found that intranasal oxytocin doses provided a small but meaningful relief to apathy in people with FTD.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03260920

Intranasal Oxytocin for Frontotemporal Dementia 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)

5. ftdregistry.org ftdregistry.org/press/featured-study-foxy-intranasal-oxytocin-for-ftd/

FEATURED STUDY: FOXY-Intranasal Oxytocin for FTD A Phase 2 Clinical Trial of Intranasal Oxytocin for Frontotemporal Dementia seeks to assess the safety, tolerability, and effectiveness of one such potential ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01386333

Safety Study of Intranasal Oxytocin in Frontotemporal ... The results from the pilot study suggested that oxytocin may be associated with a modest improvement in neuropsychiatric behaviours seen in patients with ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11804147/

A systematic review of the safety of using intranasal oxytocin ... Adverse events reports were mostly mild, including dizziness, drowsiness, dry throat, nasal irritation, runny nose, stomach ache, headache, and anxiety.