Oxytocin Nasal Spray for Frontotemporal Dementia

(FOXY 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.

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.

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.¹²³⁴⁵

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.

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.¹³⁵⁶⁷