Intranasal Oxytocin for Frontotemporal Dementia

Frontotemporal Dementia Clinical Trial

— FOXY  

Official title:

A Phase 2 Clinical Trial of Intranasal Oxytocin for Frontotemporal Dementia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03260920
• Other study ID #: FTDOXY17EF
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 31, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 112
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.68

• 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.

• Study partner who consents to study participation and who cares for/visits the patient daily for at least 3 hours/day and who can administer all trial medications.

• FTLD-CDR score 0-2.

• MMSE >10.

• Stable baseline medications related to cognition or behaviour for >=30 days such as acetylcholinesterase inhibitors, memantine, anti-depressants, antipsychotic agents, other mood stabilizers, benzodiazepines.

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

Exclusion Criteria:

• History of stroke, other neurologic or psychiatric disorder other than FTD that is considered to better account for behavioural symptoms.

• History of a myocardial infarction within the last two years or congestive heart failure.

• Current uncontrolled hypertension

• Current bradycardia (rate < 50 beats per minute/bpm) or tachycardia (rate > 100 bpm)

• Current hyponatremia (Na <135 mEq/L)

• Current use of topical prostaglandin medications applied to the cervix.

• Females who are pregnant or breastfeeding, or planning to conceive within the study period.

• Use of any investigational or experimental drug or device within the last 60 days prior to screening or within 5 half-lives of the experimental drug, whichever is longer.

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

• History of cancer except:

• If considered to be cured

• If not being actively treated with anti-cancer therapy or radiotherapy and, in the opinion of the investigator, not likely to require treatment in the ensuing 5 years

• For prostate cancer or basal cell carcinoma, no significant progression over the previous 2 years

• Any clinically significant hematological, endocrine, cardiovascular, renal, hepatic, gastrointestinal or neurological disease. If the condition has been stable for at least the past year and is judged by the investigator not to interfere with the patient's participation in the study, the patient may be included.

• For the CSF sub-study, current use of anticoagulant medications (warfarin, rivaroxaban, etc.).

• Plan for FTD patient to be placed into long-term care or plan for hospital admission for any kind of treatment within study period or if caregiver plans for holidays/respite care > 3 days during study period.

Related Conditions & MeSH terms

• Aphasia, Primary Progressive
• Dementia
• Frontotemporal Dementia
• Pick Disease of the Brain

Intervention

Drug:
• Syntocinon
Intranasal Oxytocin

Locations

Country	Name	City	State
Canada	Parkwood Institute	London	Ontario
Canada	Montreal Neurological Institute and Hospital	Montreal	Quebec
Canada	Laval University	Quebec
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario
Canada	University of British Columbia	Vancouver	British Columbia
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	UCLA	Los Angeles	California
United States	Columbia University Medical Center	New York	New York
United States	University of California, San Francisco	San Francisco	California
United States	University of Washington	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Berry Consultants, Canadian Institutes of Health Research (CIHR), Weston Brain Institute

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Neuropsychiatric Inventory (NPI) apathy/indifference domain score	Pilot data from our two prior studies of oxytocin in FTD have driven the selection of the NPI as the primary outcome measure.	Up to 20 weeks
Secondary	Change in emotional facial expression recognition performance		Up to 20 weeks
Secondary	Change in the Revised Self-Monitoring Scale score		Up to 20 weeks
Secondary	Change in modified Clinicians Global Impression of Change (apathy) scores		Up to 20 weeks