Intranasal Oxytocin for Frontotemporal Dementia

• Register: ClinicalTrials.gov
• Last refreshed on: 19 December 2023
• Main ID: NCT03260920
• Date of registration: 19/07/2017
• Prospective Registration: Yes
• Primary sponsor: Lawson Health Research Institute
• Public title: Intranasal Oxytocin for Frontotemporal Dementia FOXY
• Scientific title: A Phase 2 Clinical Trial of Intranasal Oxytocin for Frontotemporal Dementia
• Date of first enrolment: January 31, 2018
• Target sample size: 112
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03260920
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Canada, United States

Key inclusion & exclusion criteria

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.



Age minimum: 30 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Frontotemporal Dementia

Intervention(s)

Drug: Syntocinon

Primary Outcome(s)

Change in Neuropsychiatric Inventory (NPI) apathy/indifference domain score [Time Frame: Up to 20 weeks]

Secondary Outcome(s)

Change in the Revised Self-Monitoring Scale score [Time Frame: Up to 20 weeks]

Change in emotional facial expression recognition performance [Time Frame: Up to 20 weeks]

Change in modified Clinicians Global Impression of Change (apathy) scores [Time Frame: Up to 20 weeks]

Secondary ID(s)

FTDOXY17EF

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Berry Consultants

Canadian Institutes of Health Research (CIHR)

Weston Brain Institute