FOXY: Intranasal Oxytocin for Frontotemporal Dementia

Sponsor

Lawson Health Research Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT03260920

Collaborator

Weston Brain Institute (Other), Canadian Institutes of Health Research (CIHR) (Other), Berry Consultants (Other)

112

Enrollment

Locations

Arms

Anticipated Duration (Months)

10.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Frontotemporal Dementia	Drug: Syntocinon	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

112 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

A Proof-of-Concept Double Blind Randomized Controlled, Cross-Over Adaptive Design TrialA Proof-of-Concept Double Blind Randomized Controlled, Cross-Over Adaptive Design Trial

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Double Blind

Primary Purpose:

Treatment

Official Title:

A Phase 2 Clinical Trial of Intranasal Oxytocin for Frontotemporal Dementia

Actual Study Start Date :

Jan 31, 2018

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low Dose	Drug: Syntocinon Intranasal Oxytocin Other Names: Intranasal Oxytocin
Experimental: Medium Dose	Drug: Syntocinon Intranasal Oxytocin Other Names: Intranasal Oxytocin
Experimental: High Dose	Drug: Syntocinon Intranasal Oxytocin Other Names: Intranasal Oxytocin

Arm

Intervention/Treatment

Experimental: Low Dose

Drug: Syntocinon

Intranasal Oxytocin

Other Names:

Intranasal Oxytocin

Experimental: Medium Dose

Drug: Syntocinon

Intranasal Oxytocin

Other Names:

Intranasal Oxytocin

Experimental: High Dose

Drug: Syntocinon

Intranasal Oxytocin

Other Names:

Intranasal Oxytocin

Outcome Measures

Primary Outcome Measures

Change in Neuropsychiatric Inventory (NPI) apathy/indifference domain score [Up to 20 weeks]
Pilot data from our two prior studies of oxytocin in FTD have driven the selection of the NPI as the primary outcome measure.

Secondary Outcome Measures

Change in emotional facial expression recognition performance [Up to 20 weeks]
Change in the Revised Self-Monitoring Scale score [Up to 20 weeks]
Change in modified Clinicians Global Impression of Change (apathy) scores [Up to 20 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA	Los Angeles	California	United States	90095
2	University of California, San Francisco	San Francisco	California	United States	94158
3	Johns Hopkins Bayview Medical Center	Baltimore	Maryland	United States	21224
4	Columbia University Medical Center	New York	New York	United States	10032
5	University of Washington	Seattle	Washington	United States	98195
6	University of British Columbia	Vancouver	British Columbia	Canada
7	Parkwood Institute	London	Ontario	Canada	N6C 0A7
8	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada
9	University Health Network	Toronto	Ontario	Canada
10	Montreal Neurological Institute and Hospital	Montreal	Quebec	Canada
11	Laval University	Quebec		Canada	G1J1Z4