Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
112 participants
INTERVENTIONAL
2018-01-31
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Low Dose
Syntocinon
Intranasal Oxytocin
Medium Dose
Syntocinon
Intranasal Oxytocin
High Dose
Syntocinon
Intranasal Oxytocin
Interventions
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Syntocinon
Intranasal Oxytocin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
30 Years
80 Years
ALL
No
Sponsors
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Weston Brain Institute
OTHER
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Berry Consultants
OTHER
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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Locations
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UCLA
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Columbia University Medical Center
New York, New York, United States
University of Washington
Seattle, Washington, United States
University of British Columbia
Vancouver, British Columbia, Canada
Parkwood Institute
London, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada
Laval University
Québec, , Canada
Countries
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References
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Coleman KKL, Berry S, Cummings J, Hsiung GR, Laforce R, Huey E, Ducharme S, Tartaglia MC, Mendez MF, Onyike C, Domoto-Reilly K, Masellis M, Herrmann N, Porsteinsson A, Detry MA, Stewart C, Bosse AL, McGlothlin A, Dias B, Pandey S, Mayich M, Pasternak SH, Ruiz Garcia R, Restrepo-Martinez M, Feldman H, Boxer AL, Finger EC. Intranasal oxytocin for apathy in people with frontotemporal dementia (FOXY): a multicentre, randomised, double-blind, placebo-controlled, adaptive, crossover, phase 2a/2b superiority trial. Lancet Neurol. 2025 Feb;24(2):128-139. doi: 10.1016/S1474-4422(24)00456-3.
Finger E, Berry S, Cummings J, Coleman K, Hsiung R, Feldman HH, Boxer A. Adaptive crossover designs for assessment of symptomatic treatments targeting behaviour in neurodegenerative disease: a phase 2 clinical trial of intranasal oxytocin for frontotemporal dementia (FOXY). Alzheimers Res Ther. 2018 Sep 27;10(1):102. doi: 10.1186/s13195-018-0427-2.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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FTDOXY17EF
Identifier Type: -
Identifier Source: org_study_id