Intranasal Oxytocin for Frontotemporal Dementia (FOXY)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03260920 |
Recruitment Status :
Recruiting
First Posted : August 24, 2017
Last Update Posted : January 17, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Frontotemporal Dementia | Drug: Syntocinon | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 112 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | A 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 : | January 31, 2018 |
Estimated Primary Completion Date : | January 31, 2023 |
Estimated Study Completion Date : | December 31, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Low Dose |
Drug: Syntocinon
Intranasal Oxytocin
Other Name: Intranasal Oxytocin |
Experimental: Medium Dose |
Drug: Syntocinon
Intranasal Oxytocin
Other Name: Intranasal Oxytocin |
Experimental: High Dose |
Drug: Syntocinon
Intranasal Oxytocin
Other Name: Intranasal Oxytocin |
- Change in Neuropsychiatric Inventory (NPI) apathy/indifference domain score [ Time Frame: 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.
- Change in emotional facial expression recognition performance [ Time Frame: Up to 20 weeks ]
- Change in the Revised Self-Monitoring Scale score [ Time Frame: Up to 20 weeks ]
- Change in modified Clinicians Global Impression of Change (apathy) scores [ Time Frame: Up to 20 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 30 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260920
United States, California | |
UCLA | Recruiting |
Los Angeles, California, United States, 90095 | |
Contact: Diana Chavez 310-478-3711 ext 48176 dianachavez@mednet.ucla.edu | |
Principal Investigator: Mario Mendez, MD | |
University of California, San Francisco | Recruiting |
San Francisco, California, United States, 94158 | |
Contact: Mary Koestler 415-476-0661 mary.koestler@ucsf.edu | |
Principal Investigator: Adam Boxer, MD | |
United States, Maryland | |
Johns Hopkins Bayview Medical Center | Recruiting |
Baltimore, Maryland, United States, 21224 | |
Contact: Toni White, MS 410-550-6486 twhite46@jhmi.edu | |
Principal Investigator: Chiadi U Onyike, MD | |
United States, New York | |
Columbia University Medical Center | Completed |
New York, New York, United States, 10032 | |
United States, Washington | |
University of Washington | Recruiting |
Seattle, Washington, United States, 98195 | |
Contact: Alicia Adams 206-221-9038 adamsali@uw.edu | |
Principal Investigator: Kimiko Domoto-Reilly, MD | |
Canada, British Columbia | |
University of British Columbia | Completed |
Vancouver, British Columbia, Canada | |
Canada, Ontario | |
Parkwood Institute | Recruiting |
London, Ontario, Canada, N6C 0A7 | |
Contact: S Jesso, BA 519-646-6000 cognitiveneurology@sjhc.london.on.ca | |
Principal Investigator: Elizabeth Finger, MD | |
Sunnybrook Health Sciences Centre | Completed |
Toronto, Ontario, Canada | |
University Health Network | Recruiting |
Toronto, Ontario, Canada | |
Contact: Daniela Mora-Fisher (416) 603-5800 daniela.mora-fisher@uhn.ca | |
Principal Investigator: Carmela Tartaglia, MD | |
Canada, Quebec | |
Montreal Neurological Institute and Hospital | Recruiting |
Montreal, Quebec, Canada | |
Contact: Michal Friedman (514) 398-5750 michal.friedman@mcgill.ca | |
Principal Investigator: Simon Ducharme, MD | |
Canada | |
Laval University | Recruiting |
Quebec, Canada, G1J1Z4 | |
Contact: Megane Lacombe-Thibault 418-649-0252 megane.lacombe-thibault@crchudequebec.ulaval.ca | |
Principal Investigator: Robert LaForce, MD |
Responsible Party: | Lawson Health Research Institute |
ClinicalTrials.gov Identifier: | NCT03260920 |
Other Study ID Numbers: |
FTDOXY17EF |
First Posted: | August 24, 2017 Key Record Dates |
Last Update Posted: | January 17, 2023 |
Last Verified: | January 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
oxytocin frontotemporal dementia apathy empathy |
Dementia Frontotemporal Dementia Aphasia, Primary Progressive Pick Disease of the Brain Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurocognitive Disorders Mental Disorders Neurodegenerative Diseases Frontotemporal Lobar Degeneration TDP-43 Proteinopathies |
Proteostasis Deficiencies Metabolic Diseases Aphasia Speech Disorders Language Disorders Communication Disorders Neurobehavioral Manifestations Neurologic Manifestations Oxytocin Oxytocics Reproductive Control Agents Physiological Effects of Drugs |