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FOXY

UnknownPhase 2

Intranasal Oxytocin for Frontotemporal Dementia

A Phase 2 Clinical Trial of Intranasal Oxytocin for Frontotemporal Dementia

Asset

Oxytocin

Listed sites

11

Recruiting sites

-

Enrollment

112

estimated

Study population

Frontotemporal dementia

Key I/E criteria

•MMSE ≥10•Study partner/caregiver required•Current anticoagulant use excluded

Primary endpoint

•Neuropsychiatric Inventory (NPI)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDFTDOXY17EF
NCT IDNCT03260920

Timeline

Milestones

Study first posted2017-08-24actual
Study start2018-01-31actual
Primary completion2023-06-30actual
Last update posted2023-12-15actual
Study completion2024-12-31estimated

Assets

Drug assets

Oxytocin

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age30 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric
2
Memory
1
Other (unclassified)
1

Memory

1 endpoint
Secondary/protocol endpoint

Change in emotional facial expression recognition performance

Time frame:Up to 20 weeks

change from baseline, improvement

Behavior / neuropsychiatric

2 endpoints
Primary/protocol endpoint

Change in Neuropsychiatric Inventory (NPI) apathy/indifference domain score

Time frame:Up to 20 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change in modified Clinicians Global Impression of Change (apathy) scores

Time frame:Up to 20 weeks

change from baseline, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Change in the Revised Self-Monitoring Scale score

Time frame:Up to 20 weeks

change from baseline, improvement

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.