- Study Director: Adam Boxer, MD, PhD
- Sponsor: Lawson Health Research Institute
- Status: Active, not recruiting
- Official Study Title: Intranasal Oxytocin for Frontotemporal Dementia (FOXY)
- ClinicalTrials.gov Identifier: NCT03260920
- Conditions Studied: Frontotemporal dementia (FTD)
- Intervention: Syntocinon
- Phase: Phase 2
- Duration of Participation:
Purpose of the Study
The purpose of this study is to evaluate the safety and tolerability of Syntocinon given intranasally compared to placebo in patients with frontotemporal dementia/Pick’s disease (FTD).
Eligibility
Inclusion Criteria:
- Diagnosis of probable FTD (behavioral variant FTD, FTD-semantic subtype or FTD-progressive nonfluent aphasia) with supportive brain imaging (centrally rated frontotemporal atrophy score ≥2& on brain MRI or CT) or known FTD causing genetic mutation.
- 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 behavior 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 behavioral 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.
What to Expect
Testing: Neurological and physical examinations, MRIs, one PET scan, at least two lumbar punctures, cognitive testing and neuropsychiatric assessments, EKGs, telephone calls, blood and urine specimen collection, and vital signs
The Frequency of Visits: Every 6 weeks
Materials Needed Before Evaluation: Prior to participating in the trial, the patient will need a diagnosis of probable frontotemporal dementia/Pick’s disease.
Costs: No costs will be charged for any of the study procedures. Parking will be validated at UCSF public garages for all study visits.
Contact Information
Coordinator: [email protected]
Clinical Trials Nurse: Whitney Walker, MS, CNS, RN – [email protected], 415.353.7532
