Status:
UNKNOWN
Intranasal Oxytocin for Frontotemporal Dementia
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
Weston Brain Institute
Canadian Institutes of Health Research (CIHR)
Conditions:
Frontotemporal Dementia
Eligibility:
All Genders
30-80 years
Phase:
PHASE2
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 substan...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT03260920
Start Date
January 31 2018
End Date
December 31 2024
Last Update
December 15 2023
Active Locations (11)
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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