Intranasal Oxytocin for Frontotemporal Dementia

Conditions:Neurology, Neurology, Neurology
Therapuetic Areas:Neurology
Age Range:30 - 80
Start Date:January 31, 2018
End Date:September 1, 2021

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A Phase 2 Clinical Trial of Intranasal Oxytocin for Frontotemporal Dementia

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 substance that contains no medication) in participants with frontotemporal
dementia/Pick's disease. This study will take place in approximately 15 centres across Canada
and the United States. Approximately 112 patients in total will be enrolled in this study. In
the first phase we will examine which of three different dosing schedules of oxytocin may be
more effective. In the second phase of the study, patients entering the study will be
randomized to the oxytocin dosing schedule that appeared most effective in the first phase.

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

- 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

- 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

- 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

- 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

- 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.
We found this trial at
Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Kimiko Domoto-Reilly, MD
Phone: 206-221-9038
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
Seattle, WA
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4940 Eastern Ave
Baltimore, Maryland 21224
(410) 550-0100
Principal Investigator: Chiadi U Onyike, MD
Phone: 410-550-9020
Johns Hopkins Bayview Medical Center There is no better story in American medicine in the...
Baltimore, MD
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Charlestown, Massachusetts 02129
Principal Investigator: Brad Dickerson, MD
Charlestown, MA
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Los Angeles, California 90095
(310) 825-4321
Principal Investigator: Mario Mendez, MD
Phone: 310-478-3711
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
Los Angeles, CA
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630 W 168th St
New York, New York
Principal Investigator: Edward Huey, MD
Phone: 212-305-6284
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
New York, NY
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San Francisco, California 94143
Principal Investigator: Adam Boxer, MD
Phone: 415-476-0661
San Francisco, CA
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Vancouver, British Columbia V6T 1W5
Principal Investigator: Robin Hsiung, MD
Phone: (604) 822-0324
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