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Intranasal Oxytocin for Frontotemporal Dementia (FOXY)

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ClinicalTrials.gov Identifier: NCT03260920
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : June 28, 2018
Sponsor:
Collaborators:
The Weston A. Price Foundation
Canadian Institutes of Health Research (CIHR)
Berry Consultants
Information provided by (Responsible Party):
Lawson Health Research Institute

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 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.

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 : September 1, 2021
Estimated Study Completion Date : September 1, 2021


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in emotional facial expression recognition performance [ Time Frame: Up to 20 weeks ]
  2. Change in the Revised Self-Monitoring Scale score [ Time Frame: Up to 20 weeks ]
  3. Change in modified Clinicians Global Impression of Change (apathy) scores [ Time Frame: Up to 20 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
United States, California
UCLA Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Elivra Jimenez         
Principal Investigator: Mario Mendez, MD         
UCSF Not yet recruiting
San Francisco, California, United States, 94143
Contact: Caitlin Glennon         
Principal Investigator: Adam Boxer, MD         
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21218
Contact: Sarah Lawrence    410-516-8000    email@jhmi.edu   
Principal Investigator: Chiadi U Onyike, MD         
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Samantha Krivensky         
Principal Investigator: Brad Dickerson, MD         
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Masood Manoochehri    604-875-4111    email@columbia.edu   
Principal Investigator: Edward Huey, MD         
United States, Washington
University of Washington Not yet recruiting
Seattle, Washington, United States, 98195
Contact: Christina Caso         
Principal Investigator: Kimiko Domoto-Reilly, MD         
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada
Contact: Eloise Nicklin    (604) 875-4111    email@ubc.ca   
Principal Investigator: Robin Hsiung, MD         
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 Recruiting
Toronto, Ontario, Canada
Contact: Katie Sharp    (416) 480-6100    email@sunnybrook.ca   
Principal Investigator: Mario Masellis, MD         
University Health Network Recruiting
Toronto, Ontario, Canada
Contact: Cassandra Anor    (416) 603-2581    email@uhn.ca   
Principal Investigator: Carmela Tartaglia, MD         
Canada, Quebec
McGill University Recruiting
Montreal, Quebec, Canada
Contact: Sophie Pawlowski    (514) 398-4455    email@mcgill.ca   
Principal Investigator: Simon Ducharme, MD         
Sponsors and Collaborators
Lawson Health Research Institute
The Weston A. Price Foundation
Canadian Institutes of Health Research (CIHR)
Berry Consultants

Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03260920     History of Changes
Other Study ID Numbers: FTDOXY17EF
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
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

Keywords provided by Lawson Health Research Institute:
oxytocin
frontotemporal dementia
apathy
empathy

Additional relevant MeSH terms:
Frontotemporal Dementia
Pick Disease of the Brain
Dementia
Aphasia, Primary Progressive
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Neurodegenerative Diseases
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs