Intranasal Oxytocin for Frontotemporal Dementia (FOXY)
Primary Purpose
Frontotemporal Dementia
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Syntocinon
Sponsored by
About this trial
This is an interventional treatment trial for Frontotemporal Dementia focused on measuring oxytocin, frontotemporal dementia, apathy, empathy
Eligibility 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.
Sites / Locations
- UCLA
- University of California, San Francisco
- Johns Hopkins Bayview Medical Center
- Columbia University Medical Center
- University of Washington
- University of British Columbia
- Parkwood Institute
- Sunnybrook Health Sciences Centre
- University Health Network
- Montreal Neurological Institute and Hospital
- Laval University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Low Dose
Medium Dose
High Dose
Arm Description
Outcomes
Primary Outcome Measures
Change in Neuropsychiatric Inventory (NPI) apathy/indifference domain score
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
Change in emotional facial expression recognition performance
Change in the Revised Self-Monitoring Scale score
Change in modified Clinicians Global Impression of Change (apathy) scores
Full Information
NCT ID
NCT03260920
First Posted
July 19, 2017
Last Updated
October 4, 2023
Sponsor
Lawson Health Research Institute
Collaborators
Weston Brain Institute, Canadian Institutes of Health Research (CIHR), Berry Consultants
1. Study Identification
Unique Protocol Identification Number
NCT03260920
Brief Title
Intranasal Oxytocin for Frontotemporal Dementia
Acronym
FOXY
Official Title
A Phase 2 Clinical Trial of Intranasal Oxytocin for Frontotemporal Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 31, 2018 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Weston Brain Institute, Canadian Institutes of Health Research (CIHR), Berry Consultants
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frontotemporal Dementia
Keywords
oxytocin, frontotemporal dementia, apathy, empathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
A Proof-of-Concept Double Blind Randomized Controlled, Cross-Over Adaptive Design Trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double Blind
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low Dose
Arm Type
Experimental
Arm Title
Medium Dose
Arm Type
Experimental
Arm Title
High Dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Syntocinon
Other Intervention Name(s)
Intranasal Oxytocin
Intervention Description
Intranasal Oxytocin
Primary Outcome Measure Information:
Title
Change in Neuropsychiatric Inventory (NPI) apathy/indifference domain score
Description
Pilot data from our two prior studies of oxytocin in FTD have driven the selection of the NPI as the primary outcome measure.
Time Frame
Up to 20 weeks
Secondary Outcome Measure Information:
Title
Change in emotional facial expression recognition performance
Time Frame
Up to 20 weeks
Title
Change in the Revised Self-Monitoring Scale score
Time Frame
Up to 20 weeks
Title
Change in modified Clinicians Global Impression of Change (apathy) scores
Time Frame
Up to 20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Parkwood Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 0A7
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Montreal Neurological Institute and Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Laval University
City
Quebec
ZIP/Postal Code
G1J1Z4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30261917
Citation
Finger E, Berry S, Cummings J, Coleman K, Hsiung R, Feldman HH, Boxer A. Adaptive crossover designs for assessment of symptomatic treatments targeting behaviour in neurodegenerative disease: a phase 2 clinical trial of intranasal oxytocin for frontotemporal dementia (FOXY). Alzheimers Res Ther. 2018 Sep 27;10(1):102. doi: 10.1186/s13195-018-0427-2.
Results Reference
derived
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Intranasal Oxytocin for Frontotemporal Dementia
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