Frontotemporal DementiaPhase 1FTDOXY10EFNCT01386333
Safety Study of Intranasal Oxytocin in Frontotemporal Dementia
A Phase 1 study testing oxytocin and Saline Nasal Mist in people with Frontotemporal Dementia, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Oxytocin is a hormone produced by the brain that appears to have important roles in social cognition and emotion in humans. In a pilot study, the effects of a single dose of oxytocin on measures of emotion recognition and behaviour in patients with Frontotemporal Dementia were investigated. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Frontotemporal Dementia
- What is being tested?
- oxytocin and Saline Nasal Mist
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to Oct 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30-80 years
- Meets "Neary criteria" for diagnosis of probable frontotemporal dementia
- Neuroimaging (CT, MRI or SPECT scan) supports diagnosis of frontotemporal dementia
- Provides written informed consent and has a caregiver or legally acceptable representative who provides written informed consent.
Who cannot join
- Has a 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
- Current use of prostaglandin medications
- Females who are pregnant or breastfeeding
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Cognitive Neurology and Alzheimer Research Centre
London, Ontario, N6A 4V2
About this study
Official title: A Phase I Dose Finding Study of Intranasal Oxytocin in Frontotemporal Dementia, Protocol # FTDOXY10EF
Oxytocin is a hormone produced by the brain that appears to have important roles in social cognition and emotion in humans. In a pilot study, the effects of a single dose of oxytocin on measures of emotion recognition and behaviour in patients with Frontotemporal Dementia were investigated. The results from the pilot study suggested that oxytocin may be associated with a modest improvement in neuropsychiatric behaviours seen in patients with Frontotemporal Dementia. To further examine the safety and tolerability of oxytocin in this disorder, the present study will examine the safety and tolerability of three different doses of intranasal oxytocin administered to patients with Frontotemporal Dementia twice daily for 1 week.
- Conditions
- Frontotemporal Dementia
- Being tested
- oxytocin, Saline Nasal Mist
- Keywords
- Frontotemporal Dementia, oxytocin, Pick's disease
- Medical subject headings
- Frontotemporal Dementia, Pick Disease of the Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxytocinDrug
Patients will be randomized to receive intranasal oxytocin or placebo in a dose escalation paradigm with three dose cohorts: 24IU, 48IU and 72IU of intranasal oxytocin twice daily for 1 week
Saline Nasal MistDrug
Placebo arm wil receive saline nasal mist sprays matched in number to oxytocin dose cohorts
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin 24IU | Experimental | Oxytocin 24 IU administered intranasally twice daily for 1 week Receives: Drug: oxytocin |
| Oxytocin 48 IU | Experimental | 48 IU of intranasal oxytocin administered twice daily for 1 week Receives: Drug: oxytocin |
| 72 IU oxytocin | Experimental | 72 IU of intranasal oxytocin administered twice daily for 1 week Receives: Drug: oxytocin |
| Saline nasal spray | Placebo comparator | Not described Receives: Drug: oxytocin; Drug: Saline Nasal Mist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Safety and Tolerability of 24 international units (IU), 48 IU and 72 IU of intranasal oxytocin administered twice daily for 1 week to patients with Frontotemporal Dementia as assessed by the number of participants with adverse events. Adverse events will be assessed by a standardized questionnaire and serum sodium levels will be monitored.
Measured: 2 week
Secondary outcomes (6)
Neuropsychiatric Inventory
Behavioural ratings at baseline and 1 week of oxytocin treatment compared to 1 week of placebo treatment
Measured: 1 week
Frontal Behavioural Inventory
Measured: 1 week
Clinicians Global Impression of Change
Measured: 1 week
Clinical Dementia Rating- Frontotemporal Lobar Degeneration
Measured: 1 week
Interpersonal Reactivity Index
Measured: 1 week
Multi-faceted Empathy Test
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frontotemporal DementiaStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Consortium of Canadian Centres for Clinical Cognitive Research
- Responsible party
- Principal investigator, Elizabeth Finger, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Elizabeth C Finger, MD, Principal investigator, University of Western Ontario, Lawson Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386333
- Sponsor's protocol ID
- R-11-232
- Other IDs
- 17783
- Acronym
- FTDOXY10EF
- Status last verified
- Nov 2013
- First submitted
- 29 Jun 2011
- Last updated
- 4 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Finger EC, MacKinley J, Blair M, Oliver LD, Jesso S, Tartaglia MC, Borrie M, Wells J, Dziobek I, Pasternak S, Mitchell DG, Rankin K, Kertesz A, Boxer A. Oxytocin for frontotemporal dementia: a randomized dose-finding study of safety and tolerability. Neurology. 2015 Jan 13;84(2):174-81. doi: 10.1212/WNL.0000000000001133. Epub 2014 Dec 10.
PubMed 25503617
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Finding Study of Intranasal Oxytocin in Frontotemporal Dementia, Protocol # FTDOXY10EF
- ClinicalTrials.gov ID
- NCT01386333
- Acronym / sponsor ID
- FTDOXY10EF / R-11-232
- Conditions
- Frontotemporal Dementia
- Keywords
- Frontotemporal Dementia, oxytocin, Pick's disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Consortium of Canadian Centres for Clinical Cognitive Research
- Study start
- Jun 2011
- Primary completion
- Oct 2013 (actual)
- First posted
- 1 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oxytocin is a hormone produced by the brain that appears to have important roles in social cognition and emotion in humans. In a pilot study, the effects of a single dose of oxytocin on measures of emotion recognition and behaviour in patients with Frontotemporal Dementia were investigated. The results from the pilot study suggested that oxytocin may be associated with a modest improvement in neuropsychiatric behaviours seen in patients with Frontotemporal Dementia. To further examine the safety and tolerability of oxytocin in this disorder, the present study will examine the safety and tolerability of three different doses of intranasal oxytocin administered to patients with Frontotemporal Dementia twice daily for 1 week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oxytocin 24IU | Experimental | Drug: oxytocinOxytocin 24 IU administered intranasally twice daily for 1 week |
| Oxytocin 48 IU | Experimental | Drug: oxytocin48 IU of intranasal oxytocin administered twice daily for 1 week |
| 72 IU oxytocin | Experimental | Drug: oxytocin72 IU of intranasal oxytocin administered twice daily for 1 week |
| Saline nasal spray | Placebo comparator | Drug: oxytocin, Drug: Saline Nasal Mist |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 30-80 years
- Meets "Neary criteria" for diagnosis of probable frontotemporal dementia
- Neuroimaging (CT, MRI or SPECT scan) supports diagnosis of frontotemporal dementia
- Provides written informed consent and has a caregiver or legally acceptable representative who provides written informed consent.
Key exclusion criteria (7 listed)
- Has a 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
- Current use of prostaglandin medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxytocinPatients will be randomized to receive intranasal oxytocin or placebo in a dose escalation paradigm with three dose cohorts: 24IU, 48IU and 72IU of intranasal oxytocin twice daily for 1 week | Drug | 72 IU oxytocin, Oxytocin 24IU, Oxytocin 48 IU, Saline nasal spray |
| Saline Nasal MistPlacebo arm wil receive saline nasal mist sprays matched in number to oxytocin dose cohorts | Drug | Saline nasal spray |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 2 week
Safety and Tolerability of 24 international units (IU), 48 IU and 72 IU of intranasal oxytocin administered twice daily for 1 week to patients with Frontotemporal Dementia as assessed by the number of participants with adverse events. Adverse events will be assessed by a standardized questionnaire and serum sodium levels will be monitored.
6 secondary outcomes
Neuropsychiatric Inventory
Time frame: 1 week
Frontal Behavioural Inventory
Time frame: 1 week
Clinicians Global Impression of Change
Time frame: 1 week
Clinical Dementia Rating- Frontotemporal Lobar Degeneration
Time frame: 1 week
Interpersonal Reactivity Index
Time frame: 1 week
Multi-faceted Empathy Test
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2013.
- Derived from this study: PubMed 25503617Finger EC, MacKinley J, Blair M, Oliver LD, Jesso S, Tartaglia MC, Borrie M, Wells J, Dziobek I, Pasternak S, Mitchell DG, Rankin K, Kertesz A, Boxer A. Oxytocin for frontotemporal dementia: a randomized dose-finding study of safety and tolerability. Neurology. 2015 Jan 13;84(2):174-81. doi: 10.1212/WNL.0000000000001133. Epub 2014 Dec 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth C Finger, MD principal investigator
University of Western Ontario, Lawson Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing oxytocin and Saline Nasal Mist in people with Frontotemporal Dementia, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: 2 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01386333, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2013.