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Frontotemporal DementiaPhase 2FOXYNCT03260920

Intranasal Oxytocin for Frontotemporal Dementia

A Phase 2 study testing Syntocinon in people with Frontotemporal Dementia, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 11 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. 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?
Syntocinon
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
11 sitesin 2 countries
Study dates
31 Jan 2018to 31 Dec 2024
Phase
Phase 2
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

  • 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).

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

11 sites in 2 countries.

11 sites in 2 countries

Canada6 sites

  • Parkwood Institute

    London, Ontario, N6C 0A7

  • Montreal Neurological Institute and Hospital

    Montreal, Quebec

  • Laval University

    Québec, G1J1Z4

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario

  • University Health Network

    Toronto, Ontario

  • University of British Columbia

    Vancouver, British Columbia

Other trials in Canada

United States5 sites

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224

  • UCLA

    Los Angeles, California, 90095

  • Columbia University Medical Center

    New York, New York, 10032

  • University of California, San Francisco

    San Francisco, California, 94158

  • University of Washington

    Seattle, Washington, 98195

Other trials in United States

About this study

Official title: 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.

Being tested
Syntocinon
Keywords
oxytocin, frontotemporal dementia, apathy, empathy
Medical subject headings
Frontotemporal Dementia, Lethargy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SyntocinonDrug

    Also called Intranasal Oxytocin

    Intranasal Oxytocin

Study groups in NCT03260920
Study groupRoleWhat they receive
Low DoseExperimentalNot described
Receives: Drug: Syntocinon
Medium DoseExperimentalNot described
Receives: Drug: Syntocinon
High DoseExperimentalNot described
Receives: Drug: Syntocinon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 20 weeks

Secondary outcomes (3)

  1. Change in emotional facial expression recognition performance

    Measured: Up to 20 weeks

  2. Change in the Revised Self-Monitoring Scale score

    Measured: Up to 20 weeks

  3. Change in modified Clinicians Global Impression of Change (apathy) scores

    Measured: Up to 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2017
  2. Study start31 Jan 2018
  3. Primary completion30 Jun 2023
  4. Study completion31 Dec 2024 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
A Proof-of-Concept Double Blind Randomized Controlled, Cross-Over Adaptive Design Trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03260920
Sponsor's protocol ID
FTDOXY17EF
Acronym
FOXY
Status last verified
Nov 2023
First submitted
19 Jul 2017
Last updated
15 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Coleman KKL, Berry S, Cummings J, Hsiung GR, Laforce R, Huey E, Ducharme S, Tartaglia MC, Mendez MF, Onyike C, Domoto-Reilly K, Masellis M, Herrmann N, Porsteinsson A, Detry MA, Stewart C, Bosse AL, McGlothlin A, Dias B, Pandey S, Mayich M, Pasternak SH, Ruiz Garcia R, Restrepo-Martinez M, Feldman H, Boxer AL, Finger EC. Intranasal oxytocin for apathy in people with frontotemporal dementia (FOXY): a multicentre, randomised, double-blind, placebo-controlled, adaptive, crossover, phase 2a/2b superiority trial. Lancet Neurol. 2025 Feb;24(2):128-139. doi: 10.1016/S1474-4422(24)00456-3.

    PubMed 39862881

  • 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.

    PubMed 30261917

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Syntocinon in people with Frontotemporal Dementia, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 11 sites in 2 countries.

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 7 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Canada, United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Change in Neuropsychiatric Inventory (NPI) apathy/indifference domain score (time frame: Up to 20 weeks). 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 NCT03260920, which also lists 2 linked publications.

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 15 Dec 2023.

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