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FTDOXY10EF

CompletedPhase 1

Safety Study of Intranasal Oxytocin in Frontotemporal Dementia

A Phase I Dose Finding Study of Intranasal Oxytocin in Frontotemporal Dementia, Protocol # FTDOXY10EF

Asset

Oxytocin

Listed sites

1

Recruiting sites

-

Enrollment

23

actual

Study population

Frontotemporal dementia

Key I/E criteria

•Symptomatic FTD•Study partner/caregiver required

Primary endpoint

•Adverse Events as a Measure of Safety and Tolerability

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Secondary ID17783REB
NCT IDNCT01386333
Org study IDR-11-232

Timeline

Milestones

Study start2011-06 (month precision)
Study first posted2011-07-01estimated
Primary completion2013-10actual (month precision)
Last update posted2013-11-04estimated

Assets

Drug assets

Oxytocin

Study populations

Who this study enrolls

Frontotemporal dementia

Eligibility

Who can enroll

Minimum age30 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•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

Exclusion criteria

•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.

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
4
Global cognition
1
Behavior / neuropsychiatric
1
Safety / tolerability / PK
1

Global cognition

1 endpoint
Secondary/protocol endpoint

Clinical Dementia Rating- Frontotemporal Lobar Degeneration

Time frame:1 week

ratio, descriptive

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Neuropsychiatric Inventory

Time frame:1 week

Neuropsychiatric Inventory (NPI)

descriptive

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Time frame:2 week

event count, event

Other (unclassified)

4 endpoints
Secondary/protocol endpoint/low confidence

Frontal Behavioural Inventory

Time frame:1 week

descriptive

Secondary/protocol endpoint/low confidence

Clinicians Global Impression of Change

Time frame:1 week

descriptive

Secondary/protocol endpoint/low confidence

Interpersonal Reactivity Index

Time frame:1 week

descriptive

Secondary/protocol endpoint/low confidence

Multi-faceted Empathy Test

Time frame:1 week

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.