Safety Study of Intranasal Oxytocin in Frontotemporal Dementia

NCT01386333 | Completed Phase 1

• 2 other identifiers: R-11-23217783
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Frontotemporal Dementia; oxytocin; Pick's disease

Outcome Measures

Primary Outcomes (1)

• 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.

  2 week

Secondary Outcomes (6)

• Neuropsychiatric Inventory

  1 week

• Frontal Behavioural Inventory

  1 week

• Clinicians Global Impression of Change

  1 week

• Clinical Dementia Rating- Frontotemporal Lobar Degeneration

  1 week

• Interpersonal Reactivity Index

  1 week

Study Arms (4)

Oxytocin 24IU

EXPERIMENTAL

Oxytocin 24 IU administered intranasally twice daily for 1 week

Drug: oxytocin

Oxytocin 48 IU

EXPERIMENTAL

48 IU of intranasal oxytocin administered twice daily for 1 week

Drug: oxytocin

72 IU oxytocin

EXPERIMENTAL

72 IU of intranasal oxytocin administered twice daily for 1 week

Drug: oxytocin

Saline nasal spray

PLACEBO COMPARATOR

Drug: oxytocin; Drug: Saline Nasal Mist

Interventions

oxytocin DRUG

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

72 IU oxytocin; Oxytocin 24IU; Oxytocin 48 IU; Saline nasal spray

Saline Nasal Mist DRUG

Placebo arm wil receive saline nasal mist sprays matched in number to oxytocin dose cohorts

Saline nasal spray

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Consortium of Canadian Centres for Clinical Cognitive Research: collaborator

Study Sites (1)

Cognitive Neurology and Alzheimer Research Centre

London, Ontario, N6A 4V2, Canada

Location

Related Publications (1)

• 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.

  PMID: 25503617 DERIVED

MeSH Terms

Conditions

Frontotemporal Dementia; Pick Disease of the Brain

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Frontotemporal Lobar Degeneration; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; TDP-43 Proteinopathies; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Elizabeth C Finger, MD

  University of Western Ontario, Lawson Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cognitive Neurologist

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: July 1, 2011
• Study Start: June 1, 2011
• Primary Completion: October 1, 2013
• Last Updated: November 4, 2013

Record last verified: 2013-11

Locations

CA (1)