Frontotemporal dementia (bvFTD) MedDRA version: 21.1 Level: PT Classification code 10068968 Term: Frontotemporal dementia System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Pharmaceutical Form: Nasal spray
INN or Proposed INN: OSSITOCINA
Current Sponsor code: Syntocinon
Other descriptive name: Syntocinon
Concentration unit: IU/ml international unit(s)/millilitre
Concentr
Sponsors
ALMA MATER STUDIORUM UNIVERSITà DI BOLOGNA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - diagnosis of possible and probable behavioral variant FTD (bvFTD) based on clinical assessment, standard neuropsychological, functional, and neurobehavioral tests; - early and mild bvFTD (MMSE score=20); - stable (i.e., more than 2 months) medical treatment related to cognition or behaviour traditionally used for bvFTD, such as acetylcholinesterase inhibitors, memantine, anti-depressants, antipsychotic agents, other mood stabilizers, benzodiazepines. - ages 40-80; - both genders (women in menopausal status: females with amenorrhea for 12 months without an alternative medical cause. A high follicle stimulating hormone, FSH, level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy) - Males participants with female premenopausal partners must agree to use a double barrier method of contraception i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam, and agree to maintain this throughout the study. Oxytocin nasal sprays has not been studied in pregnant or lactating women. - normal or correct-to normal vision - to be able to read and understand Italian language (the language used for the study instructions and Consent Form); - to be able to sign the consent form (MMSE=20, the semantic fluency, TMT A-B, and Digit Span scores should not be below 2SD from the mean scores); - availability of a caregiver who consents to participate into all study sessions and complete specific tests. (We consider a caregiver the person who spends at least 8 hours a day with the patient). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 52 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: - Severe bvFTD (MMSE 100 bpm) - Current hyponatremia (Na <135 mEq/L) - Psychiatric disorders (depression, bipolar disorder or schizophrenia) - Hormonal therapy - Premenopausal women - Males refusing to use a double barrier method of contraception throughout the study. - Abuse of alcohol and drugs during the last 6 months - Severe hepatic or renal impairment - Ischemic cardiomyopathy - Diagnosis of cancer not in remission since at least 10 years - Known allergy to food additive and preservatives used for nasal sprays (E 216, E 218 and chlorobutanol hemihydrate) - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary goal is to investigate whether acute intranasal administration of oxytocin improves social cognition performances in bvFTD patients, as detected using experimental tasks. 1. Change from placebo condition in emotion recognition ability [ Time Frame: within two hours after IMP-1/IMP-2 administration, single-measurement/treatment (total of observations: 2)] 2. Change from placebo condition in empathy ability [ Time Frame: within two hours after IMP-1/IMP-2 administration, single-measurement/treatment (total of observations: 2)] 3. Change from placebo condition in time perception [ Time Frame: within two hours after IMP-1/IMP-2 administration, each testing day (total of observations: 4)];Secondary Objective: The secondary goals are detecting whether oxytocin administration induces side effects and mood changes, as detected by participant’s and caregiver’s reports, and whether oxytocin’s effects depend on gender and/or number of administrations. In addition, we aim to monitor the changes of peripheral oxytocin levels following intranasal oxytocin administration. 1. Change from placebo condition in self-reported side effects associatedwithrepeatedacute administrationofoxytocin 2. Change from placebo condition in Caregiver’s rating of patient’s side effects and mood change associated with repeated acute administration of oxytocin 3. Change from placebo condition in variation of oxytocin peripheral levels associated with acute administration of oxytocin 4. Change from placebo condition in variation of gender-related behavioral differences associated with acute administration of oxytocin;Primary end point(s): On each testing day, in the 2 hr following substance administration, oxytocin induces a 20% improvement of social cognition performances in the context of a placebo-controlled trial: • Increased accuracy (number of corrected responses) and decreased latency (speed in ms to provide responses) to recognize emotions on the emotion recognition ta | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): With respect to the secondary measures, we anticipate the following endpoints: • No difference between oxytocin and placebo with respect to frequency of sides effects indicated by the participant on a checklist on each testing day • Increase of positive affect as reported by the caregiver. • Increase of peripheral oxytocin concentration after oxytocin treatment • Stronger effect of oxytocin in males than females (because the levels are lower in baseline) Regarding the measurement of oxytocin concentrations, before and after the IMP administration, patients’ 9 ml blood samples will be collected and analyzed using the high-performance liquid chromatography method. The blood collection is a moderate-painful and relatively low-intrusive procedure. The blood sample will be collected by expert nurses 10 minutes before the IMP administration and at the end of the first experimental da;Timepoint(s) of evaluation of this end point: Day 7, 14, 21, 28 | — |
Countries
Italy
Contacts
Public ContactDIMEC
Università di Bologna
Outcome results
None listed