Intranasal Insulin in Frontotemporal Dementia (FTD)
Condition: Frontotemporal Dementia, Behavioral Variant
MeSH terms: Dementia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
Intervention: Novolin-R insulin
Intervention description: Insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril), twice per day, once in the morning and again in the evening (at least 8 hours between doses) for 4 weeks.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 41 Years
Maximum age: 89 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: intranasal; insulin

Summary:

      This project will study intranasal (IN) insulin in Frontotemporal dementia (FTD) in 12
      patients. Study Investigators aim to evaluate the feasibility of the EXAMINER cognitive
      battery as a cognitive outcome measure in FTD, the ability of the HealthPartners Center for
      Memory and Aging's ability to sufficiently recruit subjects with FTD, and the safety of IN
      regular insulin administered 20 IU twice per day in two specific variants of FTD (behavioral
      variant frontotemporal dementia (bv-FTD), semantic dementia (SD)) over a 4 week period.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subject meeting international consensus criteria for probable
             behavioral variant frontotemporal dementia or criteria for semantic dementia
             (Gorno-Tempini et al., 2011; Rascovsky et al., 2011)

          2. Subject has a Mini-Mental State Exam (MMSE) score ≥18.

          3. Subject is > 40 and <90 years of age.

          4. Female subjects are post-menopausal or have a negative pregnancy test

          5. The subject must be proficient in speaking, reading and understanding English in order
             to comply with procedural testing of cognitive function, memory and physiology.

          6. Subject has a dedicated family member/caregiver, who will be able to attend all visits
             and report on subject's status.

          7. Subject and family member/caregiver have both provided fully informed written consent
             prior to participation. In the event that subject is legally unable to provide
             informed written consent due to deterioration in cognitive abilities, fully informed
             written consent must be provided by a legally authorized representative.

          8. Subject must have undergone a brain computed tomography (CT) scan or magnetic
             resonance imaging (MRI) scan as part of receiving frontotemporal dementia (FTD)
             diagnosis

        Exclusion Criteria:

          1. Subject has medical history and/or clinically determined evidence of other central
             nervous system (CNS) disorders including, but not limited to brain tumor, active
             subdural hematoma, seizure disorder, multiple sclerosis, Alzheimer's disease, vascular
             dementia, corticobasal syndrome, progressive supranuclear palsy, Parkinson's disease,
             multiple system atrophy, Lewy body dementia, normal pressure hydrocephalus,
             Huntington's disease, or Jakob-Creutzfeldt disease presenting as dementia.

          2. Subject has medical history and/or clinically determined disorders: current B12
             deficiency, chronic sinusitis, untreated thyroid disease, or significant head trauma.

          3. Subject has history of any of the following: moderate to severe pulmonary disease,
             poorly controlled congestive heart failure, significant cardiovascular and/or
             cerebrovascular events within previous 6 months, condition known to affect absorption,
             distribution, metabolism, or excretion of drugs such as any hepatic, renal or
             gastrointestinal disease or any other clinically relevant abnormality that inclusion
             would pose a safety risk to the subject as determined by investigator.

          4. Subject has had previous nasal and/or oto-pharyngeal surgery and severe deviated
             septum and/or other anomalies.

          5. Subject has a history of any psychiatric illness that would pose a safety risk to the
             subject as determined by investigator.

          6. Subject is currently taking any medications (anticholinergics, antihistamines,
             benzodiazepines, barbiturates, or insulin) that are clinically contraindicated as
             determined by investigator.

          7. Subject has undergone a recent change (<1 month) in their selective serotonin reuptake
             inhibitors (SSRI) or anti-depressant medication.

          8. Subject has current or recent drug or alcohol abuse or dependence as defined by the
             Diagnostic and Statistical Manual of Mental Disorders 5, Text Revision (DSM-IV TR).

          9. Screening laboratory results that are medically relevant, in which inclusion would
             pose a safety risk to the subject as determined by investigator.

         10. The subject has participated in a clinical trial investigation within 1 month of this
             study.

         11. The subject has an insulin allergy.