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.
Frontotemporal dementia (FTD) with its multiple pathological manifestations, is a disease that results in progressive deterioration of social comportment, executive function, and language. Despite the debilitating nature of FTD and the relatively high prevalence in the younger patient population, available pharmacological interventions are limited to symptomatic treatments. There are no therapeutic agents that have been developed that specifically treat the progressive cognitive symptoms of FTD. This project will study IN insulin in FTD in 12 patients. 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 Center'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. Frontotemporal dementia (FTD) with its multiple pathological manifestations, is a disease that results in progressive deterioration of social comportment, executive function, and language. Despite the debilitating nature of FTD and the relatively high prevalence in the younger patient population, available pharmacological interventions are limited to symptomatic treatments. There are no therapeutic agents that have been developed that specifically treat the progressive cognitive symptoms of FTD.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
3
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.
HealthPartners Neuroscience Center
Saint Paul, Minnesota, United States
Feasibility Measured by EXAMINER Battery
Number of patients completing the entire EXAMINER battery. Range: 0-3. More participants completing EXAMINER indicates higher feasibility.
Time frame: Baseline and Post Treatment
Feasibility Measured by Recruitment
Number of patients enrolled in this study. Range: 0-12. More participants enrolling indicates higher feasibility.
Time frame: Baseline
Safety Measured by Total Serious Adverse Events (SAEs) and Adverse Events (AEs)
Total number of AEs/SAEs during the course of treatment. More AEs/SAEs indicates a less safe treatment.
Time frame: 2 months
Feasibility Measured by Completion of Study
Number of patients completing the entire study. Range: 0-12. More participants completing the study indicates higher feasibility.
Time frame: 2 months
Feasibility Measured by Screen Fails
Number of patients screen failing during the study. More participants screen failing the study indicates lower feasibility.
Time frame: 2 years
Safety Measured by Unique Subjects With Serious Adverse Events (SAEs) and Adverse Events (AEs)
Total number of unique participants experiencing AEs/SAEs during the course of treatment. More unique participants experiencing AEs/SAEs indicates a less safe treatment.
Time frame: 4 weeks
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