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COVID - unable to restart after restrictions were lifted
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin (Novolin-R) | Experimental | Regular insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril) BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novolin-R insulin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility Measured by EXAMINER Battery | Number of patients completing the entire EXAMINER battery. Range: 0-3. More participants completing EXAMINER indicates higher feasibility. | Baseline and Post Treatment |
| Feasibility Measured by Recruitment | Number of patients enrolled in this study. Range: 0-12. More participants enrolling indicates higher feasibility. | 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. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility Measured by Completion of Study | Number of patients completing the entire study. Range: 0-12. More participants completing the study indicates higher feasibility. | 2 months |
| Feasibility Measured by Screen Fails |
| Measure | Description | Time Frame |
|---|---|---|
| Pre to Post Working Memory Measured by EXAMINER - Dot Counting | Dot counting measures verbal working memory. Participants are asked to count colored shapes on a tables and remember the final total over 6 trials. Scores are totaled as the number of correct answers or the number of answers recalled. Range: 0-27. A higher score indicates better performance. | 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael H Rosenbloom, MD | HealthPartners Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthPartners Neuroscience Center | Saint Paul | Minnesota | 55130 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin (Novolin-R) | Regular insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril) BID Novolin-R insulin: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Insulin (Novolin-R) | Regular insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril) BID Novolin-R insulin: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility Measured by EXAMINER Battery | Number of patients completing the entire EXAMINER battery. Range: 0-3. More participants completing EXAMINER indicates higher feasibility. | Posted | Count of Participants | Participants | Baseline and Post Treatment |
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2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Insulin (Novolin-R) | Regular insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril) BID Novolin-R insulin: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coughing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Persistent coughing |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager Research Operations | HealthPartners Institute | 651-495-6363 | ClinicalTrials@HealthPartners.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 27, 2019 | May 17, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020774 | Pick Disease of the Brain |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D057180 | Frontotemporal Dementia |
| D057174 | Frontotemporal Lobar Degeneration |
| D003704 | Dementia |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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Number of patients screen failing during the study. More participants screen failing the study indicates lower feasibility.
| 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. | 4 weeks |
| Pre to Post Verbal Fluency Measured by EXAMINER - Animal Fluency | Participants are asked to name as many animals as he/she can in 60 seconds. Scores are totaled as the number of animals verbalized. A higher score indicates better performance. | 4 weeks |
| Pre to Post Inhibition by EXAMINER - Flanker | Participants are asked to choose the direction of one the center arrow in a group 5 arrows. Range: 0- 10. This is a global score that combines accuracy and reaction time. A higher score indicates better performance. | 4 weeks |
| Pre to Post Inhibition by EXAMINER - Set Shifting | Participants are asked to match stimulus on different parts of a tablet screen. Range: 0- 10. This is a global score that combines accuracy and reaction time. A higher score indicates better performance. | 4 weeks |
| Pre to Post Appetite Changes by the Appetite and Eating Habit Questionnaire (APEHQ) - Swallowing Subscore | A survey about changes in eating behaviors. The sum of frequency times severity of swallowing related questions is the score for this portion. Caregivers of participant are asked to fill this survey out. Range: 0-96. Higher scores indicate higher difficulty swallowing that produces conflict or embarrassment. | 4 weeks |
| Pre to Post Appetite Changes by the Appetite and Eating Habit Questionnaire (APEHQ) - Appetite Subscore | A survey about changes in eating behaviors. The sum of frequency times severity of appetite related questions is the score for this portion. Caregivers of participant are asked to fill this survey out Range: 0-96. Higher scores indicate a greater change in appetite that produces conflict or embarrassment. | 4 weeks |
| Pre to Post Appetite Changes by the Appetite and Eating Habit Questionnaire (APEHQ) - Eating Habits Subscore | A survey about changes in eating behaviors. The sum of frequency times severity of eating habit related questions is the score for this portion. Caregivers of participant are asked to fill this survey out Range: 0-72. Higher scores indicate a greater change in eating habits that produces conflict or embarrassment. | 4 weeks |
| Pre to Post Appetite Changes by the Appetite and Eating Habit Questionnaire (APEHQ) - Food Preference Subscore | A survey about changes in eating behaviors. The sum of frequency times severity of food preference related questions is the score for this portion. Caregivers of participant are asked to fill this survey out Range: 0-84. Higher scores indicate a greater change in food preferences that produces conflict or embarrassment. | 4 weeks |
| Pre to Post Appetite Changes by the Appetite and Eating Habit Questionnaire (APEHQ) - Other Oral Behaviors Subscore | A survey about changes in eating behaviors. The sum of frequency times severity of other oral behavior related questions is the score for this portion. Caregivers of participant are asked to fill this survey out Range: 0-60. Higher scores indicate a greater changes that produces conflict or embarrassment. | 4 weeks |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Feasibility Measured by Recruitment | Number of patients enrolled in this study. Range: 0-12. More participants enrolling indicates higher feasibility. | The original goal was to include 12 participants. Since this is a feasibility outcome, the analysis population is the original goal total. | Posted | Count of Participants | Participants | Baseline |
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| Primary | 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. | Posted | Number | Total number of AEs/SAEs reported | 2 months |
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| Secondary | Feasibility Measured by Completion of Study | Number of patients completing the entire study. Range: 0-12. More participants completing the study indicates higher feasibility. | 12 participants were expected. Only 3 participants were able to complete the trial | Posted | Count of Participants | Participants | 2 months |
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| Secondary | Feasibility Measured by Screen Fails | Number of patients screen failing during the study. More participants screen failing the study indicates lower feasibility. | Posted | Count of Participants | Participants | 2 years |
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| Secondary | 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. | Posted | Count of Participants | Participants | 4 weeks |
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| Other Pre-specified | Pre to Post Working Memory Measured by EXAMINER - Dot Counting | Dot counting measures verbal working memory. Participants are asked to count colored shapes on a tables and remember the final total over 6 trials. Scores are totaled as the number of correct answers or the number of answers recalled. Range: 0-27. A higher score indicates better performance. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
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| Other Pre-specified | Pre to Post Verbal Fluency Measured by EXAMINER - Animal Fluency | Participants are asked to name as many animals as he/she can in 60 seconds. Scores are totaled as the number of animals verbalized. A higher score indicates better performance. | Posted | Mean | Standard Deviation | named animals | 4 weeks |
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| Other Pre-specified | Pre to Post Inhibition by EXAMINER - Flanker | Participants are asked to choose the direction of one the center arrow in a group 5 arrows. Range: 0- 10. This is a global score that combines accuracy and reaction time. A higher score indicates better performance. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
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| Other Pre-specified | Pre to Post Inhibition by EXAMINER - Set Shifting | Participants are asked to match stimulus on different parts of a tablet screen. Range: 0- 10. This is a global score that combines accuracy and reaction time. A higher score indicates better performance. | Posted | Mean | Standard Deviation | change is score on a scale | 4 weeks |
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| Other Pre-specified | Pre to Post Appetite Changes by the Appetite and Eating Habit Questionnaire (APEHQ) - Swallowing Subscore | A survey about changes in eating behaviors. The sum of frequency times severity of swallowing related questions is the score for this portion. Caregivers of participant are asked to fill this survey out. Range: 0-96. Higher scores indicate higher difficulty swallowing that produces conflict or embarrassment. | Posted | Mean | Standard Deviation | change in score on a scale | 4 weeks |
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| Other Pre-specified | Pre to Post Appetite Changes by the Appetite and Eating Habit Questionnaire (APEHQ) - Appetite Subscore | A survey about changes in eating behaviors. The sum of frequency times severity of appetite related questions is the score for this portion. Caregivers of participant are asked to fill this survey out Range: 0-96. Higher scores indicate a greater change in appetite that produces conflict or embarrassment. | Posted | Mean | Standard Deviation | change in score on a scale | 4 weeks |
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| Other Pre-specified | Pre to Post Appetite Changes by the Appetite and Eating Habit Questionnaire (APEHQ) - Eating Habits Subscore | A survey about changes in eating behaviors. The sum of frequency times severity of eating habit related questions is the score for this portion. Caregivers of participant are asked to fill this survey out Range: 0-72. Higher scores indicate a greater change in eating habits that produces conflict or embarrassment. | Posted | Mean | Standard Deviation | change in score on a scale | 4 weeks |
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| Other Pre-specified | Pre to Post Appetite Changes by the Appetite and Eating Habit Questionnaire (APEHQ) - Food Preference Subscore | A survey about changes in eating behaviors. The sum of frequency times severity of food preference related questions is the score for this portion. Caregivers of participant are asked to fill this survey out Range: 0-84. Higher scores indicate a greater change in food preferences that produces conflict or embarrassment. | Posted | Mean | Standard Deviation | change in score on a scale | 4 weeks |
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| Other Pre-specified | Pre to Post Appetite Changes by the Appetite and Eating Habit Questionnaire (APEHQ) - Other Oral Behaviors Subscore | A survey about changes in eating behaviors. The sum of frequency times severity of other oral behavior related questions is the score for this portion. Caregivers of participant are asked to fill this survey out Range: 0-60. Higher scores indicate a greater changes that produces conflict or embarrassment. | Posted | Mean | Standard Deviation | change in score on a scale | 4 weeks |
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| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |