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Intranasal Insulin in Frontotemporal Dementia (FTD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04115384
Recruitment Status : Recruiting
First Posted : October 4, 2019
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
HealthPartners Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Frontotemporal Dementia, Behavioral Variant Drug: Novolin-R insulin Phase 2

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Single Center Feasibility Study of Intranasal Insulin in Frontotemporal Dementia NIFT-D
Actual Study Start Date : September 9, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : November 2020


Arm Intervention/treatment
Experimental: Insulin (Novolin-R)
Regular insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril) BID
Drug: 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.
Other Name: insulin, Novolin-R




Primary Outcome Measures :
  1. Feasibility measured by EXAMINER battery [ Time Frame: 2 years ]
    Number of patients completing the entire EXAMINER battery. Range: 0-12. More participants completing EXAMINER indicates higher feasibility.

  2. Feasibility measured by recruitment [ Time Frame: 2 years ]
    Number of patients enrolled in this study. Range: 0-12. More participants enrolling indicates higher feasibility.

  3. Safety measured by total serious adverse events (SAEs) and adverse events (AEs) [ Time Frame: 4 weeks ]
    Total number of AEs/SAEs during the course of treatment. More AEs/SAEs indicates a less safe treatment.


Secondary Outcome Measures :
  1. Feasibility measured by completion of study [ Time Frame: 2 years ]
    Number of patients completing the entire study. Range: 0-12. More participants completing the study indicates higher feasibility.

  2. Feasibility measured by screen fails [ Time Frame: 2 years ]
    Number of patients screen failing during the study. More participants screen failing the study indicates lower feasibility.

  3. Safety measured by unique subjects with serious adverse events (SAEs) and adverse events (AEs) [ Time Frame: 4 weeks ]
    Total number of unique participants experiencing AEs/SAEs during the course of treatment. More unique participants experiencing AEs/SAEs indicates a less safe treatment.


Other Outcome Measures:
  1. Pre to Post working memory measured by EXAMINER - dot counting [ Time Frame: 4 weeks ]
    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.

  2. Pre to Post verbal fluency measured by EXAMINER - animal fluency [ Time Frame: 4 weeks ]
    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.

  3. Pre to Post inhibition by EXAMINER - flanker [ Time Frame: 4 weeks ]
    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. Pre to Post inhibition by EXAMINER - set shifting [ Time Frame: 4 weeks ]
    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.

  5. Pre to Post appetite changes by the appetite and eating habit questionnaire (APEHQ) - Swallowing subscore [ Time Frame: 4 weeks ]
    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.

  6. Pre to Post appetite changes by the appetite and eating habit questionnaire (APEHQ) - Appetite subscore [ Time Frame: 4 weeks ]
    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.

  7. Pre to Post appetite changes by the appetite and eating habit questionnaire (APEHQ) - Eating Habits subscore [ Time Frame: 4 weeks ]
    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.

  8. Pre to Post appetite changes by the appetite and eating habit questionnaire (APEHQ) - Food Preference subscore [ Time Frame: 4 weeks ]
    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.

  9. Pre to Post appetite changes by the appetite and eating habit questionnaire (APEHQ) - Other Oral Behaviors subscore [ Time Frame: 4 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   41 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04115384


Contacts
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Contact: Maria Pyle 651-495-6363 Maria.X.Pyle@HealthPartners.com
Contact: Sharon Hwee 651-495-6363 Sharon.X.Hwee@HealthPartners.com

Locations
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United States, Minnesota
HealthPartners Neuroscience Center Recruiting
Saint Paul, Minnesota, United States, 55130
Contact: Clinical Trial Coordinator    651-495-6363      
Sponsors and Collaborators
HealthPartners Institute
Investigators
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Principal Investigator: Michael H Rosenbloom, MD HealthPartners Neurology
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Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT04115384    
Other Study ID Numbers: A18-305
First Posted: October 4, 2019    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HealthPartners Institute:
intranasal
insulin
Additional relevant MeSH terms:
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Dementia
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Neurodegenerative Diseases
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs