Intranasal Insulin in Frontotemporal Dementia (FTD)

NCT04115384 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: A18-305
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Frontotemporal Dementia, Behavioral Variant

Keywords

intranasal; insulin

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• Feasibility Measured by Completion of Study

  2 months

• Feasibility Measured by Screen Fails

  2 years

• Safety Measured by Unique Subjects With Serious Adverse Events (SAEs) and Adverse Events (AEs)

  4 weeks

Other Outcomes (9)

• Pre to Post Working Memory Measured by EXAMINER - Dot Counting

  4 weeks

• Pre to Post Verbal Fluency Measured by EXAMINER - Animal Fluency

  4 weeks

• Pre to Post Inhibition by EXAMINER - Flanker

  4 weeks

Study Arms (1)

Insulin (Novolin-R)

EXPERIMENTAL

Regular insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril) BID

Drug: Novolin-R insulin

Interventions

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.

Also known as: insulin, Novolin-R

Insulin (Novolin-R)

Eligibility Criteria

• Age: 41 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Subject has a Mini-Mental State Exam (MMSE) score ≥18.
• Subject is \> 40 and \<90 years of age.
• Female subjects are post-menopausal or have a negative pregnancy test
• The subject must be proficient in speaking, reading and understanding English in order to comply with procedural testing of cognitive function, memory and physiology.
• Subject has a dedicated family member/caregiver, who will be able to attend all visits and report on subject's status.
• 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.
• Subject must have undergone a brain computed tomography (CT) scan or magnetic resonance imaging (MRI) scan as part of receiving frontotemporal dementia (FTD) diagnosis

You may not qualify if:

• 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.
• Subject has medical history and/or clinically determined disorders: current B12 deficiency, chronic sinusitis, untreated thyroid disease, or significant head trauma.
• Subject has had previous nasal and/or oto-pharyngeal surgery and severe deviated septum and/or other anomalies.
• Subject has a history of any psychiatric illness that would pose a safety risk to the subject as determined by investigator.
• Subject is currently taking any medications (anticholinergics, antihistamines, benzodiazepines, barbiturates, or insulin) that are clinically contraindicated as determined by investigator.
• Subject has undergone a recent change (\<1 month) in their selective serotonin reuptake inhibitors (SSRI) or anti-depressant medication.
• 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).
• The subject has participated in a clinical trial investigation within 1 month of this study.
• The subject has an insulin allergy.

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

Location

MeSH Terms

Conditions

Pick Disease of the Brain; Insulin Resistance

Interventions

Insulin

Condition Hierarchy (Ancestors)

Frontotemporal Dementia; Frontotemporal Lobar Degeneration; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Manager Research Operations
• Organization: HealthPartners Institute

ClinicalTrials@HealthPartners.com

651-495-6363

Study Officials

• Michael H Rosenbloom, MD

  HealthPartners Neurology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 4, 2019
• Study Start: September 9, 2019
• Primary Completion: February 26, 2020
• Study Completion: May 15, 2023
• Last Updated: October 27, 2023
• Results First Posted: July 6, 2023

Record last verified: 2023-04

Locations

US (1)