Intranasal Insulin in Frontotemporal Dementia (FTD)

• Register: ClinicalTrials.gov
• Last refreshed on: 6 November 2023
• Main ID: NCT04115384
• Date of registration: 02/10/2019
• Prospective Registration: No
• Primary sponsor: HealthPartners Institute
• Public title: Intranasal Insulin in Frontotemporal Dementia (FTD)
• Scientific title: A Single Center Feasibility Study of Intranasal Insulin in Frontotemporal Dementia NIFT-D
• Date of first enrolment: September 9, 2019
• Target sample size: 3
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT04115384
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Michael H Rosenbloom, MD
• Affiliation: HealthPartners Neurology

Key inclusion & exclusion 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.



Age minimum: 41 Years
Age maximum: 89 Years
Gender: All

Health Condition(s) or Problem(s) studied

Frontotemporal Dementia, Behavioral Variant

Intervention(s)

Drug: Novolin-R insulin

Primary Outcome(s)

Feasibility Measured by Recruitment [Time Frame: Baseline]

Safety Measured by Total Serious Adverse Events (SAEs) and Adverse Events (AEs) [Time Frame: 2 months]

Feasibility Measured by EXAMINER Battery [Time Frame: Baseline and Post Treatment]

Secondary Outcome(s)

Safety Measured by Unique Subjects With Serious Adverse Events (SAEs) and Adverse Events (AEs) [Time Frame: 4 weeks]

Feasibility Measured by Completion of Study [Time Frame: 2 months]

Feasibility Measured by Screen Fails [Time Frame: 2 years]

Secondary ID(s)

A18-305

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/07/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT04115384