TerminatedPhase 2

Intranasal Insulin in Frontotemporal Dementia (FTD)

Stopped: COVID - unable to restart after restrictions were lifted

United States3 participantsStarted 2019-09-09

Plain-language 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.

Who can participate

Age range41 Years – 89 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

What they're measuring

Feasibility Measured by EXAMINER Battery

Timeframe: Baseline and Post Treatment

Feasibility Measured by Recruitment

Timeframe: Baseline

Safety Measured by Total Serious Adverse Events (SAEs) and Adverse Events (AEs)

Timeframe: 2 months

Trial details

NCT IDNCT04115384

SponsorHealthPartners Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-26

Results submitted2023-06-14

View on ClinicalTrials.gov More Frontotemporal Dementia, Behavioral Variant trials