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Insulin
Insulin (Novolin-R) for Frontotemporal Dementia
Phase 2
Waitlist Available
Led By Michael H Rosenbloom, MD
Research Sponsored by HealthPartners Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will study intranasal insulin in patients with Frontotemporal dementia, in order to evaluate the feasibility of the EXAMINER cognitive battery, the ability to recruit subjects, and the safety of intranasal regular insulin administered 20 IU twice per day.
Eligible Conditions
- Frontotemporal Dementia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility Measured by EXAMINER Battery
Feasibility Measured by Recruitment
Safety Measured by Total Serious Adverse Events (SAEs) and Adverse Events (AEs)
Secondary outcome measures
Feasibility Measured by Completion of Study
Feasibility Measured by Screen Fails
Safety Measured by Unique Subjects With Serious Adverse Events (SAEs) and Adverse Events (AEs)
Other outcome measures
Pre to Post Appetite Changes by the Appetite and Eating Habit Questionnaire (APEHQ) - Appetite Subscore
Pre to Post Appetite Changes by the Appetite and Eating Habit Questionnaire (APEHQ) - Eating Habits Subscore
Pre to Post Appetite Changes by the Appetite and Eating Habit Questionnaire (APEHQ) - Food Preference Subscore
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Insulin (Novolin-R)Experimental Treatment1 Intervention
Regular insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril) BID
Find a Location
Who is running the clinical trial?
HealthPartners InstituteLead Sponsor
186 Previous Clinical Trials
3,661,438 Total Patients Enrolled
2 Trials studying Frontotemporal Dementia
2,553 Patients Enrolled for Frontotemporal Dementia
Michael H Rosenbloom, MDPrincipal InvestigatorHealthPartners Neurology
8 Previous Clinical Trials
228 Total Patients Enrolled
1 Trials studying Frontotemporal Dementia
3 Patients Enrolled for Frontotemporal Dementia
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