Study of Nasal Insulin to Fight Forgetfulness - Device Study
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 20
Summary
- Conditions
- Cognitive Impairment
- Mild Cognitive Impairment
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: At study entry, participants will be randomized to receive either an acute dose of insulin or of placebo first and the other substance on a second visit.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Neither participants or site personnel will know whether insulin or saline is being administered. Exceptions will be the study nurse who is directly involved in preparing the insulin or placebo, as well as preparing DSMB reports.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 55 years and 85 years
- Gender
- Both males and females
Description
The aim of this study is to determine the ability of an intranasal delivery device to increase levels of insulin in cerebrospinal fluid (CSF). A growing body of evidence suggests that insulin plays a role in normal memory processes and that insulin abnormalities may contribute to cognitive and brain...
The aim of this study is to determine the ability of an intranasal delivery device to increase levels of insulin in cerebrospinal fluid (CSF). A growing body of evidence suggests that insulin plays a role in normal memory processes and that insulin abnormalities may contribute to cognitive and brain changes associated with Alzheimer's disease (AD). Interestingly, insulin administered to the nasal cavity is transported within a few minutes into the brain, but does not affect blood sugar or insulin levels. The study will consist of a single site, randomized, double-blind trial comparing the acute effects of INI (20 International Units) or placebo delivered with nebulizer-like device on CSF insulin levels, AD biomarkers and memory. At study entry, participants will be randomized to receive either an acute dose of insulin or placebo first, and the other substance on a second visit. Participants who are cognitively normal or who have aMCI (n=20) will be enrolled. The primary outcome measure will be to test the hypothesis that CSF insulin levels will increase 30 minutes after receiving a 20 International Units dose of insulin delivered with a nebulizer-like device, compared to levels achieved 30 minutes after placebo.
Tracking Information
- NCT #
- NCT03857321
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Suzanne Craft, PhD Wake Forest University Health Sciences