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Clinical Trials/NCT00581867
NCT00581867
Completed
Phase 1

Intranasal Insulin and Memory in Early Alzheimer's Disease

Jeff Burns, MD1 site in 1 country31 target enrollmentOctober 2007

Overview

Phase
Phase 1
Intervention
Insulin Aspart
Conditions
Alzheimer's Disease
Sponsor
Jeff Burns, MD
Enrollment
31
Locations
1
Primary Endpoint
fMRI Measure of Hippocampal Activation
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

To determine which parts of the brain are involved in insulin-related memory improvement in early Alzheimer's disease and cognitively normal older adults.

Detailed Description

Functional MRI study to characterize the neuroanatomic correlates of acute exogenous insulin-related improvements in cognitive performance in early Alzheimer's disease and cognitively normal older adults. The role of the apoE-e4 allele in modulating brain insulin responses is also addressed.

Registry
clinicaltrials.gov
Start Date
October 2007
End Date
May 2012
Last Updated
10 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Jeff Burns, MD
Responsible Party
Sponsor Investigator
Principal Investigator

Jeff Burns, MD

Professor, Associate Director University of Kansas Alzheimer's Disease Center

University of Kansas Medical Center

Eligibility Criteria

Inclusion Criteria

  • Patients with Early Alzheimer's disease

Exclusion Criteria

  • Patients with Late Alzheimer's disease

Arms & Interventions

Intranasal Insulin Aspart

Participants were administered intranasal insulin aspart (40 IU) in a double-blinded fashion approximately 30 minutes prior to functional MRI scanning. After a washout period of 48 hours, participants completed the other arm. The order of saline vs. insulin was counterbalanced.

Intervention: Insulin Aspart

Intranasal Saline (placebo)

Participants were administered intranasal saline (placebo) in a double-blinded fashion approximately 30 minutes prior to functional MRI scanning. After a washout period of 48 hours, participants completed the other arm. The order of saline vs. insulin was counterbalanced.

Intervention: Placebo

Outcomes

Primary Outcomes

fMRI Measure of Hippocampal Activation

Time Frame: 30 minutes After Intervention Administration

Percentage active voxels of total hippocampal volume of interest

Secondary Outcomes

  • Global Cognition(90 mins)

Study Sites (1)

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