Back to resultsMemory and Insulin in Early Alzheimer's Disease (MAIN)
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Insulin Aspart
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Alzheimer's Disease
Eligibility Criteria
Inclusion Criteria:
- Patients with Early Alzheimer's disease
Exclusion Criteria:
- Patients with Late Alzheimer's disease
Sites / Locations
- University of Kansas Medical Center, Hoglund Brain Imaging Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intranasal Insulin Aspart
Intranasal Saline (placebo)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
fMRI Measure of Hippocampal Activation
Percentage active voxels of total hippocampal volume of interest
Secondary Outcome Measures
Global Cognition
Results derived from standardized z-score averaging performance across a battery of cognitive tests. The tests used include the Wechsler Memory Scale [WMS]-Revised Logical Memory I and II which measures a person's memory. Also used was the Wechsler Adult Intelligence Scale [WAIS] which measures intelligence in adults. The Trail Making A and B test was used to measure visual attention and task switching. The WAIS Block Design was done to test visuospatial and motor skills. The final test included in this measure is the Mini-Mental State Examination [MMSE]. The MMSE involves 30 questions and screens for cognitive impairment. Scores for each test were standardized to characterized individual global cognitive performance. The z-score reflects the standardized score. A positive z-score reflects a result above the average. A negative z-score reflects a result below the average.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00581867
Brief Title
Memory and Insulin in Early Alzheimer's Disease
Acronym
MAIN
Official Title
Intranasal Insulin and Memory in Early Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jeff Burns, MD
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intranasal Insulin Aspart
Arm Type
Experimental
Arm Description
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.
Arm Title
Intranasal Saline (placebo)
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Insulin Aspart
Other Intervention Name(s)
intranasal insulin
Intervention Description
40IU insulin aspart applied intranasally
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
saline
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
fMRI Measure of Hippocampal Activation
Description
Percentage active voxels of total hippocampal volume of interest
Time Frame
30 minutes After Intervention Administration
Secondary Outcome Measure Information:
Title
Global Cognition
Description
Results derived from standardized z-score averaging performance across a battery of cognitive tests. The tests used include the Wechsler Memory Scale [WMS]-Revised Logical Memory I and II which measures a person's memory. Also used was the Wechsler Adult Intelligence Scale [WAIS] which measures intelligence in adults. The Trail Making A and B test was used to measure visual attention and task switching. The WAIS Block Design was done to test visuospatial and motor skills. The final test included in this measure is the Mini-Mental State Examination [MMSE]. The MMSE involves 30 questions and screens for cognitive impairment. Scores for each test were standardized to characterized individual global cognitive performance. The z-score reflects the standardized score. A positive z-score reflects a result above the average. A negative z-score reflects a result below the average.
Time Frame
90 mins
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with Early Alzheimer's disease
Exclusion Criteria:
Patients with Late Alzheimer's disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey M Burns, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center, Hoglund Brain Imaging Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
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Memory and Insulin in Early Alzheimer's Disease
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