- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00581867
Memory and Insulin in Early Alzheimer's Disease (MAIN)
July 10, 2015 updated by: Jeff Burns, MD
Intranasal Insulin and Memory in Early Alzheimer's Disease
To determine which parts of the brain are involved in insulin-related memory improvement in early Alzheimer's disease and cognitively normal older adults.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center, Hoglund Brain Imaging Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with Early Alzheimer's disease
Exclusion Criteria:
- Patients with Late Alzheimer's disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
40IU insulin aspart applied intranasally
Other Names:
|
Active Comparator: 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.
|
Placebo
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
fMRI Measure of Hippocampal Activation
Time Frame: 30 minutes After Intervention Administration
|
Percentage active voxels of total hippocampal volume of interest
|
30 minutes After Intervention Administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Global Cognition
Time Frame: 90 mins
|
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.
|
90 mins
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jeffrey M Burns, MD, University of Kansas Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
December 19, 2007
First Submitted That Met QC Criteria
December 19, 2007
First Posted (Estimate)
December 28, 2007
Study Record Updates
Last Update Posted (Estimate)
July 14, 2015
Last Update Submitted That Met QC Criteria
July 10, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10896
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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