Memory and Insulin in Early Alzheimer's Disease (MAIN)
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
|Official Title:||Intranasal Insulin and Memory in Early Alzheimer's Disease|
- fMRI Measure of Hippocampal Activation [ Time Frame: 30 minutes After Intervention Administration ] [ Designated as safety issue: No ]Percentage active voxels of total hippocampal volume of interest
- Global Cognition [ Time Frame: 90 mins ] [ Designated as safety issue: No ]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.
|Study Start Date:||October 2007|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
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.
Drug: Insulin Aspart
40IU insulin aspart applied intranasally
Other Name: intranasal insulin
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.
Other Name: saline
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581867
|United States, Kansas|
|University of Kansas Medical Center, Hoglund Brain Imaging Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Jeffrey M Burns, MD||University of Kansas|