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To determine which parts of the brain are involved in insulin-related memory improvement in early Alzheimer's disease and cognitively normal older adults.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal Insulin Aspart | Experimental | 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. |
|
| Intranasal Saline (placebo) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Aspart | Drug | 40IU insulin aspart applied intranasally |
|
| Measure | Description | Time Frame |
|---|---|---|
| fMRI Measure of Hippocampal Activation | Percentage active voxels of total hippocampal volume of interest | 30 minutes After Intervention Administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey M Burns, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center, Hoglund Brain Imaging Center | Kansas City | Kansas | 66160 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo First, Then Intranasal Insulin | Participants in this group were randomized to receive placebo at the first fMRI visit and then received Intranasal Insulin at the second fMRI visit. |
| FG001 | Intranasal Insulin First, Then Placebo | Participants in this group were randomized to receive Intranasal Insulin at the first fMRI visit and then received Placebo at the second fMRI visit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Second Intervention |
|
31 total participants were enrolled in the study. 29 completed the study and had, in a counterbalanced order, one-dose of intranasal insulin followed by fMRI and over 48 hours later a dose of intranasal saline followed by fMRI.
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes groups randomized to receive placebo first and insulin first. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | fMRI Measure of Hippocampal Activation | Percentage active voxels of total hippocampal volume of interest | Posted | Mean | Standard Deviation | percentage of active voxels | 30 minutes After Intervention Administration |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intranasal Insulin Aspart | Intranasal Insulin was administered in either first or second intervention period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Respiratory, thoracic and mediastinal disorders | An individual died 38 days after having one dose of intranasal saline (placebo) during the washout period due to pulmonary embolism and prior to returning for intranasal insulin. The death was considered unrelated to the intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey Burns | University of Kansas Medical Center | (913) 588-0555 | jburns2@kumc.edu |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Placebo | Drug | Placebo |
|
|
| 90 mins |
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | z-scores | 90 mins |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Placebo | Placebo was administered in either first or second intervention period. | 1 | 29 | 0 | 29 |
|
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |