A Phase 1/2 interventional study of Insulin Aspart and Placebo in Alzheimer's Disease, sponsored by Jeff Burns, MD. Completed at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-14.
Sponsored by Jeff Burns, MD · Phase 1/2, Interventional, and Basic science
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 31 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Jeff Burns, MD is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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.
Drug: Placebo
40IU insulin aspart applied intranasally
Also known as: intranasal insulin
Placebo
Also known as: saline
fMRI Measure of Hippocampal Activation
Percentage active voxels of total hippocampal volume of interest
Time frame: 30 minutes After Intervention Administration
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.
Time frame: 90 mins
| Milestone | Placebo First, Then Intranasal Insulin | Intranasal Insulin First, Then Placebo |
|---|---|---|
| Started | 16 | 15 |
| Completed | 16 | 15 |
| Not completed | 0 | 0 |
| Milestone | Placebo First, Then Intranasal Insulin | Intranasal Insulin First, Then Placebo |
|---|---|---|
| Started | 15 | 14 |
| Completed | 15 | 14 |
| Not completed | 0 | 0 |
Percentage active voxels of total hippocampal volume of interest
| percentage of active voxels | Intranasal Insulin Aspart | Placebo |
|---|---|---|
| fMRI Measure of Hippocampal Activation | 36.4 ± 31.4 | 41.3 ± 33.5 |
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.
| z-scores | Intranasal Insulin Aspart | Placebo |
|---|---|---|
| Global Cognition | -.05 ± 1.15 | -.02 ± 1.11 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intranasal Insulin Aspart | — | 0/29 (0%) | 0/29 (0%) |
| Placebo | — | 1/29 (3.4%) | 0/29 (0%) |
| Event | Intranasal Insulin Aspart | Placebo |
|---|---|---|
| DeathRespiratory, thoracic and mediastinal disorders | 0/29 | 1/29 |
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.
| Age, Continuous(years) | Entire Study Population |
|---|---|
| Mean | 72.9 ± 7.1 |
| Sex: Female, Male(Participants) | Entire Study Population |
|---|---|
| Female | 13 |
| Male | 18 |
| Region of Enrollment(participants) | Entire Study Population |
|---|---|
| United States | 31 |
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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