Alzheimer's Disease
Conditions
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.
Interventions
DRUGInsulin Aspart
40IU insulin aspart applied intranasally
DRUGPlacebo
Placebo
Sponsors
Jeff Burns, MD
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients with Early Alzheimer's disease
Exclusion criteria
* Patients with Late Alzheimer's disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| fMRI Measure of Hippocampal Activation | 30 minutes After Intervention Administration | Percentage active voxels of total hippocampal volume of interest |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Cognition | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Includes groups randomized to receive placebo first and insulin first. | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Continuous | 72.9 years STANDARD_DEVIATION 7.1 |
| Region of Enrollment United States | 31 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 29 | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 | 1 / 29 |
Outcome results
Primary
fMRI Measure of Hippocampal Activation
Percentage active voxels of total hippocampal volume of interest
Time frame: 30 minutes After Intervention Administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Insulin Aspart | fMRI Measure of Hippocampal Activation | 36.4 percentage of active voxels | Standard Deviation 31.4 |
| Placebo | fMRI Measure of Hippocampal Activation | 41.3 percentage of active voxels | Standard Deviation 33.5 |
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.
Time frame: 90 mins
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intranasal Insulin Aspart | Global Cognition | -.05 z-scores | Standard Deviation 1.15 |
| Placebo | Global Cognition | -.02 z-scores | Standard Deviation 1.11 |