Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 21 Days
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| City: |
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Seattle |
| State: |
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Washington |
| Zip Code: |
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98108 |
| Conditions: |
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Alzheimer's Disease - Mild Cognitive Impairment |
| Purpose: |
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The study will examine the effects of intranasally administered long-acting insulin detemir
on cognition in persons with Alzheimer's disease (AD) or amnestic mild cognitive impairment
(aMCI). The rationale for these studies is derived from growing evidence that insulin
contributes to multiple brain functions, and that insulin dysregulation can contribute to AD
pathogenesis. Thus, therapies aimed at restoring normal insulin signaling in the CNS may
have beneficial effects on brain function. Intranasal administration of insulin increases
insulin signaling in brain without raising peripheral levels and causing hypoglycemia.
Insulin detemir is an insulin analogue that may have better action in brain than other
insulin formulations because of its albumin binding properties. The investigators will test
the therapeutic effects of intranasally-administered insulin detemir in a dose-finding study
in which participants will receive one of two doses of insulin detemir or placebo for a
three week period. The investigators will test the hypothesis that either dose will improve
memory and daily functioning in persons with AD/aMCI compared with placebo.
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| Study Summary: |
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It is well-known that insulin, a hormone that is naturally secreted by the pancreas, plays
an important physiological role by regulating blood sugar levels in the body. The
investigators now know that insulin plays many important roles in the brain as well.
Insulin seems to be especially active in the part of the brain that corresponds to learning
and memory. Studies have shown that when people have insufficient insulin in the brain
(which, for example, is the case with Type-II diabetes), they are increasingly at risk to
develop memory problems and Alzheimer's disease. In a past study, the investigators
administered intravenous insulin to participants and found that it improves their memory.
However, that particular method would not be a practical intervention for people with
Alzheimer's disease due to the risk of hypoglycemia or exacerbation of insulin resistance.
Instead, the investigators use an "intranasal" method of administration, in which the
insulin is inserted into a device, and administered intranasally. In this method, the
insulin travels directly to the brain, and bypasses the body. Our past studies have also
demonstrated that this can be a reliable way to improve memory, and it does not change the
body's blood glucose levels.
In our past studies, the investigators have used regular insulin, which lasts about 3-4
hours and creates a similar "spike" in insulin that one would have after eating a meal.
However, in normal physiology, the pancreas also releases small and more constant "pulses"
of insulin throughout the day and night, establishing a base level of insulin. Accordingly,
several longer-lasting types of insulin are now available that last closer to 10-12 hours,
mimicking that base level of insulin. The current study uses a long-lasting type of insulin
called "insulin detemir," to determine if learning and memory will benefit from a more
constant supplement of insulin. the investigators want to determine whether this treatment
can benefit people who already have a memory impairment—either they already have a diagnosis
of Alzheimer's disease or are diagnosed with mild cognitive impairment, a condition that
precedes Alzheimer's disease, and whether a lower or higher dose of insulin detemir is more
effective. The investigators will examine cognition, daily function, and different markers
of Alzheimer's disease that are in the blood as outcome measures.
The investigators have these specific aims:
1. The investigators will test the hypothesis that compared to placebo, three weeks of
treatment with intranasal insulin detemir will improve cognition and function in adults
with Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI).
2. The investigators will determine which of two doses of intranasal insulin detemir
produces the greatest improvement in cognition and daily function relative to placebo
for adults with AD or MCI.
To examine these hypotheses, the investigators are recruiting approximately 60 participants
who have been diagnosed with AD or MCI. They will be randomly selected to take a lower dose
of insulin detemir, a higher dose of insulin detemir, or saline (which is an inactive
substance and will serve as a placebo). Cognition and the level of daily function will be
tested before they begin the study drug, and after 3 weeks of the study drug. The
investigators will also measure glucose tolerance and take blood samples to measure markers
of AD in the blood.
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| Criteria: |
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Inclusion Criteria:
- Age 50-89
- Diagnosed with mild cognitive impairment, or mild/moderate AD
Exclusion Criteria:
- Excessively high or low blood pressure, heart rate
- BMI greater than 34
- Pre-existing diabetes not controlled by exercise
- Previous/current use of insulin
- Significant elevations in lipids, liver enzymes
- Menstrual period within the last 12 months
- Significant neurological or medical disorder (other than AD)
- Significant use of nasal decongestants
- Current use of anti-psychotic, anti-convulsive, anxiolytic, glucocorticoids, or
sedative medications
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| NCT ID: |
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NCT01547169 |
| Primary Contact: |
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Principal Investigator
Suzanne Craft, PhD
VA Puget Sound Health Care System; University of Washington School of Medicine
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| Backup Contact: |
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N/A |
| Location Contact: |
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Seattle, Washington 98108
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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