Study of Nasal Insulin to Fight Forgetfulness - Short-Acting Insulin Aspart (SNIFF-Quick)
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|ClinicalTrials.gov Identifier: NCT02462161|
Recruitment Status : Completed
First Posted : June 3, 2015
Last Update Posted : May 12, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease Mild Cognitive Impairment||Drug: Insulin aspart Drug: Placebo||Phase 1|
A growing body of evidence suggests that insulin plays a role in normal memory processes and that insulin abnormalities may contribute to cognitive and brain changes associated with Alzheimer's disease (AD). Interestingly, insulin administered to the nasal cavity is transported within a few minutes into the brain, but does not affect blood sugar or insulin levels.
This trial will consist of a randomized double-blind, placebo-controlled parallel group trial in which 30 participants with AD or mild cognitive impairment (MCI) receive twice daily intranasal administrations of insulin aspart (20 IU) or placebo (saline), two times per day for 12 weeks. All participants will appoint a "support person" to answer a collateral questionnaire and supervise the administration of the study drug. All participants and study partners will undergo the intensive, structured training program in the self-management of intranasal insulin administration. Cognitive testing and blood collection will occur at baseline, after 6 weeks of treatment, and at the end of the 12 week treatment period. Participants will also receive a lumbar puncture to measure AD biomarkers in the subject's cerebral spinal fluid.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Study of Nasal Insulin to Fight Forgetfulness - Short-Acting Insulin Aspart|
|Actual Study Start Date :||March 20, 2015|
|Actual Primary Completion Date :||April 16, 2019|
|Actual Study Completion Date :||April 16, 2019|
Experimental: Insulin Aspart
Fifteen randomly assigned participants with Alzheimer's disease or mild cognitive impairment will receive twice daily intranasal administrations of insulin aspart (20 IU) for 12 weeks.
Drug: Insulin aspart
Participants will administer 20 IU insulin aspart two times per day with an intranasal delivery device.
Other Name: NovoLog Fast-Acting Insulin Aspart
Placebo Comparator: Placebo
Fifteen randomly assigned participants with Alzheimer's disease or mild cognitive impairment will receive twice daily intranasal administrations of placebo (saline) for 12 weeks.
Participants will administer placebo two times per day with an intranasal delivery device.
Other Name: Saline
- Change in cognition [ Time Frame: 6 weeks and 12 weeks ]Alzheimer's Disease Assessment Scale-Cognitive Subscale(ADAS-Cog)/mild cognitive impairment (MCI) scores and memory composite (summed Z scores from delayed story and list recall)
- Cerebral spinal fluid (CSF) and blood amyloid-beta, tau protein, and inflammatory markers [ Time Frame: Blood - every 6 weeks for 12 weeks; cerebral spinal fluid (CSF) - baseline and week 12 ]
- MRI measure of cortical thickness in Alzheimer's disease (AD) -vulnerable regions [ Time Frame: Baseline and week 12 ]
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|Ages Eligible for Study:||50 Years to 89 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Previous or subsequent diagnosis of Alzheimer's disease or mild cognitive impairment
- Ability to communicate in English
- Preexisting diabetes
- Clinically significant elevations in liver function test
- Clinically significant elevations in lipid profile
- Prior lumbar lumbar surgeries or other medical conditions that render lumbar punctures unsafe
- Hemoglobin <8 g/dl
- Significant neurologic disease that might affect cognition, other than Alzheimer's disease, including stroke, Parkinson's disease, multiple sclerosis, or recent severe head injury (within the last year) with loss of consciousness >30 minutes or with permanent neurologic sequelae
- Significant medical illness or organ failure, such as uncontrolled hypertension or cardiovascular disease, chronic obstructive pulmonary disease, liver disease, or kidney disease
- Current use of antipsychotic, anticonvulsant, anxiolytic, anticoagulant or sedative medications
- Current or previous use of glucose-lowering agents or insulin;
- Chronic use (≥ 3 times per week) of nasal sprays of any type for any indication
- Premenopausal status (defined as having had a period within the last year).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02462161
|United States, North Carolina|
|Wake Forest Baptist Hospital|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Suzanne Craft, PhD||Wake Forest University Health Sciences|
Documents provided by Wake Forest University Health Sciences:
|Responsible Party:||Wake Forest University Health Sciences|
|Other Study ID Numbers:||
5P50AG005136-30 ( U.S. NIH Grant/Contract )
|First Posted:||June 3, 2015 Key Record Dates|
|Last Update Posted:||May 12, 2020|
|Last Verified:||August 2019|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
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