- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02462161
Study of Nasal Insulin to Fight Forgetfulness - Short-Acting Insulin Aspart (SNIFF-Quick)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Previous or subsequent diagnosis of Alzheimer's disease or mild cognitive impairment
- Ability to communicate in English
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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Participants will administer 20 IU insulin aspart two times per day with an intranasal delivery device.
Other Names:
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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.
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Participants will administer placebo two times per day with an intranasal delivery device.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cognition
Time Frame: 6 weeks and 12 weeks
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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)
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6 weeks and 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Blood - every 6 weeks for 12 weeks; cerebral spinal fluid (CSF) - baseline and week 12
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MRI measure of cortical thickness in Alzheimer's disease (AD) -vulnerable regions
Time Frame: Baseline and week 12
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Baseline and week 12
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Cognition Disorders
- Alzheimer Disease
- Cognitive Dysfunction
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Insulin
- Insulin, Globin Zinc
- Insulin Aspart
- Insulin, Long-Acting
- Insulin degludec, insulin aspart drug combination
Other Study ID Numbers
- IRB00026106
- 5P50AG005136-30 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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