SNIFF-Quick: Study of Nasal Insulin to Fight Forgetfulness - Short-Acting Insulin Aspart

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT02462161

Collaborator

National Institute on Aging (NIA) (NIH), General Electric (Industry)

Enrollment

Location

Arms

48.9

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This pilot clinical trial will examine the effects of intranasal insulin aspart on cognition, daily function, blood and cerebral spinal fluid markers of Alzheimer's disease, and amyloid deposition in the brain. Participants will be randomly assigned to receive insulin aspart or placebo during a 12-week treatment period.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease Mild Cognitive Impairment	Drug: Insulin aspart Drug: Placebo	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Study of Nasal Insulin to Fight Forgetfulness - Short-Acting Insulin Aspart

Actual Study Start Date :

Mar 20, 2015

Actual Primary Completion Date :

Apr 16, 2019

Actual Study Completion Date :

Apr 16, 2019

Arms and Interventions

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.	Drug: Insulin aspart Participants will administer 20 IU insulin aspart two times per day with an intranasal delivery device. Other Names: 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.	Drug: Placebo Participants will administer placebo two times per day with an intranasal delivery device. Other Names: Saline

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.

Drug: Insulin aspart

Participants will administer 20 IU insulin aspart two times per day with an intranasal delivery device.

Other Names:

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.

Drug: Placebo

Participants will administer placebo two times per day with an intranasal delivery device.

Other Names:

Saline

Outcome Measures

Primary Outcome Measures

Change in cognition [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)

Secondary Outcome Measures

Cerebral spinal fluid (CSF) and blood amyloid-beta, tau protein, and inflammatory markers [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 [Baseline and week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 89 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).