Clinical trial NCT03857321: Study of Nasal Insulin to Fight Forgetfulness - Device Study
Official title: Device Study for Intranasal Delivery of Insulin
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Mild Cognitive Impairment
Cognitive Impairment
Keywords: Intranasal Delivery of Insulin
Cognitive Testing
Nasal Insulin
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: At study entry, participants will be randomized to receive either an acute dose of insulin or of placebo first and the other substance on a second visit.
Primary purpose: TREATMENT

Brief summary: The SNIFF Device study will involve using a device to administer insulin through each participant's nose or intra-nasally. Insulin is a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. This study is measuring how much insulin the device delivers. In addition, this study will look at the effects of insulin or placebo administered intra-nasally using a nebulizer-like device on memory, blood, and cerebral spinal fluid.

Detailed description: The aim of this study is to determine the ability of an intranasal delivery device to increase levels of insulin in cerebrospinal fluid (CSF).

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.

The study will consist of a single site, randomized, double-blind trial comparing the acute effects of INI (20 International Units) or placebo delivered with nebulizer-like device on CSF insulin levels, AD biomarkers and memory. At study entry, participants will be randomized to receive either an acute dose of insulin or placebo first, and the other substance on a second visit. Participants who are cognitively normal or who have aMCI (n=30) will be enrolled. The primary outcome measure will be to test the hypothesis that CSF insulin levels will increase 30 minutes after receiving a 20 International Units dose of insulin delivered with a nebulizer-like device, compared to levels achieved 30 minutes after placebo.

Eligibility criteria: Inclusion Criteria:

* Fluent in English
* Cognitively normal or diagnosis of aMCI
* Stable medical condition for 3 months prior to screening visit
* Stable medications for 4 weeks prior to the screening and study visits
* Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be clinically insignificant by the study physician

Exclusion Criteria:

* A diagnosis of dementia
* History of a clinically significant stroke
* Current evidence or history in past two years of epilepsy, head injury with loss of consciousness, any major psychiatric disorder including psychosis, major depression, bipolar disorder
* Diabetes (type I or type II) insulin dependent and non-insulin dependent diabetes mellitus
* Current or past use of insulin or any other anti-diabetic medication within 5 years of Screening visit.
* History of cancer five years prior to screening (history of skin melanoma or stable prostate cancer are not exclusionary)
* History of seizure within past five years
* Pregnancy or possible pregnancy.
* Use of anticoagulants warfarin (Coumadin) and dabigatran (Pradaxa)
* Residence in a skilled nursing facility at screening
* Use of an investigational agent within two months of screening visit
* Regular use of alcohol, narcotics, anticonvulsants, antiparkinsonian medications, or any other exclusionary medications

Primary outcomes:
measure: CSF insulin levels
timeFrame: 30 minutes after intervention administration
Secondary outcomes:
measure: The Auditory-Verbal Learning Test (AVLT)
timeFrame: 5 minutes before lumbar puncture, and immediately following lumbar puncture
measure: CSF Levels of AB42
timeFrame: 30 minutes after intervention administration
measure: CSF Levels of total tau
timeFrame: 30 minutes after intervention administration
measure: CSF Levels phospho-tau 181
timeFrame: 30 minutes after intervention administration
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Suzanne Craft, PhD
role: PRINCIPAL_INVESTIGATOR
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