Study of Nasal Insulin to Fight Forgetfulness - Device Study

Wake Forest University (WFU)

Status and phase: Completed; Phase 2

Conditions: Cognitive Impairment; Mild Cognitive Impairment

Treatments: Other: Placebo; Device: intranasal nebulizer-like device; Drug: Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT03857321

IRB00055429

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

Insulin first, then placebo

Experimental group

Description:

Participants will be randomly assigned to receive regular insulin (U100, 20 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive placebo at visit 3 during second intervention period.

Treatment:

Drug: Insulin

Device: intranasal nebulizer-like device

Other: Placebo

Placebo first, then insulin

Experimental group

Description:

Participants will be randomly assigned to receive placebo administered with an intranasal nebulizer-like device. At visit 3 during second intervention period, participants in this arm will receive insulin.

Treatment:

Drug: Insulin

Device: intranasal nebulizer-like device

Other: Placebo