SNIFF Multi-Device Study 2

• Status: Active, not recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The SNIFF Device study will involve using one of three devices to administer insulin through each participant's nose or intra-nasally, accompanied by a lumbar puncture. This goal of this study is to measure how much insulin the device delivers to the cerebrospinal fluid (CSF). In addition, this study will look at the effects of insulin administered intra-nasally on memory, and on blood levels of insulin.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Treatments: Insulin; Insulin, Globin Zinc; Insulin, Isophane

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 regular use of insulin or any other anti-diabetic medication within 2 months of screening visit.

• 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, anti-parkinsonian medications, or any other exclusionary medications