Status:
COMPLETED
Study of Nasal Insulin to Fight Forgetfulness - Device Study
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Mild Cognitive Impairment
Cognitive Impairment
Eligibility:
All Genders
55-85 years
Phase:
PHASE2
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 level...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03857321
Start Date
April 12 2019
End Date
September 30 2019
Last Update
October 31 2025
Active Locations (1)
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1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157