SNIFF Multi-Device Study 2
Completed · Phase 2
Conditions studied: Mild Cognitive Impairment, Cognitive Impairment
In brief
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.
Key facts
- Study ID
- NCT04199767
- Run by
- Wake Forest University Health Sciences
- People needed
- 13
- Starts
- 2020-07-16
- Expected to finish
- 2020-11-03
- Last updated by the study team
- 2026-04-02
Who can join
Age: 55 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
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