Phase 2
Completed N=20
Study of Nasal Insulin to Fight Forgetfulness - Device Study
Source: ClinicalTrials.gov NCT03857321 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: CSF Insulin Levels — 0.14; 0.15 microUnits/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CSF Insulin Levels |
0.14; 0.15 | — |
| SECONDARY The Auditory-Verbal Learning Test (AVLT) |
7.1; 4.9; 9.4; 8.9 | — |
| SECONDARY CSF Levels of AB42 |
524.5; 536 | — |
| SECONDARY CSF Levels of Total Tau |
431.4; 267.3 | — |
| SECONDARY CSF Levels Phospho-tau 181 |
61.5; 40.6 | — |
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
Data sourced from ClinicalTrials.gov (NCT03857321). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.