Trials / Withdrawn
WithdrawnNCT05006599
SNIFF - 3-Week Aptar CPS Device
Study of Nasal Insulin to Fight Forgetfulness (SNIFF) - 3-Week Aptar CPS Device
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Wake Forest University Health Sciences · Academic / Other
- Sex
- All
- Age
- 55 Years – 85 Years
- Healthy volunteers
- Accepted
Summary
The SNIFF 3-Week Aptar Device study will involve using a device to administer insulin or placebo 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 an intranasal delivery device on memory, blood, and cerebrospinal fluid (CSF).
Detailed description
The proposed study will examine whether an intranasal delivery device can be used by adults with preclinical Alzheimer's disease (cognitively normal but with abnormal brain levels of the hallmark peptide Aβ) to reliably deliver insulin or placebo four times daily over a 4 week period. We will also examine effects of treatment on cognition, CSF biomarkers, and cerebral perfusion. If successful, information gained from the study will inform the design of future Phase III trials of intranasal insulin.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Insulin (Humulin® R U-100) | Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device. |
| DRUG | Placebo | Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device. |
| DEVICE | Aptar Pharma CPS Intranasal Delivery Device | Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device. |
Timeline
- Start date
- 2025-05-01
- Primary completion
- 2029-05-01
- Completion
- 2031-05-01
- First posted
- 2021-08-16
- Last updated
- 2025-07-28
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05006599. Inclusion in this directory is not an endorsement.