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SNIFF - 3-Week Aptar CPS Device

NCT05006599 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-07-28

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Suzanne Craft, PhD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2029-05-31
Completion
2031-05-31
FDA Drug
Yes
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05006599 on ClinicalTrials.gov