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Nasal Insulin for Alzheimer's

Phase 2
Waitlist Available
Led By Suzanne Craft, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stable medications for 4 weeks prior to the screening and study visits
Stable medical condition for 3 months prior to screening visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 minutes before lumbar puncture, and immediately following lumbar puncture.
Awards & highlights

Study Summary

This trial will test if administering insulin through the nose can help people with Alzheimer’s by measuring how much insulin is delivered to the brain, as well as any effects on memory or blood levels.

Who is the study for?
This trial is for adults with mild cognitive impairment or normal cognition, stable health, and no major psychiatric disorders. They must not be using certain anticoagulants, insulin, or have a history of significant neurological issues like seizures or stroke. Pregnant individuals and those in nursing facilities can't participate.Check my eligibility
What is being tested?
The study tests how well three different devices deliver insulin to the brain's cerebrospinal fluid when administered through the nose. It also examines the effects on memory and blood insulin levels.See study design
What are the potential side effects?
Potential side effects may include discomfort from the nasal device or lumbar puncture procedure, low blood sugar levels due to insulin administration, and possible local irritation at the site of delivery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My medications have been the same for the last 4 weeks.
Select...
My health condition has been stable for the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 minutes before lumbar puncture, and immediately following lumbar puncture.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 minutes before lumbar puncture, and immediately following lumbar puncture. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CSF insulin levels
Secondary outcome measures
Auditory-Verbal Learning Test (AVLT)
Other outcome measures
CSF Levels of AB42

Trial Design

2Treatment groups
Experimental Treatment
Group I: 40 IU Insulin first, then 20 IU InsulinExperimental Treatment1 Intervention
Participants will be randomly assigned to receive regular insulin (U100, 40 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 20 IU) at visit 3 during second intervention period.
Group II: 20 IU Insulin first, then 40 IU InsulinExperimental Treatment1 Intervention
Participants will be randomly assigned to receive regular insulin (U100, 20 IU) administered with an intranasal nebulizer-like device. Participants in this arm will then receive regular insulin (U100, 40 IU) at visit 3 during second intervention period.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,231 Previous Clinical Trials
1,001,783 Total Patients Enrolled
Suzanne Craft, PhDPrincipal InvestigatorWake Forest University Health Sciences
16 Previous Clinical Trials
2,037 Total Patients Enrolled

Media Library

SNIFF Device (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04199767 — Phase 2
Mild Cognitive Impairment Research Study Groups: 40 IU Insulin first, then 20 IU Insulin, 20 IU Insulin first, then 40 IU Insulin
Mild Cognitive Impairment Clinical Trial 2023: SNIFF Device Highlights & Side Effects. Trial Name: NCT04199767 — Phase 2
SNIFF Device (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04199767 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the standard dosage of Humulin® R U-100 for most patients?

"20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly & Company) is a commonly used medication for treating community acquired pneumonia caused by susceptible strains of streptococcus pneumoniae. It is also effective for managing uncomplicated skin and skin structure infections caused by staphylococcus aureus infections, hospital acquired pneumonia, and type 1 diabetes mellitus."

Answered by AI

Is 20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly & Company) a common dose in other medical trials?

"Currently, there are 96 ongoing clinical trials researching 20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly & Company) with 20 trials in Phase 3. While many of the clinical trials for 20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly & Company) are located in Sao Luis, MA, there are 375 locations running studies for 20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly & Company)."

Answered by AI

Has the FDA issued a 20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly & Company) license?

"While there is some evidence that suggests 20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly & Company) is safe, it only received a 2 because this medication has not yet been proven effective."

Answered by AI

What is the target recruitment for this research project?

"This clinical trial is not currently looking for candidates at this time. The trial was first posted on 7/16/2020 and was most recently edited on 10/28/2022. If you are exploring for other studies, there are currently 634 trials actively looking for patients with cognitive impairment (ci) and 96 trials for 20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly & Company) admitting participants."

Answered by AI

May I sign up for this clinical trial?

"The ideal candidate for this trial is somebody aged 55 to 85 who currently struggles with ci. Furthermore, it is a requirement that potential participants have had no changes to their medical condition or medications for at least 3 and 4 months respectively."

Answered by AI

Are geriatric patients being included in this research?

"This trial is only for patients aged 55 to 85. Out of the 661 clinical trials that are available for patients over 65, this one has the most specific age range."

Answered by AI

Are new participants being accepted into this clinical trial at present?

"The clinical trial mentioned is not currently recruiting patients, as indicated by the data on clinicaltrials.gov. This particular study was posted on 7/16/2020 and last updated on 10/28/2022. There are however, 730 other trials that are actively looking for candidates."

Answered by AI
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~9 spots leftby Oct 2025