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Hormone Therapy

Nasal Insulin for Cognitive Impairment

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
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 a new way of delivering insulin - through the nose - to see if it is effective and has an impact on memory, blood sugar, and cerebral spinal fluid.

Who is the study for?
This trial is for individuals with mild cognitive impairment or normal cognition, stable health, and medication use. Participants must have normal lab values or non-significant abnormalities, speak English fluently, and not be pregnant. Excluded are those with regular alcohol/drug use, significant stroke history, any diabetes type, recent insulin/anti-diabetic drugs usage, seizures in the last five years, nursing home residents, investigational drug users within two months prior to screening visit.Check my eligibility
What is being tested?
The study tests a nasal device delivering insulin to see if it affects memory and other cognitive functions. It compares the effects of insulin versus placebo administered through an intranasal nebulizer-like device on participants' memory performance as well as blood and cerebral spinal fluid markers.See study design
What are the potential side effects?
While specific side effects are not listed for this trial's interventions (insulin via nasal delivery), common concerns may include irritation at the administration site or systemic effects like low blood sugar levels.

Eligibility Criteria

Inclusion Criteria

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


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
CSF Levels of AB42
CSF Levels of total tau
CSF Levels phospho-tau 181
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo first, then insulinExperimental Treatment3 Interventions
Participants will be randomly assigned to receive placebo administered with an intranasal nebulizer-like device. At visit 3 during second intervention period, participants in this arm will receive insulin.
Group II: Insulin first, then placeboExperimental Treatment3 Interventions
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 placebo at visit 3 during second intervention period.
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 4

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,235 Previous Clinical Trials
1,002,872 Total Patients Enrolled
Suzanne Craft, PhDPrincipal InvestigatorWake Forest University Health Sciences
16 Previous Clinical Trials
2,037 Total Patients Enrolled

Media Library

Intranasal Insulin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03857321 — Phase 2
Mild Cognitive Impairment Research Study Groups: Insulin first, then placebo, Placebo first, then insulin
Mild Cognitive Impairment Clinical Trial 2023: Intranasal Insulin Highlights & Side Effects. Trial Name: NCT03857321 — Phase 2
Intranasal Insulin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03857321 — Phase 2

Frequently Asked Questions

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

How many participants are anticipated for this research endeavor?

"This medical study is no longer enrolling participants. The trial was initially advertised on April 12th 2019 and the most recent update appeared February 9th 2022. If you are still searching for trials that may suit your needs, there are 610 studies accepting patients with cognitive impairment (CI) and 87 intranasal nebulizer-like device related projects welcoming volunteers."

Answered by AI

To what extent is utilization of an intranasal nebulizer-like device hazardous for individuals?

"Our team at Power gave intranasal nebulizer-like device a score of 2, as there is some clinical research suggesting its safety but not yet any that investigates its efficacy."

Answered by AI

Is it still possible to join this trial as a participant?

"Currently, this trial is not accepting patients and has been inactive since February 9th 2022. If you are still seeking a clinical trial to participate in, there are 610 studies recruiting participants with cognitive impairment (ci) as well as 87 trials looking for individuals using an intranasal nebulizer-like device."

Answered by AI

What ailments can be alleviated through the use of an intranasal nebulizer?

"Through the use of a nebulizer-like device, community acquired pneumonia due to streptococcus pneumoniae, uncomplicated skin and soft tissue infections caused by staphylococcus aureus as well as hospital acquired pneumonias can be effectively treated."

Answered by AI

Could you provide details on any prior experiments involving inhalable nebulizing tools?

"Currently, 87 studies are underway assessing the efficacy of intranasal nebulizer-like device. Nineteen of these investigations have reached Phase 3 and are being conducted in 359 distinct sites with a concentration around Sao Luis, MA."

Answered by AI

Does the protocol for this experiment permit those aged seventy-five and over to participate?

"This trial stipulates that the age range of participants must be between 55 and 85 years old."

Answered by AI

Is it feasible for me to participate in this clinical experiment?

"This clinical trial is seeking 21 participants with cognitive impairment (CI) aged 55 to 85."

Answered by AI
~6 spots leftby Aug 2025