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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
Be older than 18 years old
Must not have
Diabetes (type I or type II) insulin dependent and non-insulin dependent diabetes mellitus
History of a clinically significant stroke
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 minutes before lumbar puncture, and immediately following lumbar puncture
Awards & highlights

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have diabetes, whether I use insulin or not.
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I have had a serious stroke in the past.
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I haven't had epilepsy, major head injuries, or severe mental health issues in the last 2 years.
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I am taking warfarin or dabigatran for blood thinning.
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I do not regularly use alcohol, narcotics, or certain medications.
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I have had a seizure in the last five years.
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I have been diagnosed with dementia.

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
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin
2000
Completed Phase 4
~4280

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,253 Previous Clinical Trials
1,010,902 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
~5 spots leftby Aug 2025
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