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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

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 minutes before lumbar puncture, and immediately following lumbar puncture

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

CSF insulin levels

Secondary study objectives

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

0 / 7Eligibility criteria met