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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

Be older than 18 years old

Must not have

History of seizure within past five years

Diabetes (type I or type II) insulin dependent and non-insulin dependent diabetes mellitus

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

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.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a seizure in the last five years.

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I have diabetes, whether I use insulin or not.

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I do not regularly use alcohol, narcotics, or specific medications.

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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 (Coumadin) or dabigatran (Pradaxa).

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I have used insulin or other diabetes medications in the last 2 months.

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

Auditory-Verbal Learning Test (AVLT)

Other study objectives

CSF Levels of AB42

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 7Eligibility criteria met