Nasal Insulin for Cognitive Impairment
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a device that delivers insulin through the nose (intranasal insulin) to evaluate its effects on memory and brain function. Insulin, a hormone that typically lowers blood sugar, might also benefit cognitive health. Participants will either start with insulin and switch to a placebo or vice versa to compare results. The trial seeks individuals who are fluent in English, have mild memory issues (but not dementia), and haven't recently used insulin. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop taking my current medications for the trial?
The trial requires that your medications be stable for at least 4 weeks before the screening and study visits. Some medications, like insulin, anti-diabetic drugs, anticoagulants, and certain others, are not allowed during the trial.
What prior data suggests that this device is safe for administering insulin intra-nasally?
Research has shown that using insulin through the nose is safe and generally well-tolerated. For instance, a study with Alzheimer's patients found no major safety concerns. Another study involving people with multiple sclerosis also found that intranasal insulin was well-tolerated, with no serious side effects compared to a placebo. Although the treatment did not consistently improve memory or thinking skills, no serious safety issues arose. This suggests that intranasal insulin could be a safe option for those considering participation in a clinical trial.12345
Why are researchers excited about this study treatment for cognitive impairment?
Unlike the standard treatments for cognitive impairment, like cholinesterase inhibitors and memantine, intranasal insulin offers a unique approach. This treatment is administered through the nose using a nebulizer-like device, which could enhance insulin delivery directly to the brain, potentially improving memory and cognitive function. Researchers are excited about this method because it bypasses the blood-brain barrier more effectively than traditional methods, offering a promising new avenue for tackling cognitive decline.
What evidence suggests that this device is effective for cognitive impairment?
Research has shown that using insulin through a nasal spray might improve memory and thinking skills in people with Alzheimer's disease. Some studies found that small doses, like 20 IU, can boost memory and learning. This trial will test two different sequences: one group will receive insulin first, followed by a placebo, while the other group will receive a placebo first, followed by insulin. This method delivers insulin directly to the brain, which might benefit people with brain disorders. However, not all studies agree, and some found no major improvements in people with mild memory problems. Overall, while results are mixed, evidence suggests that nasal insulin could aid memory and learning.14567
Who Is on the Research Team?
Suzanne Craft
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either insulin or placebo administered intranasally using a nebulizer-like device
Follow-up
Participants are monitored for changes in CSF insulin levels, AD biomarkers, and memory performance
What Are the Treatments Tested in This Trial?
Interventions
- Intranasal Insulin
Intranasal Insulin is already approved in United States, European Union for the following indications:
- Diabetes
- Diabetes
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor