Insulin Treatment for Alzheimer's Disease

Age: 65+

Sex: Male

Trial Phase: Academic

Sponsor: Pennington Biomedical Research Center

Disqualifiers: Inability to walk, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether insulin, typically used to control blood sugar, can enhance brain function in individuals with early Alzheimer's disease. Researchers aim to determine if administering insulin in pulses, rather than a steady stream, can boost brain energy and improve cognitive skills. The trial seeks participants with early Alzheimer's and insulin resistance, a condition where the body doesn't respond well to insulin. Participants will undergo tests of their cognitive and walking skills before and after the insulin treatment to assess any improvement. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new Alzheimer's treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this insulin treatment is safe for Alzheimer's patients?

Research has shown that insulin can be safe for people with Alzheimer's. An early study demonstrated that insulin administered nasally improved memory without causing safety issues. Another study examined insulin's potential to protect the brain and help remove harmful proteins associated with Alzheimer's.

This treatment builds on findings that insulin can support brain function. Although the current trial using pulsed insulin is new, earlier studies suggest that insulin treatments are generally well-tolerated. This study will focus on just one patient, so further research will be necessary to confirm these results. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard Alzheimer's treatments, which often focus on managing symptoms through medications like cholinesterase inhibitors and memantine, physiologic insulin administration offers a novel approach by targeting the underlying metabolic dysfunctions associated with cognitive impairment. Researchers are excited about this treatment because insulin plays a crucial role in brain function and energy management, and its administration could directly enhance cognitive processes. Additionally, this approach could potentially modify disease progression rather than just alleviating symptoms, offering hope for more effective management of Alzheimer's disease.

What evidence suggests that physiologic insulin administration might be an effective treatment for Alzheimer's Disease?

Research has shown that insulin can improve thinking and memory in people with Alzheimer's Disease (AD). Some studies found that insulin slows the decline of memory and thinking skills in those with AD. Insulin might also aid memory problems and reduce certain harmful proteins in the brain. In conditions like Parkinson's Disease, short bursts of insulin have led to noticeable improvements. Although more research is needed, early results suggest that this insulin treatment could benefit brain health in AD. Participants in this trial will receive physiologic insulin administration to further explore its potential benefits for cognitive impairment in Alzheimer's Disease. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals with early-stage Alzheimer's Disease who also have insulin resistance. Participants must be able to walk, read, understand, and complete questionnaires. Vulnerable populations such as prisoners are not eligible.

Inclusion Criteria

I have been diagnosed with early-stage Alzheimer's disease.

Insulin Resistance

Exclusion Criteria

Unable to read, understand, or complete questionnaire

Belonging to a vulnerable group like prisoners

I cannot walk.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo insulin clamp tests with pulsed insulin administration twice weekly for two weeks

2 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Physiologic Insulin Administration

Trial Overview The study tests if administering insulin in pulses can improve cognition in Alzheimer's patients. It involves a standard test for insulin resistance followed by four sessions where insulin is given in pulses every five minutes over two weeks.

How Is the Trial Designed?

Group I: Single Participant with Evidence of cognitive impairment. Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

Pennington Biomedical Research Center

Lead Sponsor

Trials

314

Recruited

183,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11975293/

Intranasal insulin in Alzheimer disease (diabetes in situ?) In AD, insulin administration improves cognitive function and decelerates cognitive decline. These observations provide compelling support for the concept ...

2. medrxiv.org medrxiv.org/content/10.1101/2024.06.21.24309323v1.full-text

Alzheimer's disease as a form of in situ diabetes The results of our systematic review and meta-analysis provide evidence that administration of INI leads to a significant improvement in ...

3. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2018.00215/full

Insulin Resistance as a Therapeutic Target in the ... Insulin administration has been shown to ameliorate memory deficits and reverse diet-induced increases of Aβ levels in the brain of 3xTg-AD mice (Vandal et al., ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1568163723001587

Insulin-degrading enzyme: Roles and pathways in ... IDE appears crucial for treating impairments associated with Aβ accumulation in the brain in Alzheimer's disease (AD) and diabetic cognitive impairment.

5. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/trc2.70123

First‐in‐human positron emission tomography study of ... Intranasal insulin (INI) is being explored to treat Alzheimer's disease and other conditions. The method of intranasal delivery has been shown ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06424652

Effect of Physiologic Insulin Administration on Cognition The hypothesis is that the signs and symptoms of Alzheimer's disease will improve following four pulsatile clamp treatments.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5409050/

Effects of Regular and Long-Acting Insulin on Cognition and ... In an initial three-week pilot study, intranasal insulin detemir improved memory, with no noted safety issues [9]. In the current study, we ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7873098/

Intranasal Insulin for Alzheimer's Disease - PMC This short narrative review explores the potential of central nervous system (CNS) insulin administration via the intranasal pathway to improve memory ...

9. bmcnephrol.biomedcentral.com bmcnephrol.biomedcentral.com/articles/10.1186/s12882-025-04145-9

The protective effects of insulin on the developing of dementia ... Insulin directly affects Alzheimer's disease pathology by protecting against Aβ synaptotoxicity and modulating clearance through its effect.

10. sciencedirect.com sciencedirect.com/science/article/pii/S1568163724002010

True or false? Alzheimer's disease is type 3 diabetes The link between AD and type 2 diabetes (T2D) has been increasingly revealed by research; the danger of developing both AD and T2D rises exponentially with age.