Insulin for Alzheimer's Disease

(MIND-IT Trial)

Overseen By Candida Rebello, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pennington Biomedical Research Center

Must not be taking: Benzodiazepines

Disqualifiers: Children, Pregnant, Prisoners, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

8 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a weekly insulin treatment can improve memory and brain function in people with Alzheimer's Disease. Researchers aim to determine if this insulin method can enhance the body's sugar use and boost cognitive skills. They also seek to observe changes in the brain's sugar uptake. Individuals with Alzheimer's symptoms who notice memory problems in daily life might be suitable candidates. Participants will receive insulin sessions once a week for six months, with each session lasting up to two hours. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance Alzheimer's treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on daily medication for anxiety, like benzodiazepines.

What prior data suggests that this intervention is safe for adults with Alzheimer's Disease?

Research has shown that insulin is safely used in other medical conditions, such as diabetes. In studies with Alzheimer's patients, insulin showed promise in improving memory and reducing brain changes related to the disease in mice. While these findings are encouraging, they do not specifically address safety for humans in this trial.

Insulin is generally safe when used properly. Common side effects in other uses include low blood sugar, which can cause dizziness or shakiness. This trial uses a different method of administering insulin than the usual diabetes treatment, which might alter the body's reaction.

Since this trial is in its early stages, limited safety information exists for humans using this method. Therefore, researchers will closely monitor participants for any side effects during the study. This ensures the treatment remains safe throughout the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for Alzheimer's disease focus on managing symptoms with medications like donepezil or memantine, but this new insulin treatment works differently. Researchers are excited because it uses physiological insulin intervention, which targets brain function directly. Administered through regular insulin infusions, this approach could enhance brain metabolism and potentially improve cognitive function, offering a novel mechanism of action compared to current therapies. Its unique delivery method and potential to modify the disease process itself set it apart from existing options.

What evidence suggests that this treatment might be an effective treatment for Alzheimer's Disease?

Research suggests that insulin might help with Alzheimer's disease. Some studies have shown that insulin can improve memory and attention when administered in specific ways. For example, people with Alzheimer's demonstrated better memory during insulin treatment compared to when they did not receive it. Animal studies have also shown that insulin can lower levels of harmful proteins in the brain linked to Alzheimer's. However, not all studies agree, and more research is needed to confirm these findings in humans. Participants in this trial will receive a physiologic insulin intervention, involving insulin infusion at five-minute intervals over approximately two hours weekly for six months, to further investigate its potential benefits. ^{2 3 6 7 8}

Who Is on the Research Team?

Tim Gilbert, M.D.

Principal Investigator

Pennington Biomedical Research Center

Are You a Good Fit for This Trial?

This trial is for adults with Alzheimer's Disease who may also have insulin resistance. It aims to see if a special way of giving insulin can help their bodies use glucose better and improve their thinking skills. Participants will get this treatment weekly for 6 months.

Inclusion Criteria

Mini Mental State Examination (MMSE) score < 25

Exclusion Criteria

I take daily medication for anxiety, including benzodiazepines.

I am under 18 years old.

A pregnant woman

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive insulin infusion at five-minute intervals over approximately two hours weekly for six months

6 months

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Physiological Insulin Intervention

Trial Overview The study tests whether short, regular bursts of insulin can boost how well the body uses sugar and make cognitive functions better in people with Alzheimer's. They'll check this by using brain scans (FDG-PET) and mental tests like MoCA and RMBPC.

How Is the Trial Designed?

Group I: Physiologic Insulin Experimental Treatment 1 Intervention

Insulin infusion at five-minute intervals over approximately two hours weekly for six months. Initially infusion will be weekly and then frequency will reduce based on participants' response.

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/PMC3540744/

Insulin: An Emerging Treatment for Alzheimer's Disease ... Individuals with high infusion rates and serum insulin levels exhibited improved memory performance and attention during intravenous insulin infusion [35]. Two ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07265323

Study Details | NCT07265323 | Effect of Physiologic Insulin ... The goal of this clinical trial is to determine if a weekly delivery of insulin at short intervals lasting up to 2 hours can improve insulin sensitivity and ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0197458015005576

Cognitively impaired elderly exhibit insulin resistance and ... In this study, although insulin resistance was observed in cognitively impaired subjects compared to ND controls, insulin infusion did not improve memory.

4. 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., ...

5. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/205557

Enhancement of Memory in Alzheimer Disease With Insulin ... Results Patients with AD showed improved memory during hyperinsulinemia relative to placebo (P = .05) and relative to hyperglycemia (P<.005). Memory did not ...

6. 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.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4465775/

Brain insulin resistance in Alzheimer's disease and its ... This review describes the significance, nature and potential treatment of brain insulin resistance with a relatively new class of antidiabetics.

8. academic.oup.com academic.oup.com/brain/article/146/1/75/6761474

Cerebrovascular insulin receptors are defective in Alzheimer's ... Central response to insulin is suspected to be defective in Alzheimer's disease. As most insulin is secreted in the bloodstream by the ...