What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease, such as levodopa, dopamine agonists, and MAO-B inhibitors, often come with side effects. Levodopa can cause nausea, dizziness, and dyskinesia (involuntary movements). Dopamine agonists may lead to side effects like hallucinations, sleepiness, and impulse control disorders. MAO-B inhibitors can cause headaches, joint pain, and insomnia. Intranasal insulin, which is being studied for its potential to improve neuronal signaling and reduce inflammation, has shown promise but may also carry risks such as nasal irritation and hypoglycemia. Patients should discuss these potential side effects with their healthcare provider to tailor the best treatment plan.

What prior FDA approvals exist?

FDA-approved treatments for Parkinson's Disease primarily focus on managing motor symptoms through dopaminergic therapies. These include levodopa, often combined with carbidopa, and dopamine agonists like pramipexole and ropinirole. Additionally, MAO-B inhibitors such as selegiline and rasagiline help increase dopamine levels. While these treatments primarily target dopamine pathways, newer approaches like intranasal insulin aim to improve neuronal signaling and reduce inflammation, though specific FDA approvals for such treatments are still under investigation.

What other types of research exist?

Promising novel alternatives to intranasal insulin for Parkinson's Disease patients in 2024 may include: 1) Antisense oligonucleotide therapies, which target specific genetic mutations to reduce harmful protein production. 2) Gene therapy approaches, such as using adeno-associated viruses to deliver therapeutic genes. 3) Neuroprotective agents that aim to protect neurons from degeneration. 4) Anti-inflammatory drugs that specifically target neuroinflammation. Patients should discuss these options with their healthcare provider to determine the best course of action.

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Insulin

Intranasal Insulin for Parkinson's Disease (INI-PD Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for Parkinson's Disease (PD) primarily aim to restore dopaminergic function, reduce neuroinflammation, and protect neurons. Levodopa, often combined with carbidopa, is the most effective treatment, converting to dopamine in the brain to alleviate motor symptoms. Dopamine agonists mimic dopamine effects, while MAO-B inhibitors prevent dopamine breakdown. Intranasal insulin, an emerging treatment, enhances neuronal signaling and reduces inflammation, potentially offering neuroprotective benefits. These mechanisms are crucial for PD patients as they address both symptom management and underlying disease progression, improving quality of life and potentially slowing neurodegeneration.

Phase 2

Waitlist Available

Led By Julia C Johnson, MD

Research Sponsored by HealthPartners Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is > 40 and <90 years of age

Subject has a MOCA score ≥10

Must not have

Subject has history of any of the following: moderate to severe pulmonary disease, poorly controlled congestive heart failure, significant cardiovascular and/or cerebrovascular events within previous 6 months, condition known to affect absorption, distribution, metabolism, or excretion of drugs such as any hepatic, renal or gastrointestinal disease or any other clinically relevant abnormality that inclusion would pose a safety risk to the subject as determined by investigator

Subject has had previous nasal and/or oto-pharyngeal surgery and severe deviated septum and/or other anomalies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 weeks

Summary

This trial will test if giving insulin through the nose can help improve memory, mood, and movement in people with Parkinson's disease over a short period.

Who is the study for?

This trial is for people aged 40-90 with Parkinson's Disease (PD) who show specific symptoms like bradykinesia, without other causes of Parkinsonism. They must be on stable PD medication, have a MOCA score ≥10, and if female, not be pregnant or are post-menopausal. Exclusions include insulin-dependent diabetes, recent nasal surgery, certain neurological conditions other than idiopathic PD, severe heart or lung disease, psychiatric illnesses posing safety risks, drug/alcohol abuse history.

What is being tested?

The study tests the effects of intranasal insulin versus placebo on cognition, mood and motor skills in PD patients over three weeks. Participants will receive either Regular Novolin R (insulin) or a placebo through the nose to see if it improves their condition.

What are the potential side effects?

Potential side effects may include local irritation inside the nose from regular use of the nasal spray and systemic effects related to insulin such as low blood sugar levels especially important for those who do not normally require insulin therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 40 and 90 years old.

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My mental function score is 10 or higher.

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I have been diagnosed with Parkinson's disease by a specialist.

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I am post-menopausal or have a negative pregnancy test.

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My Parkinson's disease is in the early or mid-stage.

Exclusion Criteria

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

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I have severe lung, heart, liver, kidney, or digestive diseases or had a major heart or brain event recently.

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I have had surgery on my nose or throat and have a severe deviated septum or other issues.

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I have a Parkinson's-like condition not caused by typical Parkinson's disease.

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I use insulin to manage my diabetes.

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I am not taking any sedatives that my doctor says are unsafe for me.

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I have chronic sinusitis, untreated thyroid disease, or had significant head trauma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Safety measured by body weight

Safety measured by count of safety events

Safety measured by fasting glucose

+1 more

Secondary study objectives

Apathy measured by the Apathy scale

Cognitive function measured by Fluency

Cognitive function measured by the Hopkins Verbal Learning Test - Revised (HVLT)

+13 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Medium InsulinExperimental Treatment1 Intervention

Regular insulin (Novolin-R) 40 international units (10 units) in each nostril twice daily for 21 days, 100 µl volume.

Group II: Low InsulinExperimental Treatment1 Intervention

Regular insulin (Novolin-R) 20 international units (10 units) in one nostril twice daily for 21 days, 100 µl volume.

Group III: High InsulinExperimental Treatment1 Intervention

Regular insulin (Novolin-R) 80 international units (10 units) in each nostril twice daily for 21 days, 200 µl volume.

Group IV: PlaceboPlacebo Group1 Intervention

0.9% sodium chloride in each nostril twice daily for 21 days, 100 µl volume.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Parkinson's Disease (PD) primarily aim to restore dopaminergic function, reduce neuroinflammation, and protect neurons. Levodopa, often combined with carbidopa, is the most effective treatment, converting to dopamine in the brain to alleviate motor symptoms. Dopamine agonists mimic dopamine effects, while MAO-B inhibitors prevent dopamine breakdown. Intranasal insulin, an emerging treatment, enhances neuronal signaling and reduces inflammation, potentially offering neuroprotective benefits. These mechanisms are crucial for PD patients as they address both symptom management and underlying disease progression, improving quality of life and potentially slowing neurodegeneration.

Role of Liver Growth Factor (LGF) in Parkinson's Disease: Molecular Insights and Therapeutic Opportunities.Deferoxamine-mediated up-regulation of HIF-1α prevents dopaminergic neuronal death via the activation of MAPK family proteins in MPTP-treated mice.Mucuna pruriens reduces inducible nitric oxide synthase expression in Parkinsonian mice model.