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Insulin

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

Q: To what extent has Regular Novolin R been studied in other scenarios?

Regular Novolin R is currently being trialed in 79 active clinical studies, 13 of which are Phase 3 trials. Most of these Regular Novolin R trials are based in Sao Luis, MA; however, there are a total of 256 locations conducting these sorts of tests.

Q: Are individuals of all ages welcome in this clinical trial?

The target enrolment group for this clinical trial are individuals who between the ages of 41 and 89.

Q: What are the potential risks of Regular Novolin R?

While Phase 2 trials don't have efficacy data, there is some clinical evidence supporting Regular Novolin R's safety.

Q: What is the target number of patients for this research?

That is right, the trial detailed on clinicaltrials.gov is ongoing and still looking for patients to enroll. The study was first posted on February 4th 2020 with the latest update being October 3rd 2022. They are specifically searching for 30 individuals who meet the requirements and are local to one of the centres.

Q: What are the goals that this experiment is looking to achieve?

The purpose of this 3-week clinical trial is to establish the safety of the medication being tested. This will be done by measuring the number of safety events that occur during the study period. Additionally, cognitive function will be measured before and after taking the medication using tests for fluency, trailmaking, and WAIS-IV digit span. A lower score on these measures indicates more impairment.

Q: For which patients is this clinical trial meant?

This study is investigating whether a new treatment for [<a href="https://www.withpower.com/clinical-trials/parkinson">Parkinson</a>'s disease](https://www.withpower.com/clinical-trials/parkinson's-disease) is effective. We are looking for 30 participants who have been diagnosed with Parkinson's disease by a movement disorder specialist, and who meet the following criteria: • Subject has a MOCA score ≥10.• Subject has provided informed written consent prior to participation. In the event that subject is legally unable to provide informed written consent due to deterioration in cognitive abilities, fully informed written consent must be provided by a legally authorized representative.• Subject is on a stable dose (at least 1 month prior to baseline visit) of antiparkinsonian

Q: Are new patients being sought for this clinical trial?

That is correct. The information available on clinicaltrials.gov affirms that this study is still looking for volunteers. This particular trial was first advertised on February 4th, 2020 and updated as recently as October 3rd, 2020. They are hoping to enrol 30 patients from a single location.

Phase 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 weeks

Awards & highlights

INI-PD Trial Summary

This trial will study the effects of intranasal insulin on thinking, mood, and movement in people with Parkinson's disease.

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.Check my eligibility

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.See study design

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.

INI-PD Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 40 and 90 years old.

Select...

My mental function score is 10 or higher.

Select...

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

Select...

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

Select...

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

INI-PD Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety measured by body weight

Safety measured by count of safety events

Safety measured by fasting glucose

+1 more

Secondary outcome measures

Apathy measured by the Apathy scale

Cognitive function measured by Fluency

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

+13 more

INI-PD 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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

HealthPartners InstituteLead Sponsor

184 Previous Clinical Trials

3,716,129 Total Patients Enrolled

Julia C Johnson, MDPrincipal InvestigatorHealthPartners Neurology

Media Library

Intranasal Insulin (Insulin) Clinical Trial Eligibility Overview. Trial Name: NCT04251585 — Phase 2

Parkinson's Disease Research Study Groups: Medium Insulin, High Insulin, Placebo, Low Insulin

Parkinson's Disease Clinical Trial 2023: Intranasal Insulin Highlights & Side Effects. Trial Name: NCT04251585 — Phase 2

Intranasal Insulin (Insulin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04251585 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent has Regular Novolin R been studied in other scenarios?

"Regular Novolin R is currently being trialed in 79 active clinical studies, 13 of which are Phase 3 trials. Most of these Regular Novolin R trials are based in Sao Luis, MA; however, there are a total of 256 locations conducting these sorts of tests."

Answered by AI

Are individuals of all ages welcome in this clinical trial?

"The target enrolment group for this clinical trial are individuals who between the ages of 41 and 89."

Answered by AI

What are the potential risks of Regular Novolin R?

"While Phase 2 trials don't have efficacy data, there is some clinical evidence supporting Regular Novolin R's safety."

Answered by AI

What is the target number of patients for this research?

"That is right, the trial detailed on clinicaltrials.gov is ongoing and still looking for patients to enroll. The study was first posted on February 4th 2020 with the latest update being October 3rd 2022. They are specifically searching for 30 individuals who meet the requirements and are local to one of the centres."

Answered by AI

What are the goals that this experiment is looking to achieve?

"The purpose of this 3-week clinical trial is to establish the safety of the medication being tested. This will be done by measuring the number of safety events that occur during the study period. Additionally, cognitive function will be measured before and after taking the medication using tests for fluency, trailmaking, and WAIS-IV digit span. A lower score on these measures indicates more impairment."

Answered by AI

For which patients is this clinical trial meant?

"This study is investigating whether a new treatment for [Parkinson's disease](https://www.withpower.com/clinical-trials/parkinson's-disease) is effective. We are looking for 30 participants who have been diagnosed with Parkinson's disease by a movement disorder specialist, and who meet the following criteria: • Subject has a MOCA score ≥10.• Subject has provided informed written consent prior to participation. In the event that subject is legally unable to provide informed written consent due to deterioration in cognitive abilities, fully informed written consent must be provided by a legally authorized representative.• Subject is on a stable dose (at least 1 month prior to baseline visit) of antiparkinsonian"

Answered by AI

Are new patients being sought for this clinical trial?

"That is correct. The information available on clinicaltrials.gov affirms that this study is still looking for volunteers. This particular trial was first advertised on February 4th, 2020 and updated as recently as October 3rd, 2020. They are hoping to enrol 30 patients from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intranasal Insulin in Parkinson's Disease

2020. "Intranasal Insulin in Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04251585.

All > Insulin > Parkinson Disease