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

Recruiting in Palo Alto (17 mi)

Overseen byJulia C Johnson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: HealthPartners Institute

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

I have given or my legal representative has given written consent for me to participate.

I am between 40 and 90 years old.

The subject must be proficient in speaking, reading and understanding English in order to comply with procedural testing of cognitive function, memory and physiology

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Exclusion Criteria

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

I changed my Parkinson's or depression medication less than a month ago.

Screening laboratory results that are medically relevant, in which inclusion would pose a safety risk to the subject as determined by investigator

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Treatment Details

Interventions

Intranasal Insulin (Insulin)

Trial OverviewThe 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.

Participant Groups

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.