Intranasal Insulin in Parkinson's Disease

NCT04251585 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: A19-214
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This project will investigate exploratory outcomes related to the effect of intranasal insulin on cognition, mood, apathy and motor performance of subjects with Parkinson's disease over a 3 week period.

Conditions

Parkinson Disease

Keywords

intranasal; insulin

Outcome Measures

Primary Outcomes (4)

• Safety Measured by Count of Safety Events

  Composite safety event - this is a count of either a reduction of fasting glucose to \<70 mg/dL or an unintended reduction of weight \>5%. A larger composite event count indicates a less safe treatment.

  3 weeks

• Safety Measured by Fasting Glucose

  Pre-post change in fasting glucose (mg/dL). A larger decrease in fasting glucose indicates a less safe treatment.

  baseline and 3 weeks

• Safety Measured by Body Weight

  Pre-post change in body weight (lbs). An unintended decrease in body weight indicates a less safe treatment.

  baseline and 3 weeks

• Safety Measured by the Number of Serious Adverse Events (SAE) and Adverse Events (AE)

  Total number of AEs/SAEs during the course of treatment. More AEs/SAEs indicates a less safe treatment.

  3 weeks

Secondary Outcomes (17)

• Cognitive Function Measured by the Montreal Cognitive Assessment (MoCA)

  5 weeks

• Cognitive Function Measured by the Weschler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span

  3 weeks

• Cognitive Function Measured by the Trailmaking Test Part A Time

  baseline and 3 weeks

• Cognitive Function Measured by the Trailmaking Test Part B Time

  baseline and 3 weeks

• Cognitive Function Measured by the Trailmaking Test Parts A & B Errors

  3 weeks

Study Arms (4)

Low Insulin

EXPERIMENTAL

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

Drug: Regular Novolin R

Medium Insulin

EXPERIMENTAL

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

Drug: Regular Novolin R

High Insulin

EXPERIMENTAL

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

Drug: Regular Novolin R

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Regular Novolin R DRUG

Intranasal insulin

High Insulin; Low Insulin; Medium Insulin

Placebo DRUG

Intranasal placebo (0.9% saline)

Placebo

Eligibility Criteria

• Age: 41 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has Idiopathic PD defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following: resting tremor or rigidity and without any other known or suspected cause of Parkinsonism (according to Movement disorder society (MDS) clinical diagnostic criteria for Parkinson's disease confirmed by a fellowship trained movements disorder specialist
• Subject is Hoehn \& Yahr stage less than or equal to 3
• Subject has a MOCA score ≥10.
• Subject is \> 40 and \<90 years of age.
• Female subjects are post-menopausal or have a negative pregnancy test
• The subject must be proficient in speaking, reading and understanding English in order to comply with procedural testing of cognitive function, memory and physiology.
• 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 agents and is willing to remain on this dose for the duration of the study. If the subject is on a cholinesterase inhibitor, a stable dose without changes for 1 month is also required.
• Subject has undergone a brain CT or MRI prior to the study as part of their previous diagnostic workup for PD to rule out underlying structural lesions, as determined clinically significant by the investigator

You may not qualify if:

• Subject has atypical Parkinson's syndrome(s) due to drugs (e.g., metoclopramide, neuroleptics), metabolic neurogenetic disorders (e.g., Wilson's Disease), encephalitis, cerebrovascular disease, or degenerative disease (e.g., Progressive Supranuclear Palsy, Multiple System Atrophy, Corticobasal Degeneration, Lewy Body dementia)
• Subject has medical history and/or clinically determined disorders: chronic sinusitis, untreated thyroid disease, or significant head trauma.
• Subject has had previous nasal and/or oto-pharyngeal surgery and severe deviated septum and/or other anomalies.
• Subject has history of any psychiatric illness that would pose a safety risk to the subject as determined by investigator.
• Subject is currently taking sedative medications that are clinically contraindicated as determined by investigator.
• Subject has undergone a recent change (\<1 month) in their anti-parkinsonian medication, cholinesterase inhibitor or anti-depressant medication.
• Subject has current or recent drug or alcohol abuse or dependence as defined by Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV TR).
• Subject has participated in a clinical trial investigation within 3 months of this study.
• Subject has an insulin allergy.
• Subject has Insulin-dependent diabetes

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Insulin Resistance

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Bhavani Kashyap, PhD, MBBS
• Organization: HealthPartners Institute Neuroscience Research Center

Bhavani.X.Kashyap@HealthPartners.com

651-495-6363

Study Officials

• Julia C Johnson, MD

  HealthPartners Neurology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participants, care providers, investigators, and outcomes assessors are masked.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of 3 treatment groups or the placebo group. * 20 international units twice daily (n=7) * 40 international units twice daily (n=7) * 80 international units twice daily (n=9) * placebo (n=7)

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: February 5, 2020
• Study Start: February 4, 2020
• Primary Completion: August 27, 2024
• Study Completion: August 27, 2024
• Last Updated: February 11, 2026
• Results First Posted: February 11, 2026

Record last verified: 2026-02

Locations

US (1)