NCT04251585

Intranasal Insulin in Parkinson's Disease

Single Center Safety and Tolerability Trial of Intranasal Insulin in Parkinson's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: HealthPartners Institute · Academic / Other
• Sex: All
• Age: 41 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Parkinson's disease (PD) is the second most common neurodegenerative disease after Alzheimer's dementia and was originally described as a motor disease. The diagnosis of PD is still based on the core motor features of bradykinesia, resting tremor, and rigidity, primarily as a result of degeneration of nigrostriatal dopaminergic neurons. In addition to the classic motor symptoms, however, PD is increasingly recognized as a multisystem disorder. A variety of non-motor symptoms, including cognitive deficits and dementia, are commonly observed in patients with PD. In this study, we aim to investigate which intranasal insulin dose out of three doses and placebo, administered at three different doses or placebo over a 21-day period, is the optimum dosage based on safety and tolerability in Parkinson's disease. A similar design was used in a trial investigating intranasal oxytocin in frontotemporal dementia. Dosing for the first two groups of this study is based on previously conducted intranasal insulin studies in Alzheimer's disease (AD) and mild cognitive impairment (MCI), using daily doses on 20 and 40 IU of intranasal insulin. Higher dose have been found to be safe in healthy adults. Prior studies performed have demonstrated favorable effects of this regimen in the MCI/AD population without peripheral hypoglycemia.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DRUG	Regular Novolin R	Intranasal insulin
DRUG	Placebo	Intranasal placebo (0.9% saline)

Timeline

• Start date: 2020-02-04
• Primary completion: 2024-08-27
• Completion: 2024-08-27
• First posted: 2020-02-05
• Last updated: 2026-02-11
• Results posted: 2026-02-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study