Intranasal Insulin in Parkinson's Disease

What Was Tested

This registered phase 2 trial tested Insulin (regular human) for parkinson's disease.

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.

It had four arms (groups): Low Insulin (experimental), Medium Insulin (experimental), High Insulin (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

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.

A variety of non-motor symptoms, including cognitive deficits and dementia, are commonly observed in patients with PD.

A similar design was used in a trial investigating intranasal oxytocin in frontotemporal dementia.

Who Took Part

Enrollment: 31 actual participants took part.

It was open to people of any sex aged from 41 years up to 89 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 9 inclusion and 12 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the parkinson's disease participants stayed in one arm throughout.

As a double-blind Insulin (regular human) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2020-02-04 with completion listed for 2024-08-27.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Safety Measured by Count of Safety Events (time frame: 3 weeks). Safety Measured by Fasting Glucose (time frame: baseline and 3 weeks). Safety Measured by Body Weight (time frame: baseline and 3 weeks).

It also tracked 17 secondary outcomes, for example Cognitive Function Measured by the Montreal Cognitive Assessment (MoCA), Cognitive Function Measured by the Weschler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span, Cognitive Function Measured by the Trailmaking Test Part A Time, Cognitive Function Measured by the Trailmaking Test Part B Time, Cognitive Function Measured by the Trailmaking Test Parts A & B Errors and Cognitive Function Measured by the Judgement of Line Orientation.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 31 people with parkinson's disease.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin (regular human) compound page, Parkinson's disease research.