The Effect of Intranasal Insulin on Motor and Non-motor Symptoms in Parkinson's Disease Patients

What Was Tested

The trial (phase 2) is built around Insulin (regular human) for parkinson's disease.

This study will evaluate the effect of intranasal insulin on motor and non-motor symptoms of patients with Parkinson's disease over a 12-week period.

It had two arms (groups): Insulin (experimental) and Placebo (placebo comparator).

Normal saline, twice a day, intranasally, every day for 12 weeks.

The registry classes the interventions as drug.

More on the Plan

This study is a single-center, parallel and double-blind study.

Patients with Parkinson's disease referred to Movement Clinic of Shohada-e-Tajrish Hospital will randomly receive intranasal placebo or insulin, every day, twice a day for 12 weeks.

Motor and non-motor symptoms will be evaluated in four time points; baseline, 4, 8 and 12 weeks after treatments.

Primary outcome is motor symptoms (MDS-UPDRS; part III, IV), and secondary outcomes are motor (gait balance) and non-motor (MDS-UPDRS part I, II, cognition, depression, anxiety and fatigue) symptoms.

Who Took Part

The registry lists 28 actual participants took part.

It was open to people of any sex aged from 17 years with no upper age limit.

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

Examples of who could join: Man and woman over 17 years old. Patient with Parkinson's disease according to UK Parkinson's Disease Society Brain Bank Diagnostic Criteria. Provide written informed consent to participate in the study. Understand that they may withdraw their consent at any time.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: pregnant and lactating women; patients with diabetes and taking anti-hyperglycemic drugs; patients with other neurodegenerative diseases like multiple system atrophy, huntington's, wilson's disease, alzheimer's, amyotrophic lateral sclerosis (als), progressive supranuclear palsy, etc.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

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 2020-01-01 with completion listed for 2022-06-20.

It ran at 1 site in Iran.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, IV (time frame: Base line, 4, 8 and 12 weeks after intervention).

It also tracked 7 secondary outcomes, for example Changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I, II, Disease severity, Risk of Falling, Cognitive score, Depression score and Anxiety score.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 28 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; no results are posted to the registry yet, so nothing here describes outcomes.

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