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

Phase 2

Completed

• Conditions: Parkinson Disease
• Interventions: Drug: Insulin; Drug: Normal saline

• Registration Number: NCT04687878
• Lead Sponsor: dr.dargahi

Brief Summary

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.

Detailed Description

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. Patients, researchers (physicians, outcome assessors) and data analysts are blinded.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-12-28
• Study First Submitted QC: 2020-12-28
• Study First Posted: 2020-12-29
• Primary Completion: 2022-06-20
• Study Completion: 2023-09-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Patients who cannot walk for more than one minute without help
• A history of allergic reaction to insulin
• The presence of inflammation of nasal cavity that may prevents absorption of insulin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin	Insulin	Regular Insulin, 20 IU twice a day, intranasally, every day for 12 weeks
Placebo	Normal saline	Normal saline, twice a day, intranasally, every day for 12 weeks

Primary Outcome Measures

Name	Time	Method
Changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, IV	Base line, 4, 8 and 12 weeks after intervention	Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III, IV assess the motor signs of Parkinson's Disease; higher score means more severity of the motor symptoms.

Secondary Outcome Measures

Name	Time	Method
Cognitive score	Base line, 4, 8 and 12 weeks after intervention	The Montreal Cognitive Assessment (MoCA) scores range between 0 and 30 with higher scores indicative of better cognitive performance.
Disease severity	Base line, 4, 8 and 12 weeks after intervention	The modified Hoehn and Yahr Scale (HY) is used to assess severity of Parkinson's Disease. The scale ranges from 1 to 5. The lower score indicates better outcome.
Changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I, II	Base line, 4, 8 and 12 weeks after intervention	Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part I, II assess the non motor signs of PD; higher score means more severity of the symptoms.
Risk of Falling	Base line, 4, 8 and 12 weeks after intervention	Tinetti Balance Assessment Tool indicates the risk of falling, higher scores is indicative of low risk for falling.
Depression score	Base line, 4, 8 and 12 weeks after intervention	Beck's Depression Inventory II (BDI-II) scores range between 0 and 63; higher scores is indicative of more severe depression.
Anxiety score	Base line, 4, 8 and 12 weeks after intervention	Beck Anxiety Inventory (BAI) scores range between 0 and 63; higher scores is indicative of more anxiety.
Fatigue score	Base line, 4, 8 and 12 weeks after intervention	Fatigue Severity Scale (FSS) scores range between 0 and 7; higher scores is indicative of severe fatigue.

Trial Locations

Locations (1)

Shahid Beheshti University of Medical Sciences, Shohada-e-Tajrish Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of