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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluating the Effect of Intranasal Insulin Administration on Motor and Non-motor Symptoms in Parkinson's Disease Patients; a Randomized Double-blinded Placebo-controlled Clinical Trial

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: Insulin
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin<br>Regular Insulin, 20 IU twice a day, intranasally, every day for 12 weeks | Drug: Insulin<br>* 20 IU twice a day, intranasally, every day for 12 weeks<br>* Other names: Insulin regular;|
| Placebo Comparator: Placebo<br>Normal saline, twice a day, intranasally, every day for 12 weeks | Drug: Normal saline<br>* twice a day, intranasally, every day for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, IV | 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. | Base line, 4, 8 and 12 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I, II | 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. | Base line, 4, 8 and 12 weeks after intervention | 
| Disease severity | 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. | Base line, 4, 8 and 12 weeks after intervention | 
| Risk of Falling | Tinetti Balance Assessment Tool indicates the risk of falling, higher scores is indicative of low risk for falling. | Base line, 4, 8 and 12 weeks after intervention | 
| Cognitive score | The Montreal Cognitive Assessment (MoCA) scores range between 0 and 30 with higher scores indicative of better cognitive performance. | Base line, 4, 8 and 12 weeks after intervention | 
| Depression score | Beck's Depression Inventory II (BDI-II) scores range between 0 and 63; higher scores is indicative of more severe depression. | Base line, 4, 8 and 12 weeks after intervention | 
| Anxiety score | Beck Anxiety Inventory (BAI) scores range between 0 and 63; higher scores is indicative of more anxiety. | Base line, 4, 8 and 12 weeks after intervention | 
| Fatigue score | Fatigue Severity Scale (FSS) scores range between 0 and 7; higher scores is indicative of severe fatigue. | Base line, 4, 8 and 12 weeks after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, Insulin, Intranasal, Motor symptoms, Non-motor symptoms