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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04687878
• Other study ID #: IR.SBMU.PHNS.REC.1398.094
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2020
• Est. completion date: September 20, 2023

Study information

• Verified date: April 2024
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 20, 2023
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Insulin
20 IU twice a day, intranasally, every day for 12 weeks
• Normal saline
twice a day, intranasally, every day for 12 weeks

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shahid Beheshti University of Medical Sciences, Shohada-e-Tajrish Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
dr.dargahi

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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