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

dr.dargahi

Status and phase: Completed; Phase 2

Conditions: Parkinson Disease

Treatments: Drug: Normal saline; Drug: Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT04687878

IR.SBMU.PHNS.REC.1398.094

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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28 participants in 2 patient groups, including a placebo group

Insulin

Experimental group

Description:

Regular Insulin, 20 IU twice a day, intranasally, every day for 12 weeks

Treatment:

Drug: Insulin

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal saline