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