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
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. ;
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