Clinical trial NCT04687878: The Effect of Intranasal Insulin on Motor and Non-motor Symptoms in Parkinson's Disease Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson Disease
Keywords: Parkinson's disease
Insulin
Intranasal
Motor symptoms
Non-motor symptoms
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 28
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, IV
timeFrame: Base line, 4, 8 and 12 weeks after intervention
Secondary outcomes:
measure: Changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I, II
timeFrame: Base line, 4, 8 and 12 weeks after intervention
measure: Disease severity
timeFrame: Base line, 4, 8 and 12 weeks after intervention
measure: Risk of Falling
timeFrame: Base line, 4, 8 and 12 weeks after intervention
measure: Cognitive score
timeFrame: Base line, 4, 8 and 12 weeks after intervention
measure: Depression score
timeFrame: Base line, 4, 8 and 12 weeks after intervention
measure: Anxiety score
timeFrame: Base line, 4, 8 and 12 weeks after intervention
measure: Fatigue score
timeFrame: Base line, 4, 8 and 12 weeks after intervention
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shahid Beheshti University of Medical Sciences, Shohada-e-Tajrish Hospital
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: Leila Dargahi, PharmD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shahid Beheshti University of Medical Sciences
name: Mehri Salari, MDFellowship
role: PRINCIPAL_INVESTIGATOR
affiliation: Shahid Beheshti University of Medical Sciences
name: Abolhassan Ahmadiani, PharmD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shahid Beheshti University of Medical Sciences
name: Neda Valian, PhD
role: STUDY_DIRECTOR
affiliation: Shahid Beheshti University of Medical Sciences
name: Leila Mohaghegh Shalmani, PharmD/PhD
role: STUDY_CHAIR
affiliation: Shahid Beheshti University of Medical Sciences
name: Helia Ashourizadeh, Intern
role: STUDY_CHAIR
References: