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

• Sponsor: dr.dargahi (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04687878
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 30
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Drug: Insulin; Drug: Normal saline	Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 1, 2020
• Anticipated Primary Completion Date: Jan 1, 2022
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Insulin Regular Insulin, 20 IU twice a day, intranasally, every day for 12 weeks	Drug: Insulin; 20 IU twice a day, intranasally, every day for 12 weeks; Other Names: Insulin regular
Placebo Comparator: Placebo Normal saline, twice a day, intranasally, every day for 12 weeks	Drug: Normal saline; twice a day, intranasally, every day for 12 weeks

Outcome Measures

Primary Outcome Measures

1. Changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, IV [Base line, 4, 8 and 12 weeks after intervention]

   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.

Secondary Outcome Measures

1. Changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I, II [Base line, 4, 8 and 12 weeks after intervention]

   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.

2. Disease severity [Base line, 4, 8 and 12 weeks after intervention]

   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.

3. Risk of Falling [Base line, 4, 8 and 12 weeks after intervention]

   Tinetti Balance Assessment Tool indicates the risk of falling, higher scores is indicative of low risk for falling.

4. Cognitive score [Base line, 4, 8 and 12 weeks after intervention]

   The Montreal Cognitive Assessment (MoCA) scores range between 0 and 30 with higher scores indicative of better cognitive performance.

5. Depression score [Base line, 4, 8 and 12 weeks after intervention]

   Beck's Depression Inventory II (BDI-II) scores range between 0 and 63; higher scores is indicative of more severe depression.

6. Anxiety score [Base line, 4, 8 and 12 weeks after intervention]

   Beck Anxiety Inventory (BAI) scores range between 0 and 63; higher scores is indicative of more anxiety.

7. Fatigue score [Base line, 4, 8 and 12 weeks after intervention]

   Fatigue Severity Scale (FSS) scores range between 0 and 7; higher scores is indicative of severe fatigue.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shahid Beheshti University of Medical Sciences, Shohada-e-Tajrish Hospital	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

• dr.dargahi

Investigators

• Principal Investigator: Leila Dargahi, PharmD/PhD, Shahid Beheshti University of Medical Sciences
• Principal Investigator: Mehri Salari, MDFellowship, Shahid Beheshti University of Medical Sciences
• Principal Investigator: Abolhassan Ahmadiani, PharmD/PhD, Shahid Beheshti University of Medical Sciences
• Study Director: Neda Valian, PhD, Shahid Beheshti University of Medical Sciences
• Study Chair: Leila Mohaghegh Shalmani, PharmD/PhD, Shahid Beheshti University of Medical Sciences
• Study Chair: Helia Ashourizadeh, Intern, Shahid Beheshti University of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: dr.dargahi, Associate professor, Shahid Beheshti University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT04687878
• Other Study ID Numbers: IR.SBMU.PHNS.REC.1398.094
• First Posted: Dec 29, 2020
• Last Update Posted: Mar 18, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by dr.dargahi, Associate professor, Shahid Beheshti University of Medical Sciences: Parkinson's disease; Insulin; Intranasal; Motor symptoms; Non-motor symptoms
• Additional relevant MeSH terms: Parkinson Disease; Insulin; Insulin, Globin Zinc

Study Results

No Results Posted as of Mar 18, 2021