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NCT Number: NCT04687878

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Nutritional and Metabolic Diseases Parkinsonian Disorders Synucleinopathies

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shahid Beheshti University of Medical Sciences, Shohada-e-Tajrish Hospital

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin

Drug

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

Other names: Insulin regular

normal saline

Drug

twice a day, intranasally, every day for 12 weeks

Primary outcomes

  1. Changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, IV

    Time frame: 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 outcomes

  1. Changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I, II

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

dr.dargahi

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Dec 29, 2020
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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