Treatment of Parkinson Disease and Multiple System Atrophy Using Intranasal Insulin.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Parkinson disease (PD) and multiple system atrophy (MSA) are progressive neurodegenerative disorders characterized by abnormal accumulation of α-synuclein. There is no effective treatment that can slow down the disease progression and both disorders are associated with severe cognitive decline. It was shown that intranasal insulin (INI) improves learning and memory in healthy and cognitively impaired non-diabetic adults.

The proof-of-concept, randomized, placebo-controlled, cross-over pilot study ( NCT01206322) has shown that a single 40 international units dose of intranasal insulin improves visuospatial memory in diabetes and control subjects.

This proposal includes randomized, double blinded, placebo-controlled trial of intranasal insulin (40 international units daily) in treatment of PD and MSA.

The study will evaluate 22 patients with PD and 22 patients with MSA. Total duration of the study will be 2 years. The primary goal is to assess the efficacy of INI in treatment of cognitive abnormalities in both PD and MSA. The primary efficacy end point will be change of the cognitive scale ratings.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intranasal Insulin in Parkinson's Disease

NCT04251585

Parkinson Disease

COMPLETED PHASE2

Intranasal Insulin and Glutathione as an Add-On Therapy in Parkinson's Disease

NCT05266417

Parkinson Disease

RECRUITING PHASE2

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

NCT04687878

Parkinson Disease

COMPLETED PHASE2

Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's Disease

NCT00623363

Parkinson's Disease

COMPLETED PHASE2

Intranasal Human FGF-1 for Subjects With Parkinson's Disease

NCT05493462

Parkinson Disease

UNKNOWN PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson Disease Multiple System Atrophy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Insulin

40 IU of intranasal insulin daily

Group Type EXPERIMENTAL

Intranasal Insulin

Intervention Type DRUG

1. treatment arm: Insulin, 40 international units daily, intranasally, for 4 weeks;
2. placebo arm: normal saline, daily, intranasally, for 4 weeks.

Placebo

Placebo arm using intranasal normal saline

Group Type PLACEBO_COMPARATOR

Intranasal Insulin

Intervention Type DRUG

1. treatment arm: Insulin, 40 international units daily, intranasally, for 4 weeks;
2. placebo arm: normal saline, daily, intranasally, for 4 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intranasal Insulin

1. treatment arm: Insulin, 40 international units daily, intranasally, for 4 weeks;
2. placebo arm: normal saline, daily, intranasally, for 4 weeks.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Novolin R

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Males or females older than 17 years.
2. Clinical diagnosis of Parkinson disease or multiple system atrophy.
3. Provide written informed consent to participate in the study.
4. Understand that they may withdraw their consent at any time.

Exclusion Criteria

1. Women who are pregnant or lactating.
2. In the investigator's opinion, have significant systemic, hepatic, cardiovascular, renal or other illness that can interfere based on investigator judgment with the trial.
3. History of dementia.
4. Unable to walk without help for at least 1 minute.
5. History of allergic reaction to insulin.
6. The presence of inflammation of nasal cavity that may prevents absorption of insulin.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No