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

Parkinson Disease Clinical Trial

Official title:

A Double-blinded Placebo-controlled Single-center Study to Evaluate the Efficacy of Intranasal Insulin 40 International Units Day as Treatment for Subjects With Parkinson Disease and Multiple System Atrophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02064166
• Other study ID #: PN-1
• Status: Completed
• Phase: Phase 2
• Start date: February 2014
• Est. completion date: September 2015

Study information

• Verified date: November 2018
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Multiple System Atrophy
• Parkinson Disease
• Shy-Drager Syndrome

Intervention

Drug:
• Intranasal Insulin
treatment arm: Insulin, 40 international units daily, intranasally, for 4 weeks; placebo arm: normal saline, daily, intranasally, for 4 weeks.

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Peter Novak

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Unified Parkinson's Disease Rating Scale Part III (UPDRS Part III)	UPDRS Part III has 14 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia. Left and right sides (arms, legs, and hands) are assessed separately for seven of the functions. The total score for subscale 3 ranges from 0 to 108 (the sum of scores from 14 items with 27 observations). The higher the value, the more severe the symptoms. The outcomes reflect the UPDRS Part III score at baseline and 4 weeks post treatment with post treatment scores compared to baseline in the insulin and placebo groups.	Baseline and post-treatment
Other	Gait Analysis (4-meter Test)	Changes in gait compared to baseline. Data are reported as changes in average stride interval ( inch) at baseline and post treatment.	Baseline and post-treatment
Other	Brief Visuospatial Memory Test-Revised (BVMT-R)	Changes in Brief Visuospatial Memory Test-Revised (BMVT-R) compared to baseline. For BVMT, there were concerns about the test administration and validity of this test which relies on fine motor control in PD patients that have motor impairment which could affect the drawing precision. Therefore, BVMT was not included in the analyses, because these methodological concerns would have affected the calculation of the total score as the outcome measure.	Baseline and post-treatment
Primary	Change in Verbal Fluency FAS (F, A or S Words) Total Score	Changes in Verbal Fluency FAS (a total number of F, A or S words) generated after 4 weeks of treatment compared to baseline, FAS total score is a sum of F,A, and S raw scores. The verbal fluency FAS test is used to assess phonemic fluency and verbal memory. Participants are asked to name words starting with letters F, A and S over one minute interval. The unit is a on scale, the normative data are adjusted for age and sex. The higher score means better verbal fluency.	Baseline and post-treatment
Secondary	Modified Hoehn and Yahr Scale	The modified Hoehn and Yahr Scale (HY) is used to assess severity of Parkinson Disease and treatment response post treatment as compared to baseline. The scale ranges from 1 to 5. The lower score indicates better outcome, e.g. less severe parkinsonism.	Baseline and post-treatment
Secondary	Cognitive Impairment Using Montreal Cognitive Assessment (MoCA)	The Montreal Cognitive Assessment (MoCA) is a one-page 30-point test administered in approximately 10 minutes and is used to assess symptoms of cognitive impairment and their changes after treatment as compared to baseline. MoCA scores range between 0 and 30 with higher scores indicative of better cognitive performance. A score of 26 and above is considered to be normal.	Baseline and post-treatment
Secondary	Beck Depression Inventory Score (BDI)	Beck Depression Inventory (BDI) is a 21-items self reported inventory with a scale evaluating depressive symptoms and the changes in BDI after treatment compared to baseline. The range of scores is 0 to 63, with higher scores indicating greater severity of depression.	Baseline and post-treatment