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

NCT02064166 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: PN-1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease; Multiple System Atrophy

Keywords

Parkinson disease; Multiple system atrophy; Intranasal; Insulin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Modified Hoehn and Yahr Scale

  Baseline and post-treatment

• Cognitive Impairment Using Montreal Cognitive Assessment (MoCA)

  Baseline and post-treatment

• Beck Depression Inventory Score (BDI)

  Baseline and post-treatment

Other Outcomes (3)

• Unified Parkinson's Disease Rating Scale Part III (UPDRS Part III)

  Baseline and post-treatment

• Gait Analysis (4-meter Test)

  Baseline and post-treatment

• Brief Visuospatial Memory Test-Revised (BVMT-R)

  Baseline and post-treatment

Study Arms (2)

Insulin

EXPERIMENTAL

40 IU of intranasal insulin daily

Drug: Intranasal Insulin

Placebo

PLACEBO COMPARATOR

Placebo arm using intranasal normal saline

Drug: Intranasal Insulin

Interventions

Intranasal Insulin DRUG

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

Also known as: Novolin R

Insulin; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peter Novak: lead

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (1)

• Novak P, Pimentel Maldonado DA, Novak V. Safety and preliminary efficacy of intranasal insulin for cognitive impairment in Parkinson disease and multiple system atrophy: A double-blinded placebo-controlled pilot study. PLoS One. 2019 Apr 25;14(4):e0214364. doi: 10.1371/journal.pone.0214364. eCollection 2019.

  PMID: 31022213 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Multiple System Atrophy; Insulin Resistance

Interventions

Insulin

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Peter Novak, MD PhD
• Organization: Brigham & Women's Hospital

pnovak2@bwh.harvard.edu

617-732-8896

Study Officials

• Peter Novak', MD,PhD

  Former Associate Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Former Faculty member

Study Record Dates

• First Submitted: February 13, 2014
• First Posted: February 17, 2014
• Study Start: February 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 23, 2018
• Results First Posted: November 23, 2018

Record last verified: 2018-11

Locations

US (1)