Clinical trial NCT02064166: Treatment of Parkinson Disease and Multiple System Atrophy Using Intranasal Insulin.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson Disease
Multiple System Atrophy
Keywords: Parkinson disease
Multiple system atrophy
Intranasal
Insulin
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2014-02-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Verbal Fluency FAS (F, A or S Words) Total Score
timeFrame: Baseline and post-treatment
Secondary outcomes:
measure: Modified Hoehn and Yahr Scale
timeFrame: Baseline and post-treatment
measure: Cognitive Impairment Using Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline and post-treatment
measure: Beck Depression Inventory Score (BDI)
timeFrame: Baseline and post-treatment
Other outcomes:
measure: Unified Parkinson's Disease Rating Scale Part III (UPDRS Part III)
timeFrame: Baseline and post-treatment
measure: Gait Analysis (4-meter Test)
timeFrame: Baseline and post-treatment
measure: Brief Visuospatial Memory Test-Revised (BVMT-R)
timeFrame: Baseline and post-treatment
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: Former Associate Professor
name: Peter Novak', MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.