Journal Article

Safety and preliminary efficacy of intranasal insulin for cognitive impairment in Parkinson disease and multiple system atrophy: A double-blinded placebo-controlled pilot study

Pimentel Maldonado, Daniela Arantxa, Novak, Peter, Novak, Vera

2019

Overview

Parkinson disease (PD) is associated with cognitive impairment. We aimed to determine the effects of intranasal insulin (INI) on cognition and motor performance in PD. This was a proof of concept, randomized, double-blinded, placebo-controlled trial evaluating the effects of 40 international units (IU) of insulin or saline once daily for four weeks on cognitive and functional performance. Of 16 subjects enrolled, eight in the INI group and six in the placebo group completed verbal fluency (FAS), Unified Parkinson Disease Scale (UPDRS), and modified Hoehn and Yahr scale (HY, PD severity) at baseline and post-treatment and were included in the analyses. After treatment, the INI group had a better total FAS score (p = 0.02) (41 ± 8.2 vs. 30.8 ± 7.1, mean ±SD, p = 0.02) compared to the placebo group. The INI group also had improved HY (p = 0.04) and UPDRS-Motor (Part III) (p = 0.02) scores when compared to baseline. One INI treated patient with multiple system atrophy (MSA) remained stable and did not show disease progression. The placebo group had no change. INI administration was well tolerated and there were no hypoglycemic episodes or serious study related adverse events or medications interactions. INI is safe in PD and MSA patients and may provide clinically relevant functional improvement. Larger studies are warranted to determine the INI effect in treatment of cognitive and motor impairment in Parkinson disease. Trial Registration: ClinicalTrial.gov NCT02064166.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Activities of daily living / Administration, Intranasal / Age / Aged / Atrophy / Brain research / Clinical trials / Cognition / Cognition & reasoning / Cognitive ability / Cognitive disorders / Cognitive Dysfunction - drug therapy / Cognitive Dysfunction - pathology / Cognitive impairment / Dementia / Development and progression / Diabetes / Diabetes therapy / Diagnosis / Disease control / Dosage and administration / Double-Blind Method / Drug therapy / Drugs / Entacapone / Female / Humans / Hypoglycemia / Impairment / Insulin / Insulin - administration & dosage / Insulin resistance / Laboratories / Male / Memory / Middle Aged / Motor task performance / Motors / Movement disorders / Multiple system atrophy / Multiple System Atrophy - drug therapy / Multiple System Atrophy - pathology / Neurodegenerative diseases / Neurology / Older people / Parkinson disease / Parkinson Disease - drug therapy / Parkinson Disease - pathology / Parkinson's disease / Patient outcomes / Pharmacy / Pilot Projects / Rasagiline / Ropinirole / Severity of Illness Index / Type 2 diabetes / Walking / Womens health