Double-Blind Placebo-Controlled Pilot Investigation of the Safety of a Single Dose of Rapid-Acting Intranasal Insulin in Down Syndrome
Abstract Background Individuals with Down syndrome are likely to develop clinical and neuropathological brain changes resembling Alzheimer’s disease dementia by the ages of 35–40 years. Intranasal insulin is a potential treatment for neurodegenerative disease that has been shown to reduce amyloid pl...
Main Authors: | , , , , , , , |
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Format: | Article |
Language: | English |
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Adis, Springer Healthcare
2020-02-01
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Series: | Drugs in R&D |
Online Access: | https://doi.org/10.1007/s40268-020-00296-2 |
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author | Michael Rosenbloom Terry Barclay Justin Johnsen Lauren Erickson Aleta Svitak Maria Pyle William Frey Leah R. Hanson |
author_facet | Michael Rosenbloom Terry Barclay Justin Johnsen Lauren Erickson Aleta Svitak Maria Pyle William Frey Leah R. Hanson |
author_sort | Michael Rosenbloom |
collection | DOAJ |
description | Abstract Background Individuals with Down syndrome are likely to develop clinical and neuropathological brain changes resembling Alzheimer’s disease dementia by the ages of 35–40 years. Intranasal insulin is a potential treatment for neurodegenerative disease that has been shown to reduce amyloid plaque burden and improve verbal memory performance in normal as well as memory-impaired adults. Investigations have shown that rapid-acting insulins may result in superior cognitive benefits compared with regular insulin. Objectives The primary objective of this study was to measure the safety and feasibility of intranasal rapid-acting glulisine in subjects with Down syndrome. Secondarily, we estimated the effects of intranasal glulisine on cognition and memory in Down syndrome. Methods A single-center, single-dose, randomized, double-blind, placebo-controlled, cross-over pilot study was performed to test the safety of intranasal glulisine vs placebo in 12 subjects with Down syndrome aged ≥ 35 years. Intranasal administration utilized the Impel NeuroPharma I109 Precision Olfactory Delivery (POD®) device. The primary outcomes were the occurrence of any or related adverse and serious adverse events. Secondary post-treatment cognitive outcome measures included performance on the Fuld Object-Memory Evaluation and Rivermead Behavioral Memory Test. Results Intranasal glulisine was safe and well tolerated in the Down syndrome population. No adverse or serious adverse events were observed. Conclusions Further investigations are necessary to better evaluate the potential cognitive-enhancing role of intranasal insulin in the Down syndrome population. ClinicalTrials.gov ID NCT02432716. |
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institution | Directory Open Access Journal |
issn | 1174-5886 1179-6901 |
language | English |
last_indexed | 2024-12-24T01:36:34Z |
publishDate | 2020-02-01 |
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series | Drugs in R&D |
spelling | doaj.art-c289a4a0a4a04de79fa55f27ae5bd12b2022-12-21T17:22:11ZengAdis, Springer HealthcareDrugs in R&D1174-58861179-69012020-02-01201111510.1007/s40268-020-00296-2Double-Blind Placebo-Controlled Pilot Investigation of the Safety of a Single Dose of Rapid-Acting Intranasal Insulin in Down SyndromeMichael Rosenbloom0Terry Barclay1Justin Johnsen2Lauren Erickson3Aleta Svitak4Maria Pyle5William Frey6Leah R. Hanson7HealthPartners Center for Memory and AgingHealthPartners Center for Memory and AgingHealthPartners Center for Memory and AgingHealthPartners InstituteHealthPartners Center for Memory and AgingHealthPartners Center for Memory and AgingHealthPartners Center for Memory and AgingHealthPartners Center for Memory and AgingAbstract Background Individuals with Down syndrome are likely to develop clinical and neuropathological brain changes resembling Alzheimer’s disease dementia by the ages of 35–40 years. Intranasal insulin is a potential treatment for neurodegenerative disease that has been shown to reduce amyloid plaque burden and improve verbal memory performance in normal as well as memory-impaired adults. Investigations have shown that rapid-acting insulins may result in superior cognitive benefits compared with regular insulin. Objectives The primary objective of this study was to measure the safety and feasibility of intranasal rapid-acting glulisine in subjects with Down syndrome. Secondarily, we estimated the effects of intranasal glulisine on cognition and memory in Down syndrome. Methods A single-center, single-dose, randomized, double-blind, placebo-controlled, cross-over pilot study was performed to test the safety of intranasal glulisine vs placebo in 12 subjects with Down syndrome aged ≥ 35 years. Intranasal administration utilized the Impel NeuroPharma I109 Precision Olfactory Delivery (POD®) device. The primary outcomes were the occurrence of any or related adverse and serious adverse events. Secondary post-treatment cognitive outcome measures included performance on the Fuld Object-Memory Evaluation and Rivermead Behavioral Memory Test. Results Intranasal glulisine was safe and well tolerated in the Down syndrome population. No adverse or serious adverse events were observed. Conclusions Further investigations are necessary to better evaluate the potential cognitive-enhancing role of intranasal insulin in the Down syndrome population. ClinicalTrials.gov ID NCT02432716.https://doi.org/10.1007/s40268-020-00296-2 |
spellingShingle | Michael Rosenbloom Terry Barclay Justin Johnsen Lauren Erickson Aleta Svitak Maria Pyle William Frey Leah R. Hanson Double-Blind Placebo-Controlled Pilot Investigation of the Safety of a Single Dose of Rapid-Acting Intranasal Insulin in Down Syndrome Drugs in R&D |
title | Double-Blind Placebo-Controlled Pilot Investigation of the Safety of a Single Dose of Rapid-Acting Intranasal Insulin in Down Syndrome |
title_full | Double-Blind Placebo-Controlled Pilot Investigation of the Safety of a Single Dose of Rapid-Acting Intranasal Insulin in Down Syndrome |
title_fullStr | Double-Blind Placebo-Controlled Pilot Investigation of the Safety of a Single Dose of Rapid-Acting Intranasal Insulin in Down Syndrome |
title_full_unstemmed | Double-Blind Placebo-Controlled Pilot Investigation of the Safety of a Single Dose of Rapid-Acting Intranasal Insulin in Down Syndrome |
title_short | Double-Blind Placebo-Controlled Pilot Investigation of the Safety of a Single Dose of Rapid-Acting Intranasal Insulin in Down Syndrome |
title_sort | double blind placebo controlled pilot investigation of the safety of a single dose of rapid acting intranasal insulin in down syndrome |
url | https://doi.org/10.1007/s40268-020-00296-2 |
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