Evidence map›Paper›PMID 31022213›Full record

Trial reportPloS one2019

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

Peter Novak, Daniela Arantxa Pimentel Maldonado, Vera Novak

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 65 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 3 pooled it
7.7field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06072963 phase2recruitingstarted 2024, after this paper: background citation

Combination of Intranasal Insulin With Oral Semaglutide to Improve Cognition and Cerebral Blood Flow: a Feasibility Study

Ran2024Enrolled80Registered outcomes15Posted comparisons0ConditionsAlzheimer Disease, Metabolic Syndrome, Mild Cognitive ImpairmentArmsIntranasal insulin, Intranasal insulin placebo, semaglutide, Semaglutide placebo
PMID 36871874PMID 29687620PMID 33903177PMID 12821276PMID 12925848PMID 16112245PMID 17848936PMID 18367931PMID 18430999PMID 18765651PMID 19237574PMID 21911655other papers from this trial
Open the trial in the graph
NCT02064166 phase2completednot on this map

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

TypeinterventionalSponsorPeter NovakRan2014 to 2015Enrolled15ConditionsParkinson Disease, Multiple System AtrophyArmsIntranasal Insulin
3 · Its place in the literature

Who cites it

65 citing papers in PubMed, 3 syntheses or guidelines pooled it, 122 citations in OpenAlex.

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  11. Nose-to-brain drug delivery: from bench to bedside.Translational neurodegeneration · 2025
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5 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 3 institutions in 1 country.

Peter NovakDepartment of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States of America.ORCID 0000-0002-5971-1208
Daniela Arantxa Pimentel MaldonadoDepartment of Neurology, University of Massachusetts, Worcester, Massachusetts, United States of America.
Vera NovakDepartment of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America.
Beth Israel Deaconess Medical Center · USBrigham and Women's Hospital · USUniversity of Massachusetts Chan Medical School · US

Funding

NIDDK NIH HHS R01 DK103902
6 · The paper itself

Abstract

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.

Indexed as

Administration, IntranasalAgedCognitive DysfunctionDouble-Blind MethodFemaleHumansInsulinMaleMiddle AgedMultiple System AtrophyParkinson DiseasePilot ProjectsSeverity of Illness IndexInsulin

Identifiers

PMID31022213
PMCPMC6483338
OpenAlexW2940884097

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.