Evidence map›Paper›PMID 27434297›Full record

Trial reportJournal of Parkinson's disease2016

Nilotinib Effects in Parkinson's disease and Dementia with Lewy bodies.

Fernando Pagan, Michaeline Hebron, Ellen H Valadez, Yasar Torres-Yaghi, Xu Huang, Reversa R Mills, Barbara M Wilmarth, Hellen Howard, Connell Dunn, Alexis Carlson and 6 more

3 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of Parkinson's disease, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 143 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
143citing papers in PubMed, 2 pooled it
20.4field-weighted citation impact, top 1% 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.

NCT02947893 phase2completednot on this mapstarted 2017, after this paper: background citation

A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Impact of Low Doses of Nilotinib (Tasigna®) on Safety, Biomarkers and Clinical Outcomes in Subjects With Mild to Moderate Alzheimer's Disease

TypeinterventionalSponsorGeorgetown UniversityRan2017 to 2021Enrolled37ConditionsAlzheimer's DiseaseArmsPlacebo Capsule(s) Once a Day by Mouth, Nilotinib Capsule(s) Once a Day by Mouth
NCT02954978 phase2completednot on this mapstarted 2017, after this paper: background citation

A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Impact of Low Doses of Nilotinib Treatment on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's Disease

TypeinterventionalSponsorGeorgetown UniversityRan2017 to 2020Enrolled75ConditionsParkinson Disease, Parkinsons Disease With DementiaArmsPlacebo Oral Capsule, Nilotinib 150mg oral capsule [Tasigna], Nilotinib 300mg oral capsule [Tasigna]
NCT03764215 phase1unknown statusnot on this mapstarted 2018, after this paper: background citation

An Open Label, Phase Ib Study to Evaluate the Impact of Low Doses of Nilotinib Treatment on Safety, Tolerability and Biomarkers in Huntington's Disease

TypeinterventionalSponsorGeorgetown UniversityRan2018 to 2020Enrolled10ConditionsHuntington DiseaseArmsNilotinib 150 MG
3 · Its place in the literature

Who cites it

143 citing papers in PubMed, 2 syntheses or guidelines pooled it, 261 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Long-Term Safety and Clinical Effects of Nilotinib in Parkinson's Disease.Movement disorders : official journal of the Movement Disorder Society · 2021
    Trial
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  6. Tyrosine kinase inhibitor use and risk of neurodegenerative disease: A Swedish population-based cohort study.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026
    Article
  7. Review
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83 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 2 institutions in 1 country.

Fernando PaganDepartment of Neurology, National Parkinson's Foundation Center for Excellence, Translational Neurotherapeutics Program. Movement Disorders Program. MedStar Georgetown Hospital Washington, DC, USA.
Michaeline HebronDepartment of Neurology, Laboratory for Dementia and Parkinsonism, National Parkinson's Foundation Center for Excellence, Translational Neurotherapeutics Program. Georgetown University Medical Center, Washington, DC, USA.
Ellen H ValadezDepartment of Neurology, National Parkinson's Foundation Center for Excellence, Translational Neurotherapeutics Program. Movement Disorders Program. MedStar Georgetown Hospital Washington, DC, USA.
Yasar Torres-YaghiDepartment of Neurology, National Parkinson's Foundation Center for Excellence, Translational Neurotherapeutics Program. Movement Disorders Program. MedStar Georgetown Hospital Washington, DC, USA.
Xu HuangDepartment of Neurology, Laboratory for Dementia and Parkinsonism, National Parkinson's Foundation Center for Excellence, Translational Neurotherapeutics Program. Georgetown University Medical Center, Washington, DC, USA.
Reversa R MillsDepartment of Neurology, National Parkinson's Foundation Center for Excellence, Translational Neurotherapeutics Program. Movement Disorders Program. MedStar Georgetown Hospital Washington, DC, USA.
Barbara M WilmarthDepartment of Neurology, National Parkinson's Foundation Center for Excellence, Translational Neurotherapeutics Program. Movement Disorders Program. MedStar Georgetown Hospital Washington, DC, USA.
Hellen HowardDepartment of Neurology, National Parkinson's Foundation Center for Excellence, Translational Neurotherapeutics Program. Movement Disorders Program. MedStar Georgetown Hospital Washington, DC, USA.
Connell DunnDepartment of Neurology, National Parkinson's Foundation Center for Excellence, Translational Neurotherapeutics Program. Movement Disorders Program. MedStar Georgetown Hospital Washington, DC, USA.
Alexis CarlsonDepartment of Neurology, National Parkinson's Foundation Center for Excellence, Translational Neurotherapeutics Program. Movement Disorders Program. MedStar Georgetown Hospital Washington, DC, USA.
Abigail LawlerDepartment of Neurology, National Parkinson's Foundation Center for Excellence, Translational Neurotherapeutics Program. Movement Disorders Program. MedStar Georgetown Hospital Washington, DC, USA.
Sean L RogersDepartment of Neurology, National Parkinson's Foundation Center for Excellence, Translational Neurotherapeutics Program. Movement Disorders Program. MedStar Georgetown Hospital Washington, DC, USA.
Ramsey A FalconerDepartment of Neurology, National Parkinson's Foundation Center for Excellence, Translational Neurotherapeutics Program. Movement Disorders Program. MedStar Georgetown Hospital Washington, DC, USA.
Jaeil AhnDepartment of Biostatistics, Georgetown University Medical Center, Washington, DC, USA.
Zhaoxia LiDepartment of Neurology, National Parkinson's Foundation Center for Excellence, Translational Neurotherapeutics Program. Movement Disorders Program. MedStar Georgetown Hospital Washington, DC, USA.
Charbel MoussaDepartment of Neurology, Laboratory for Dementia and Parkinsonism, National Parkinson's Foundation Center for Excellence, Translational Neurotherapeutics Program. Georgetown University Medical Center, Washington, DC, USA.
Foundation Center · USGeorgetown University · US

Funding

Maternal Morbidity and Mortality: Risk Factors, Early Detection and Personalized InterventionUL1TR001409 · NCATS · GEORGETOWN UNIVERSITY · PI GONDRE-LEWIS, MARJORIE C, MELLMAN, THOMAS A · 2015 to 2024
$37.8M
Georgetown-Howard Universities Center for Clinical and Translational Science (GHUUL1TR000101 · NCATS · GEORGETOWN UNIVERSITY · PI MELLMAN, THOMAS A, VERBALIS, JOSEPH G · 2012 to 2015
$19.3M
Georgetown-Howard Universities Center for Clinical and Translational Science (GHUUL1RR031975 · NCRR · GEORGETOWN UNIVERSITY · PI VERBALIS, JOSEPH G · 2010 to 2011
$14.6M
NCATS NIH HHS UL1 TR000101NCATS NIH HHS UL1 TR001409NCRR NIH HHS UL1 RR031975
6 · The paper itself

Abstract

backgroundWe evaluated the effects of low doses of the tyrosine kinase Abelson (Abl) inhibitor Nilotinib, on safety and pharmacokinetics in Parkinson's disease dementia or dementia with Lewy bodies.

objectivesThe primary outcomes of this study were safety and tolerability; pharmacokinetics and target engagement were secondary, while clinical outcomes were exploratory.

methodsTwelve subjects were randomized into 150 mg (n = 5) or 300 mg (n = 7) groups and received Nilotinib orally every day for 24 weeks.

resultsThis study shows that 150 mg and 300 mg doses of Nilotinib appear to be safe and tolerated in subjects with advanced Parkinson's disease. Nilotinib is detectable in the cerebrospinal fluid (CSF) and seems to engage the target Abl. Motor and cognitive outcomes suggest a possible beneficial effect on clinical outcomes. The CSF levels of homovanillic acid are significantly increased between baseline and 24 weeks of treatment. Exploratory CSF biomarkers were measured.

conclusionsThis small proof-of-concept study lacks a placebo group and participants were not homogenous, resulting in baseline differences between and within groups. This limits the interpretations of the biomarker and clinical data, and any conclusions should be drawn cautiously. Nonetheless, the collective observations suggest that it is warranted to evaluate the safety and efficacy of Nilotinib in larger randomized, double-blind, placebo-controlled trials.

Indexed as

Outcome Assessment, Health CareDementiaFollow-Up StudiesHumansLewy Body DiseaseParkinson DiseasePyrimidinesnilotinibPyrimidinesdopaminehomovanillic acidLewy bodiesNilotinibParkinsonsynucleintau

Identifiers

PMID27434297
PMCPMC5008228
OpenAlexW2462137239

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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 OpenQuestion graph.